Slide specimen confirmation assistance system, slide specimen confirmation assistance device, and slide specimen confirmation assistance method

Abstract

This slide specimen confirmation assistance system comprises: an image acquisition means for acquiring, for a gene panel test, an image of a first stained slide specimen in which a first target region is marked by a physician; a first output means for outputting the result of estimation of the tumor cell content proportion of the first target region; an identification means for identifying a second target region on the first stained slide specimen; a second output means for outputting the result of estimation of the tumor cell content proportion of the second target region; and a first generation means for generating, according to an instruction from a user, target region change information indicating that the second target region is to be used.

Description

Slide Specimen Confirmation Support System, Slide Specimen Confirmation Support Device, and Slide Specimen Confirmation Support Method

[0001] The present disclosure relates to a system for supporting the confirmation of a slide specimen for gene panel testing, a device for supporting the confirmation of a slide specimen for gene panel testing, and a method for supporting the confirmation of a slide specimen for gene panel testing.

[0002] In gene panel testing, in order to identify the region for separating the cells to be tested, a doctor marks the target region on the slide specimen. For example, the doctor estimates the proportion of tumor cells, etc., and marks the target region based on the estimate. However, when the target region is marked based on an estimate, the separated cells may not be suitable for the test, and the test may fail. When the test fails, a number of problems occur, such as waste of the doctor's and technician's time, waste of test samples, and delay in treatment for the patient, for retesting.

[0003] Patent Document 1 describes automatically selecting a region of interest (ROI) in a tissue slide, separating the ROI, and performing a molecular test. Patent Document 2 describes a technique for calculating the tumor cell ratio using a machine learning model and selecting a tissue site for gene panel testing.

[0004] Japanese Patent Application Laid-Open No. 2015-533086 Japanese Patent Application Laid-Open No. 2024-518694

[0005] However, although Patent Documents 1 and 2 describe techniques for automatically selecting a target region in a slide specimen, nothing is described about a technique for supporting the confirmation (double-check) of whether the target region marked by the doctor is appropriate.

[0006] If it is possible to support the confirmation of whether the target region marked by the doctor is appropriate, the target region can be made more appropriate with greater certainty, and the test can be effectively executed.

[0007] This disclosure has been made in view of the above-mentioned issues, and one exemplary purpose is to provide a technology that helps to verify whether the target region marked by a physician in a slide specimen for gene panel testing is appropriate.

[0008] A slide specimen confirmation support system relating to an exemplary aspect of this disclosure comprises: an image acquisition means for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target area has been marked by a physician; a first output means for outputting an estimated result based on the image regarding the tumor cell content of the first target area; an identification means for identifying a second target area on the first stained slide specimen; a second output means for outputting an estimated result based on the image regarding the tumor cell content of the second target area; and a first generation means for generating target area change information indicating the use of the second target area in response to instructions from the user.

[0009] A slide specimen confirmation support device relating to an exemplary aspect of the present disclosure comprises: an image acquisition means for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target area has been marked by a physician; a first output means for outputting an estimated result based on the image regarding the tumor cell content of the first target area; an identification means for identifying a second target area on the first stained slide specimen; a second output means for outputting an estimated result based on the image regarding the tumor cell content of the second target area; and a first generation means for generating target area change information indicating the use of the second target area in response to instructions from the user.

[0010] A slide specimen confirmation support method relating to an illustrative aspect of this disclosure includes: acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target region has been marked by a physician; outputting an estimated result based on the image regarding the tumor cell content of the first target region; identifying a second target region on the first stained slide specimen; outputting an estimated result based on the image regarding the tumor cell content of the second target region; and generating target region change information indicating the use of the second target region in response to instructions from the user.

[0011] A slide specimen verification support program relating to an exemplary aspect of this disclosure causes at least one processor to execute: an image acquisition process for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target area has been marked by a physician; a first output process for outputting an estimated result based on the image regarding the tumor cell content of the first target area; an identification process for identifying a second target area on the first stained slide specimen; a second output process for outputting an estimated result based on the image regarding the tumor cell content of the second target area; and a first generation process for generating target area change information indicating the use of the second target area in response to instructions from the user.

[0012] One illustrative aspect of this disclosure provides a technique that can assist in confirming whether the target region marked by a physician in a slide specimen for gene panel testing is appropriate.

[0013] This is a block diagram showing the configuration of the slide specimen verification support system related to this disclosure. This is a block diagram showing the configuration of the slide specimen verification support device related to this disclosure. This is a flowchart showing the flow of the slide specimen verification support method related to this disclosure. This is a flowchart showing the flow of the gene panel test related to this disclosure. This is a diagram showing examples of specimens and slide specimens used in the gene panel test related to this disclosure. This is a diagram showing an example of a slide specimen set used in the gene panel test related to this disclosure. This is a diagram showing an example of a stained slide specimen used in the gene panel test related to this disclosure. This is a block diagram showing the configuration of the slide specimen verification support system related to this disclosure. This is a diagram showing an example of the display in the slide specimen verification support system related to this disclosure. This is a diagram showing another example of the display in the slide specimen verification support system related to this disclosure. This is a diagram showing an example of a stained slide specimen related to this disclosure. This is a block diagram showing the configuration of the slide specimen verification support system related to this disclosure. This is a block diagram showing the configuration of the slide specimen verification support device related to this disclosure. This is a block diagram showing the configuration of a computer that constitutes part of the slide specimen verification support system or functions as a slide specimen verification support device related to this disclosure.

[0014] The following are examples of embodiments of the present invention. However, the present invention is not limited to the exemplary embodiments shown below, and various modifications are possible within the scope of the claims. For example, embodiments obtained by appropriately combining some or all of the technologies (things or methods) employed in each of the exemplary embodiments shown below may also be included in the scope of the present invention. Furthermore, embodiments obtained by appropriately omitting some of the technologies employed in each of the exemplary embodiments shown below may also be included in the scope of the present invention. In addition, the effects mentioned in each of the exemplary embodiments shown below are examples of effects that can be expected in that exemplary embodiment and do not define the scope of the present invention. That is, embodiments that do not produce the effects mentioned in each of the exemplary embodiments shown below may also be included in the scope of the present invention.

[0015] [First Exemplary Embodiment] A first exemplary embodiment, which is an example of an embodiment of the present invention, will be described in detail with reference to the drawings. This exemplary embodiment is the basic form for each of the exemplary embodiments described later. The scope of application of each technology adopted in this exemplary embodiment is not limited to this exemplary embodiment. That is, each technology adopted in this exemplary embodiment can also be adopted in other exemplary embodiments included in this disclosure, to the extent that no particular technical problems occur. Furthermore, each technology shown in the drawings referenced to explain this exemplary embodiment can also be adopted in other exemplary embodiments included in this disclosure, to the extent that no particular technical problems occur.

[0016] (Configuration of the slide specimen verification support system) The configuration of the slide specimen verification support system 1 will be explained with reference to Figure 1. Figure 1 is a block diagram showing the configuration of the slide specimen verification support system 1. As shown in Figure 1, the slide specimen verification support system 1 includes an image acquisition unit (image acquisition means) 11, a first output unit (first output means) 12, a identification unit (identification means) 13, a second output unit (second output means) 14, and a first generation unit (first generation means) 15.

[0017] The image acquisition unit 11 acquires an image of the first stained slide specimen. In one example, the image acquisition unit 11 is connected to an external imaging device and may acquire an image of the first stained slide specimen captured by the external imaging device. In another example, the image acquisition unit 11 is an imaging device and may acquire an image of the first stained slide specimen by imaging the first stained slide specimen. In yet another example, the image acquisition unit 11 is connected to an external storage device and may acquire an image of the first stained slide specimen stored in the external storage device.

[0018] The first stained slide is a stained slide for gene panel testing. The first stained slide has the first target region marked by the physician. Gene panel testing, also known as cancer gene panel testing, is a test that detects changes in multiple cancer-related genes. The set of cancer-related genes targeted for testing is called a panel. The types and number of genes included in the panel vary depending on the purpose. One example of the purpose of gene panel testing is to determine the drugs to be used in drug therapy, in particular, to determine molecularly targeted therapies. The effectiveness of molecularly targeted therapies and the types of molecularly targeted therapies that are effective change depending on mutations in cancer-related genes, so by performing gene panel testing, it is possible to determine the appropriate drug.

[0019] Genetic panel testing typically uses multiple slide specimens (referred to herein as "slide specimen sets"). First, a sample such as tissue is collected from the subject. In one example, the sample is formalin-fixed and paraffin-embedded (FFPE) and stored as an FFPE block. Then, multiple slide specimens are prepared from sections obtained by thinly slicing the FFPE block. Some or all of the slide specimens prepared from the same FFPE block can be used as a slide specimen set. Some slide specimens are stained with hematoxylin-eosin (HE) staining or the like and are called stained slide specimens. Slide specimens that have not been stained are called unstained slide specimens. In one example, a slide specimen set includes both stained slide specimens and unstained slide specimens.

[0020] In gene panel testing, a region containing a high concentration of tumor cells is excised from an unstained slide specimen included in a slide specimen set, and the excised sample is subjected to a next-generation sequencer or similar device to detect changes in cancer-related genes. The target region of the stained slide specimen refers to the area that is marked in advance on the stained slide specimen to determine the position from which the sample will be excised. In one example, the sample is excised from the unstained slide specimen according to the target region marked on the stained slide specimen.

[0021] The first output unit 12 outputs an estimated result for the tumor cell content of the first target area based on the image of the first stained slide specimen. The tumor cell content of the target area means the proportion of tumor cells among the cells contained in the target area. The manner of output is not particularly limited as long as it is a manner in which the user can ultimately confirm the output, but for example, it may be displayed on a display device (not shown). Since tumor cells and normal cells differ in shape and the characteristics of the cells themselves, the number of tumor cells and the number of normal cells in the target area can be calculated using image recognition technology, and the tumor cell content of the target area can be estimated.

[0022] The identification unit 13 identifies a second target area on the first stained slide specimen. The second target area may be a different area from the first target area. The identification unit 13 may identify the second target area in response to user input, or it may identify the second target area automatically. The user input may specify the location of the second target area, or it may specify the conditions that the second target area must satisfy. If there is no user input, the identification unit 13 does not need to identify the second target area.

[0023] The second output unit 14 outputs the estimated result of the tumor cell content of the second target region based on the first stained slide specimen. The manner of output is not particularly limited as long as it is in a manner that the user can ultimately confirm, but for example, it may be displayed on a display device (not shown).

[0024] The first generation unit 15 generates target area change information indicating the use of a second target area in response to user input. The target area change information indicates that the second target area will be used instead of the first target area as the target area of ​​the first stained slide specimen. The target area change information also includes information indicating the position of the second target area.

[0025] (Effects of the slide specimen verification support system) As described above, the slide specimen verification support system 1 outputs an estimated result of the tumor cell content of the first target area based on the image of the first stained slide specimen. Therefore, the user of the slide specimen verification support system 1 can confirm whether the first target area is appropriate. In addition, a second target area is identified, and an estimated result of the tumor cell content of the second target area is output. This allows the user to confirm whether the second target area is appropriate. If, for example, the first target area is not appropriate and the second target area is appropriate, target area change information indicating the use of the second target area is generated in response to the user's input. This allows the user to change the target area of ​​the first stained slide specimen as needed. In other words, the slide specimen verification support system 1 provides an exemplary effect of providing a technology that supports the confirmation of whether the target area marked by a physician in a slide specimen for gene panel testing is appropriate and the changing of the target area as needed.

[0026] (Configuration of the slide specimen verification support device) The configuration of the slide specimen verification support device 100 will be explained with reference to Figure 2. Figure 2 is a block diagram showing the configuration of the slide specimen verification support device 100. As shown in Figure 2, the slide specimen verification support device 100 includes an image acquisition unit 11, a first output unit 12, a identification unit 13, a second output unit 14, and a first generation unit 15. In other words, the slide specimen verification support device 100 includes all the components of the slide specimen verification support system 1.

[0027] (Effects of the slide specimen verification support device) As described above, the slide specimen verification support device 100 employs the same configuration as the slide specimen verification support system 1. Therefore, the slide specimen verification support device 100 provides an exemplary effect of being able to confirm whether the target area marked by a physician in a slide specimen for gene panel testing is appropriate and to support the modification of the target area as necessary.

[0028] (Flowchart of Slide Specimen Verification Support Method) The flowchart of the slide specimen verification support method S10 will be explained with reference to Figure 3. Figure 3 is a flowchart showing the flowchart of the slide specimen verification support method S10. As shown in Figure 3, the slide specimen verification support method S10 includes an image acquisition process S11, a first output process S12, a specific process S13, a second output process S14, and a first generation process S15.

[0029] In the image acquisition process S11, for example, one or more processors acquire an image of a first stained slide specimen for gene panel testing, the first stained slide specimen having been marked with a first target region by a physician.

[0030] In the first output processing S12, for example, one or more processors output an estimation result for the tumor cell content of the first target region based on the image of the first stained slide specimen.

[0031] In the specific processing S13, for example, one or more processors identify a second target region on the first stained slide specimen in response to input from the user.

[0032] In the second output processing S14, the estimated percentage of tumor cells in the second target region is output based on the image of the first stained slide specimen.

[0033] In the first generation process S15, target area change information is generated in response to user input, indicating that the second target area will be used.

[0034] (Effects of the slide specimen verification support method) As described above, the slide specimen verification support method S10 employs the same configuration as the slide specimen verification support system 1. Therefore, the slide specimen verification support method S10 provides one exemplary effect: it can provide a technology that helps to confirm whether the target region marked by a physician in a slide specimen for gene panel testing is appropriate and to change the target region as necessary.

[0035] [Second Exemplary Embodiment] A second exemplary embodiment, which is an example of an embodiment of the present invention, will be described in detail with reference to the drawings. Components having the same function as those described in the above-described exemplary embodiment are denoted by the same reference numerals, and their descriptions are omitted as appropriate. The scope of application of each technology adopted in this exemplary embodiment is not limited to this exemplary embodiment. That is, each technology adopted in this exemplary embodiment can also be adopted in other exemplary embodiments included in this disclosure, to the extent that no particular technical problems arise. Furthermore, each technology shown in the drawings referenced to describe this exemplary embodiment can also be adopted in other exemplary embodiments included in this disclosure, to the extent that no particular technical problems arise.

[0036] (Flow of Gene Panel Testing) An example of the flow of gene panel testing (including preparation) in this exemplary embodiment will be explained with reference to Figures 4 to 7. Figure 4 is a flowchart of an example of the flow of gene panel testing. Figure 5 is a diagram showing examples of FFPE blocks (specimens) and slide specimens. Figure 6 is a diagram showing an example of a slide specimen set. Figure 7 is a diagram showing an example of a stained slide specimen with the first target region marked.

[0037] When a clinician decides to perform a gene panel test, gene panel testing method S1 is executed.

[0038] In step S2, the laboratory technician prepares slide specimens to be used for selecting FFPE blocks (samples). For example, the laboratory technician may prepare one slide specimen for each FFPE block. The FFPE blocks and slide specimens may have been prepared at one or more past time points and may include multiple FFPE blocks and slide specimens prepared from different samples. In the example shown in Figure 5, corresponding slide specimens 43 to 45 are prepared for FFPE blocks 40 to 42, respectively.

[0039] In step S3, the pathologist examines the slide specimen prepared in step S2. Then, in step S4, the pathologist selects the FFPE block (specimen) to be used for gene panel testing. In the example shown in Figure 5, for example, FFPE block 42 may be selected.

[0040] In step S5, the medical technologist prepares a slide specimen set from the FFPE block (specimen) selected in step S4. For example, the medical technologist sections the FFPE block and prepares slide specimens from each section. Then, the slide specimen of the top (first) section and the slide specimen of the bottom (last) section are stained, such as with HE staining, to prepare stained slide specimens. Alternatively, only one of the slide specimens of the top or bottom section may be stained. Slide specimens that are not stained become unstained slide specimens. In the example shown in Figure 6, the slide specimen set 50 is prepared from the FFPE block 42 and includes a first stained slide specimen 51, a second stained slide specimen 52, and one or more unstained slide specimens 53.

[0041] In step S6, the pathologist marks the first target area on the stained slide specimen. In the example shown in Figure 7, the first stained slide specimen 51 has the first target area 51a marked, and the second stained slide specimen 52 has the target area 52a marked.

[0042] In step S10A, the pathologist uses the slide specimen confirmation support system 1A or slide specimen confirmation support device 100A, described later, to confirm the stained slide specimen in which the first target area has been marked.

[0043] In step S7, the pathologist registers the data related to the slide specimen set confirmed in step S10A on a dedicated website for requesting gene panel testing from a specialized institution, and requests the testing.

[0044] In step S8, a gene panel test is performed at a specialized institution. In step S9, a clinician determines the drug to be used by referring to the results of the gene panel test.

[0045] (Configuration of the Slide Specimen Confirmation Support System) The configuration of the slide specimen confirmation support system 1A will be described with reference to FIG. 8. FIG. 8 is a block diagram showing an example of the configuration of the slide specimen confirmation support system 1A. The slide specimen confirmation support system 1A includes a terminal 2 and a server 3, and the terminal 2 and the server 3 are communicably connected. In addition, an imaging device 4 is connected to the server 3. A printing device 5 is connected to the terminal 2.

[0046] The terminal 2 includes a communication unit (communication means) 21, a display unit (display means) 22, an input unit (input means) 23, a first output unit 12, a specifying unit 13, a second output unit 14, a first generation unit 15, a third output unit (third output means) 24, a second generation unit (second generation means) 25, a first presentation unit (first presentation means) 26, and a second presentation unit (second presentation means) 27. The server 3 includes an image acquisition unit 11, an estimation unit (estimation means) 31, and a communication unit (communication means) 32.

[0047] In one example, the imaging device 4 images the first stained slide specimen 51, the second stained slide specimen 52, the unstained slide specimen 53, etc., and acquires images thereof. The image acquisition unit 11 acquires an image of the first stained slide specimen 51 from the imaging device 4 in one example.

[0048] The estimation unit 31 estimates the tumor cell content ratio for each position of the first stained slide specimen 51 based on the image of the first stained slide specimen 51. The tumor cell content ratio for each position of the stained slide specimen is intended to be the tumor cell content ratio at each of a plurality of positions of the stained slide specimen. For example, the stained slide specimen may be divided into a plurality of sections, and the ratio of tumor cells among the cells included in each section may be shown.

[0049] The estimation method for determining the tumor cell content ratio at each position of the first stained slide specimen 51 in the estimation unit 31 is not particularly limited. For example, as described above, the stained slide specimen may be divided into multiple sections, and the number of tumor cells and normal cells in each section may be calculated using image recognition technology, and the proportion of tumor cells in each section may be calculated.

[0050] In this case, the estimation unit 31 may use image recognition technology to detect the marking of the first target region 51a in the image of the first stained slide specimen 51 and identify the position of the first target region 51a. Alternatively, the estimation unit 31 may estimate the tumor cell content ratio by considering the position of the detected marking of the first target region 51a.

[0051] In one example, the communication unit 32 of the server 3 transmits to the terminal 2 the image of the first stained slide specimen 51 acquired by the image acquisition unit 11, the number of tumor cells, the number of normal cells, and the tumor cell content ratio for each position of the first stained slide specimen 51 estimated by the estimation unit 31, and the position of the first target region 51a detected by the estimation unit 31.

[0052] In one example, the communication unit 21 of terminal 2 obtains from server 3 an image of the first stained slide specimen 51, the estimated number of tumor cells, the number of normal cells, and the percentage of tumor cells at each location on the first stained slide specimen 51, and the location of the first target region 51a.

[0053] The display unit 22 is, for example, a display, and displays arbitrary information. The input unit 23 is, for example, a keyboard, mouse, touchpad, touch panel, stylus, etc., and accepts input from the user.

[0054] Figure 9 shows an example of the display on the display unit 22. In the example shown in Figure 9, the display unit 22 is a touch panel and also performs some of the functions of the input unit 23. The input unit 23 is composed of a touch panel and a stylus pen.

[0055] The third output unit 24 displays a processed image on the display unit 22, which is an image of the first stained slide specimen 51, showing the results of artificial intelligence estimating the tumor cell content ratio at each position of the first stained slide specimen 51 based on the image of the first stained slide specimen 51.

[0056] As shown in Figure 9, in one example, the third output unit 24 generates a color map image 63 that shows the estimated results of the tumor cell content ratio for each position of the first stained slide specimen 51, estimated by the estimation unit 31 (artificial intelligence) based on the image of the stained slide specimen 51, by color-coding each tile. The display unit 22 may then display a processed image in which the color map image 63 is superimposed on the image of the first stained slide specimen 51. In this case, by setting the transparency of the color map image 63, the image of the first stained slide specimen 51 can be viewed by the user.

[0057] Furthermore, as shown in Figure 10, in another example, the third output unit 24 may generate a gradient image 64 that shows the estimated results of the tumor cell content ratio for each position of the first stained slide specimen 51, estimated by the estimation unit 31 (artificial intelligence) based on the image of the stained slide specimen 51, using color gradations, and display the processed image, in which the gradient image 64 is superimposed on the image of the first stained slide specimen 51, on the display unit 22. In addition, by setting the transparency of the gradient image 64, the image of the first stained slide specimen 51 can be viewed by the user.

[0058] Furthermore, as shown in Figures 9 and 10, the display unit 22 may also display an image showing the first target area 51a and an image showing the second target area 51b superimposed on a color map image 63 or a gradient image 64.

[0059] In one example, the third output unit 24 may display a processed image on the display unit 22, which is an image of the first stained slide specimen 51 processed to show the estimated number of tumor cells at each position of the first stained slide specimen 51. In another example, the third output unit 24 may be switchable between showing the estimated percentage of tumor cells and showing the estimated number of tumor cells.

[0060] The first output unit 12 outputs an estimated result of the tumor cell content ratio of the first target region 51a based on the image of the first stained slide specimen 51. In one example, the first output unit 12 may use the estimated results of the tumor cell content ratio for each position of the first stained slide specimen 51 received from the server 3 and the position of the first target region 51a to calculate the tumor cell content ratio of the first target region 51a and display it on the display unit 22.

[0061] The first output unit 12 may further output an estimated result for the number of tumor cells in the first target region 51a based on the image of the first stained slide specimen 51. In one example, the first output unit 12 may calculate the number of tumor cells in the first target region 51a using the estimated number of tumor cells at each location of the first stained slide specimen 51 received from the server 3, similar to the tumor cell content ratio, and display it on the display unit 22. In addition to the number of tumor cells in the first target region 51a, the display unit 22 may also display the number of normal cells in the first target region 51a together.

[0062] The information display 61 in Figure 9 is an example of the output result of the first output unit 12. "TC%" indicates the percentage of tumor cells, and "#Tumor / #Non-tumor" indicates the number of tumor cells and the number of normal cells. As shown in Figure 9, the output result of the first output unit 12 may be superimposed on the image of the first stained slide specimen 51 and displayed on the display unit 22.

[0063] The second display unit 27 determines whether the requirements for gene panel testing are met in several situations, and if it determines that the requirements are not met, it displays this to the user. In one example, the second display unit 27 may display the alert in text on the display unit 22. In another example, the second display unit 27 may mark the alert on the test list to prompt the user to view it.

[0064] In one example, the second display unit 27 may determine whether the first target area 51a meets the requirements necessary for gene panel testing. In one example, the requirement for the first target area 51a may be that the tumor cell content is at or above a predetermined percentage. In another example, the requirement for the first target area 51a may be that the tumor cell content is at or above a predetermined percentage, and the number of tumor cells is at or above a predetermined number. In yet another example, the requirement for the first target area 51a may be that the tumor cell content is at or above a predetermined percentage, and the number of tumor cells may be the required number of tumor cells per slide, which is determined by the number of usable slides determined by the remaining amount of FFPE block (sample). The second display unit 27 may display an alert on the display unit 22 if the first target area 51a does not meet these requirements.

[0065] The identification unit 13 identifies the second target region 51b on the first stained slide specimen 51 either in response to user input or automatically. However, if there is no user input or if the first target region 51a meets the requirements for gene panel testing, it is not necessary to identify the second target region 51b.

[0066] As an example, as shown in Figure 9, the user may mark the second target area 51b on the image of the first stained slide specimen 51 via the input unit 23.

[0067] As another example, the identification unit 13 may identify a second target region 51b based on the estimated tumor cell content ratio for each position in the first stained slide specimen 51. For example, the identification unit 13 may refer to the estimated tumor cell content ratio for each position in the first stained slide specimen 51 and identify a region where the tumor cell content ratio exceeds the value required for gene panel testing as the second target region 51b.

[0068] At this time, the identification unit 13 may further identify the second target region 51b based on the optimization settings specified by the user. Examples of the optimization settings include the size of the second target region 51b, the required number of tumor cells, the remaining amount of FFPE block (sample) used to prepare the first stained slide specimen 51, and at least one of the following: the tumor cell content ratio or the number of slide specimens used.

[0069] For example, the identification unit 13 may identify regions within the size of the designated second target region 51b where the tumor cell content exceeds the value required for gene panel testing, based on the estimated tumor cell content for each position in the first stained slide specimen 51.

[0070] As another example, the identification unit 13 may identify regions where the tumor cell content exceeds the value required for gene panel testing, including the specified required number of tumor cells, based on the estimated number of tumor cells and tumor cell content for each position in the first stained slide specimen 51.

[0071] As another example, the identification unit 13 may identify regions where the tumor cell content exceeds the value required for gene panel testing, based on the estimated number of tumor cells and tumor cell content for each position on the first stained slide specimen 51, including the required number of tumor cells per slide, which is determined by the number of usable slides, which is determined by the remaining amount of FFPE block (sample) used to prepare the designated first stained slide specimen 51.

[0072] As another example, if the specification unit 13 is specified to prioritize the tumor cell content, it may specify the second target area 51b so that the tumor cell content is as high as possible. In this case, the size of the second target area 51b will be smaller. Alternatively, if the specification unit 13 is specified to prioritize the number of slide specimens used, it may specify the second target area 51b so that the number of tumor cells is as high as possible. In this case, the size of the second target area 51b will be larger.

[0073] The identification unit 13 may also correct the position of the automatically identified second target area 51b in response to user input.

[0074] Furthermore, if the identification unit 13 is unable to identify the second target area 51b, the first presentation unit 26 may, for example, suggest to the user a change in the FFPE block (specimen) used to prepare the slide specimen. In addition, if the remaining amount of stored FFPE blocks is digitally managed, the first presentation unit 26 may also suggest to the user which FFPE block to select from the stored FFPE blocks.

[0075] As another example, if the identification unit 13 fails to identify the second target region 51b, the second presentation unit 27 may present an alert to the user indicating that the first stained slide specimen 51 itself does not meet the requirements for gene panel testing. The first presentation unit 26 and the second presentation unit 27 may present information, for example, by displaying text on the display unit 22.

[0076] The second output unit 14 outputs an estimated result of the tumor cell content ratio of the second target region 51b based on the image of the first stained slide specimen 51. In one example, the second output unit 14 may calculate the tumor cell content ratio of the second target region 51b using the estimated results of the tumor cell content ratio for each position of the first stained slide specimen 51 received from the server 3 and the position of the second target region 51b identified by the identification unit 13, and display it on the display unit 22.

[0077] The second output unit 14 may further output an estimated result for the number of tumor cells in the second target region 51b based on the image of the first stained slide specimen 51. In one example, the second output unit 14 may calculate the number of tumor cells in the second target region 51b using the estimated number of tumor cells at each location of the first stained slide specimen 51 received from the server 3, similar to the tumor cell content ratio, and display it on the display unit 22. In addition to the number of tumor cells in the second target region 51b, the display unit 22 may also display the number of normal cells in the second target region 51b together.

[0078] The information display 62 in Figure 9 is an example of the output result of the second output unit 14. "TC%" indicates the tumor cell percentage, and "#Tumor / #Non-tumor" indicates the number of tumor cells and the number of normal cells. As shown in Figure 9, the output result of the second output unit 14 may be superimposed on the image of the first stained slide specimen 51 and displayed on the display unit 22.

[0079] In one example, the second display unit 27 may determine whether the second target region 51b meets the requirements necessary for gene panel testing. In one example, the requirements for the second target region 51b may be the same as the requirements for the first target region 51a described above. The second display unit 27 may display an alert on the display unit 22 if the second target region 51b does not meet the requirements.

[0080] The first generation unit 15 generates target area change information indicating the use of the second target area 51b in response to input from the user. The user may, for example, instruct via the input unit 23 to use the second target area 51b if the second target area 51b is preferred over the first target area 51a.

[0081] Alternatively, the user may instruct the system to use the first target area 51a via the input unit 23. In this case, the first generation unit 15 does not generate target area change information.

[0082] In one example, the target area change information is marking information for marking the second target area 51b on the first stained slide specimen 51. For example, the printing device 5 may print the second target area 51b on the first stained slide specimen 51 based on the marking information. The marking information may also include size information indicating the size of the slide specimen.

[0083] In one example, the printing device 5 may print a figure indicating the second target area 51b onto a medium for transferring it to the first stained slide specimen 51. The medium may be, for example, paper, and in one example, transfer paper such as carbon paper.

[0084] In another example, the printing device 5 may print a figure indicating the second target area 51b directly onto the first stained slide specimen 51 using inkjet printing.

[0085] As described above, as shown in Figure 9, the second target region 51b can be marked on the first stained slide specimen 51, and a sample can be cut out from the appropriate region in gene panel testing.

[0086] In another example, the second target region 51b was not marked on the first stained slide specimen 51, and in step S7, the target region change information was submitted to a dedicated site for requesting gene panel testing from a specialized institution.

[0087] Furthermore, in one example, the first generation unit 15 may generate marking information for marking a target area on the unstained slide specimen 53.

[0088] In other words, as described above, a slide specimen set including a first stained slide specimen 51 is prepared from the same FFPE block (sample), and the slide specimen set further includes a second stained slide specimen 52 and one or more unstained slide specimens 53, the one or more unstained slide specimens 53 being slide specimens of one or more sections located between the section of the first stained slide specimen 51 and the section of the second stained slide specimen 52 in the FFPE block.

[0089] At this time, the first generation unit 15 may further generate marking information for unstained slides to mark the target areas of one or more unstained slide specimens 53 based on the position of the target area 52a of the second stained slide specimen 52 and the position of the target area of ​​the first stained slide specimen 51, and to mark the target areas on each unstained slide specimen 53. The target area of ​​the first stained slide specimen 51 is either the first target area 51a or the second target area 51b. If the user instructs to use the first target area 51a, it is the first target area 51a, and if the user instructs to use the second target area 51b, it is the second stained slide specimen 51b. In one example, the first generation unit 15 may identify the target areas of one or more unstained slide specimens 53 by linearly interpolating the position of the target area 52a of the second stained slide specimen 52 and the position of the target area of ​​the first stained slide specimen 51.

[0090] This allows, for example, the printing device 5 to mark the target area of ​​one or more unstained slide specimens 53, enabling the appropriate separation of samples from the slide specimen set in gene panel testing.

[0091] In one example, the first generation unit 15 may generate target area change information, or the user may instruct the first target area 51a to be used, in which case evidence information indicating that the first stained slide specimen 51 has been confirmed may be generated using the slide specimen confirmation support system 1A. Note that the first generation unit 15 generating target area change information is equivalent to the user instructing the second target area 51b to be used.

[0092] The evidence information may, for example, be a data file having a specific extension, which is registered in step S7 on a dedicated site for requesting gene panel testing from a specialized institution. The evidence information may further include a report on the verification of the first stained slide specimen 51 using the slide specimen verification support system 1A (for example, the percentage of tumor cells in each target region).

[0093] By registering the evidence information, it is possible to prevent inadequately verified slide specimen sets from being sent to specialized institutions, thereby reducing the failure of orphan panel examinations caused by inappropriate slide specimen sets.

[0094] In the above embodiment, the estimation unit 31 of the server 3 calculates the number of tumor cells, the number of normal cells, and the tumor cell content ratio for each position of the first stained slide specimen 51, as well as the position of the first target region 51a, and the first output unit 12 and second output unit 14 of the terminal 2 calculate the tumor cell content ratio and the number of tumor cells in the first target region 51a or the second target region 51b. However, the division of computational processing between the server 3 and the terminal 2 is not limited to this configuration, and it is sufficient as long as the necessary calculations are performed for the slide specimen verification support system 1A as a whole.

[0095] (Effects of the slide specimen confirmation support system) As described above, the slide specimen confirmation support system 1A employs a configuration in which the target region change information may be marking information for marking the second target region 51b on the first stained slide specimen 51. Therefore, in addition to the effects of the slide specimen confirmation support system 1, the slide specimen confirmation support system 1A provides the effect of being able to suitably perform gene panel testing by marking the second target region 51b on the first stained slide specimen 51 as needed.

[0096] As described above, the slide specimen confirmation support system 1A may further include a printing device 5 that prints transfer paper on which a figure indicating the second target area 51b is transferred to the first stained slide specimen 51 based on the marking information. Therefore, in addition to the effects of the slide specimen confirmation support system 1, the slide specimen confirmation support system 1A provides the effect of successfully marking the second target area on the first stained slide specimen 51.

[0097] As described above, the slide specimen confirmation support system 1A may further include a third output unit 24 that outputs a processed image of the first stained slide specimen 51, which is processed to show the results of artificial intelligence estimating the tumor cell content ratio at each position of the first stained slide specimen 51 based on the image of the first stained slide specimen 51. Therefore, the slide specimen confirmation support system 1A has the effect of allowing the user to easily grasp the tumor cell content ratio at each position and to easily understand whether the first target area 51a is appropriate and where the second target area 51b should be set.

[0098] As described above, the slide specimen verification support system 1A may further include a second generation unit 25 that generates evidence information indicating that the first stained slide specimen 51 has been verified using the slide specimen verification support system 1A, in response to the first generation unit 15 generating target area change information or the user instructing to use the first target area 51a. Therefore, the slide specimen verification support system 1A has the effect of being able to assure testing laboratories and others that the first stained slide specimen 51 has been verified.

[0099] As described above, the slide specimen confirmation support system 1A is configured such that the first output unit 12 further outputs the estimated number of tumor cells in the first target region 51a based on the image of the first stained slide specimen 51, and the second output unit 14 further outputs the estimated number of tumor cells in the second target region 51b based on the same image. Therefore, the slide specimen confirmation support system 1A has the effect of allowing the user to easily grasp the number of tumor cells in addition to the tumor cell content.

[0100] As described above, the slide specimen confirmation support system 1A employs a configuration in which the identification unit 13 may identify the second target region 51b based on the estimation result of the tumor cell content ratio at each position of the first stained slide specimen 51, based on the image of the first stained slide specimen 51. Therefore, the slide specimen confirmation support system 1A has the effect of automatically identifying an appropriate second target region 51b.

[0101] As described above, in the slide specimen confirmation support system 1A, the identification unit 13 further identifies the second target area 51b based on the optimization settings specified by the user, and the optimization settings may be configured to prioritize at least one of the following: the size of the second target area 51b, the required number of tumor cells, the remaining amount of the sample used to prepare the first stained slide specimen 51, and the tumor cell content ratio and the number of slide specimens used. Therefore, the slide specimen confirmation support system 1A has the effect of being able to identify an appropriate second target area 51b according to the user's purpose.

[0102] As described above, the slide specimen confirmation support system 1A may further include a first presentation unit 26 that presents the user with a suggestion to change the specimen for which the slide specimen is to be prepared when the identification unit 13 is unable to identify the second target area 51b. Therefore, the slide specimen confirmation support system 1A has the effect of being able to present the user with guidance for selecting an appropriate slide specimen set.

[0103] As described above, the slide specimen confirmation support system 1A may further include a second presentation unit 27 that determines whether one or more of the first target area 51a, the second target area 51b, and the first stained slide specimen 51 meet the requirements necessary for gene panel testing, and if it is determined that the requirements are not met, it presents this fact to the user. Therefore, the slide specimen confirmation support system 1A has the effect of drawing the user's attention when the requirements necessary for gene panel testing are not met.

[0104] As described above, in the slide specimen confirmation support system 1A, a slide specimen set including a first stained slide specimen 51 is prepared from the same sample. The slide specimen set further includes a second stained slide specimen 52 and one or more unstained slide specimens 53. The one or more unstained slide specimens 53 are slide specimens of one or more sections located between the section of the first stained slide specimen 51 and the section of the second stained slide specimen 52 in the sample. The first generation unit 15 may further generate marking information for unstained slides to mark the target region of each of the one or more unstained slide specimens 53 based on the position of the target region of the second stained slide specimen 52 and the position of the first target region 51a or the second target region 51b of the first stained slide specimen 51, and to mark the target region on each unstained slide specimen 53. Therefore, the slide specimen confirmation support system 1A has the effect of being able to suitably separate the sample from the unstained slide specimen in gene panel testing.

[0105] (Other configuration examples) In one example, the slide specimen confirmation support system 1A further comprises a result acquisition unit (result acquisition means) that acquires the test results of a gene panel test, and the test results include the tumor cell content ratio of the first target region 51a or the second target region 51b, and the first output unit 12 or the second output unit 14 may display the tumor cell content ratio of the first target region 51a or the second target region 51b indicated by the test results together with the estimated result. This allows the user to compare the estimated result of the tumor cell content ratio by the slide specimen confirmation support system 1A with the actual test result and confirm the accuracy of the slide specimen confirmation support system 1A.

[0106] In one example, the image acquisition unit 11 may further acquire images of one or more unstained slide specimens 53 included in the slide specimen set, which includes the first stained slide specimen 51. At this time, the estimation unit 31 may use a trained model, which has been trained using a set of images of unstained slide specimens and stained slide specimens as training data, to generate a pseudo-stained slide image from the image of one or more unstained slide specimens 53 by image processing. The estimation unit 31 may then use the pseudo-stained slide image to estimate the tumor cell content ratio for each location in one or more unstained slide specimens 53. The first output unit 12 may then further output the estimated result of the tumor cell content ratio for the region corresponding to the first target region 51a in one or more unstained slide specimens 53, based on the estimation result of the estimation unit 31. The second output unit 14 may further output the estimated result of the tumor cell content ratio for the region corresponding to the second target region 51b in one or more unstained slide specimens 53, based on the estimation result of the estimation unit 31. This allows users to check the estimated percentage of tumor cells in unstained slide specimens, effectively verifying the suitability of the slide specimen set.

[0107] Although the above description has focused on a configuration with a single terminal 2, this embodiment is not limited to this configuration. The system may be configured with multiple terminals. Figure 12 shows a schematic configuration of a slide specimen confirmation support system 1B equipped with multiple terminals 2.

[0108] The slide specimen verification support system 1B includes multiple terminals 2 used by different users, each of which may have at least a first output unit 12 and a second output unit 14, preferably having a configuration equivalent to that of the terminals 2 of the slide specimen verification support system 1A. This allows multiple users to verify the suitability of the first stained slide specimen 51.

[0109] Furthermore, although the above describes a system comprising terminal 2 and server 3, this embodiment is not limited to this. It may also be configured as a device comprising all the parts of the system. Figure 13 is a diagram showing the schematic configuration of a slide specimen confirmation support device 100A comprising the parts of slide specimen confirmation support system 1A. The slide specimen confirmation support device 100A comprises an imaging device 4, an image acquisition unit 11, an estimation unit 31, a display unit 22, an input unit 23, a first output unit 12, a identification unit 13, a second output unit 14, a first generation unit 15, a third output unit 24, a second generation unit 25, a first presentation unit 26, a second presentation unit 27, and a printing device 5. Note that the slide specimen confirmation support device 100A does not include communication units 21 and 31 for communication between terminal 2 and server 3. The slide specimen confirmation support device 100A also has the same functions as the slide specimen confirmation support system 1A.

[0110] [Example of implementation by software] Some or all of the functions of the slide specimen verification support systems 1, 1A, and 1B (hereinafter also referred to as "the above systems") and the slide specimen verification support devices 100 and 100A (hereinafter also referred to as "the above devices") may be implemented by hardware such as integrated circuits (IC chips) or by software.

[0111] In the latter case, each of the above systems and devices is implemented, for example, by a computer that executes instructions for a program, which is software that realizes each function. An example of such a computer (hereinafter referred to as computer C) is shown in Figure 14. Figure 14 is a block diagram showing the hardware configuration of computer C, which functions as each of the above systems or devices.

[0112] Computer C comprises at least one processor C1 and at least one memory C2. Memory C2 stores a program P for operating Computer C as one of the above-mentioned devices. In Computer C, the processor C1 reads and executes the program P from memory C2, thereby realizing each of the above-mentioned systems or devices.

[0113] For processor C1, for example, a CPU (Central Processing Unit), GPU (Graphic Processing Unit), DSP (Digital Signal Processor), MPU (Micro Processing Unit), FPU (Floating Point Number Processing Unit), PPU (Physics Processing Unit), TPU (Tensor Processing Unit), quantum processor, microcontroller, or a combination thereof can be used. For memory C2, for example, flash memory, HDD (Hard Disk Drive), SSD (Solid State Drive), or a combination thereof can be used.

[0114] Furthermore, computer C may also be equipped with RAM (Random Access Memory) for loading program P at runtime and for temporarily storing various data. Computer C may also be equipped with a communication interface for sending and receiving data with other devices. Furthermore, computer C may also be equipped with an input / output interface for connecting input / output devices such as a keyboard, mouse, display, and printer.

[0115] Furthermore, program P can be recorded on a non-temporary, tangible recording medium M that is readable by computer C. Such recording medium M can include, for example, tape, disk, card, semiconductor memory, or programmable logic circuitry. Computer C can acquire program P via such recording medium M. Program P can also be transmitted via a transmission medium. Such transmission mediums can include, for example, a communication network or broadcast waves. Computer C can also acquire program P via such transmission medium.

[0116] Furthermore, each of the above functions of each system and each of the above devices may be implemented by a single processor in a single computer, by multiple processors in a single computer working together, or by multiple processors in each of multiple computers working together. In addition, the programs for implementing each of the above functions in each of the above systems or devices may be stored in a single memory in a single computer, distributed and stored in multiple memories in a single computer, or distributed and stored in multiple memories in each of multiple computers.

[0117] [Addendum 1] This disclosure includes the technologies described in the following addendums. However, the present invention is not limited to the technologies described in the following addendums, and various modifications are possible within the scope of the claims. (Addendum 1) A slide specimen confirmation support system comprising: an image acquisition means for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target area is marked by a physician; a first output means for outputting an estimated result based on the image regarding the tumor cell content of the first target area; a identification means for identifying a second target area on the first stained slide specimen; a second output means for outputting an estimated result based on the image regarding the tumor cell content of the second target area; and a first generation means for generating target area change information indicating the use of the second target area in response to instructions from a user.

[0118] (Note 2) The slide specimen confirmation support system described in Note 1, wherein the target area change information is marking information for marking the second target area on the first stained slide specimen.

[0119] (Note 3) The slide specimen confirmation support system according to Note 2, further comprising: printing means for printing transfer paper on which a figure indicating the second target area is transferred to the first stained slide specimen based on the marking information.

[0120] (Appendix 4) The slide specimen confirmation support system according to any one of Appendix 1 to 3, further comprising: a third output means for outputting a processed image obtained by processing the image so as to show the results of artificial intelligence estimating the tumor cell content ratio for each position of the first stained slide specimen based on the image.

[0121] (Note 5) The slide specimen confirmation support system according to any one of Notes 1 to 4, further comprising: a second generation means for generating evidence information indicating that the first stained slide specimen has been confirmed using the slide specimen confirmation support system in response to the first generation means generating the target area change information or the user instructing to use the first target area.

[0122] (Note 6) The slide specimen confirmation support system according to any one of Notes 1 to 5, wherein the first output means further outputs the estimated result of the number of tumor cells in the first target area based on the image, and the second output means further outputs the estimated result of the number of tumor cells in the second target area based on the image.

[0123] (Note 7) The slide specimen confirmation support system according to any one of Notes 1 to 6, wherein the identification means identifies the second target region based on the estimated results of the tumor cell content ratio at each position of the first stained slide specimen, based on the image.

[0124] (Note 8) The slide specimen confirmation support system according to Note 7, wherein the identifying means further identifies the second target area based on the optimization settings specified by the user, the optimization settings being at least one of the following priorities: the size of the second target area, the required number of tumor cells, the remaining amount of the sample used to prepare the first stained slide specimen, and the tumor cell content and the number of slide specimens used.

[0125] (Note 9) The slide specimen confirmation support system according to Note 7 or 8, further comprising: a first presentation means for presenting to the user a suggestion to change the specimen for which the slide specimen is to be prepared when the identification means fails to identify the second target area.

[0126] (Note 10) A slide specimen confirmation support system according to any one of Notes 1 to 9, further comprising: a second presentation means for determining whether one or more of the first target area, the second target area, and the first stained slide specimen meet the requirements necessary for the gene panel test, and if it is determined that the requirements are not met, presenting that fact to the user.

[0127] (Note 11) A slide specimen confirmation support system according to any one of Notes 1 to 10, comprising a plurality of terminals used by different users, each of which is equipped with the first output means and the second output means.

[0128] (Note 12) A slide specimen confirmation support system according to any one of Notes 1 to 11, wherein a slide specimen set is prepared from the same sample, the slide specimen set further includes a second stained slide specimen and one or more unstained slide specimens, the one or more unstained slide specimens being slide specimens of one or more sections located between the section of the first stained slide specimen and the section of the second stained slide specimen in the sample, and the first generating means identifies each of the one or more unstained slide specimens based on the position of the target region of the second stained slide specimen and the position of the first or second target region of the first stained slide specimen, and further generates marking information for unstained slides for marking the target region on each unstained slide specimen.

[0129] (Note 13) A slide specimen confirmation support device comprising: an image acquisition means for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target area has been marked by a physician; a first output means for outputting an estimated result based on the image regarding the tumor cell content of the first target area; an identification means for identifying a second target area on the first stained slide specimen; a second output means for outputting an estimated result based on the image regarding the tumor cell content of the second target area; and a first generation means for generating target area change information indicating the use of the second target area in response to instructions from the user.

[0130] (Note 14) A slide specimen confirmation support method comprising: acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target region has been marked by a physician; outputting an estimated result based on the image regarding the tumor cell content of the first target region; identifying a second target region on the first stained slide specimen; outputting an estimated result based on the image regarding the tumor cell content of the second target region; and generating target region change information indicating the use of the second target region in response to instructions from the user.

[0131] (Note 15) A slide specimen confirmation support program that causes at least one processor to execute: an image acquisition process that acquires an image of a first stained slide specimen for gene panel testing, wherein a first target region is marked by a physician; a first output process that outputs an estimated result based on the image regarding the tumor cell content of the first target region; a identification process that identifies a second target region on the first stained slide specimen; a second output process that outputs an estimated result based on the image regarding the tumor cell content of the second target region; and a first generation process that generates target region change information indicating the use of the second target region in response to instructions from the user.

[0132] [Addendum 2] This disclosure includes the technologies described in the following addendums. However, the present invention is not limited to the technologies described in the following addendums, and various modifications are possible within the scope of the claims.

[0133] (Note 1) A slide specimen confirmation support system comprising at least one processor, the at least one processor performing: an image acquisition process to acquire an image of a first stained slide specimen for gene panel testing, the first stained slide specimen having a first target region marked by a physician; a first output process to output an estimated result based on the image regarding the tumor cell content of the first target region; a identification process to identify a second target region on the first stained slide specimen; a second output process to output an estimated result based on the image regarding the tumor cell content of the second target region; and a first generation process to generate target region change information indicating the use of the second target region in response to instructions from the user.

[0134] (Note 2) The slide specimen confirmation support system described in Note 1, wherein the target area change information is marking information for marking the second target area on the first stained slide specimen.

[0135] (Note 3) The slide specimen verification support system according to Note 2, wherein the at least one processor further performs a printing process of printing a transfer paper on which a figure indicating the second target area is transferred to the first stained slide specimen based on the marking information.

[0136] (Note 4) The slide specimen verification support system according to Note 1, wherein the at least one processor further performs a third output process which outputs a processed image obtained by processing the image so as to show the results of artificial intelligence estimating the tumor cell content ratio for each position of the first stained slide specimen based on the image.

[0137] (Note 5) The slide specimen confirmation support system according to Note 1, wherein the at least one processor further executes a second generation process which generates evidence information indicating that the first stained slide specimen has been confirmed using the slide specimen confirmation support system, in response to the fact that the target area change information has been generated in the first generation process or that the user has instructed to use the first target area.

[0138] (Note 6) The slide specimen verification support system according to Note 1, wherein the at least one processor further outputs an estimated result of the number of tumor cells in the first target region based on the image in the first output processing, and further outputs an estimated result of the number of tumor cells in the second target region based on the image in the second output processing.

[0139] (Note 7) The slide specimen verification support system according to Note 1, wherein the at least one processor identifies the second target region based on the estimated results of the tumor cell content ratio at each position of the first stained slide specimen, based on the image, in the specific processing.

[0140] (Note 8) The slide specimen verification support system according to Note 7, wherein the at least one processor further identifies the second target area based on an optimization setting specified by the user in the specific processing, the optimization setting being at least one of the following priorities: the size of the second target area, the required number of tumor cells, the remaining amount of the sample used to prepare the first stained slide specimen, and the tumor cell content ratio and the number of slide specimens used.

[0141] (Note 9) The slide specimen confirmation support system according to Note 7, wherein the at least one processor further performs a first presentation process that presents the user with a suggestion to change the specimen for which the slide specimen is to be prepared when the second target area could not be identified in the specific process.

[0142] (Note 10) The slide specimen verification support system according to Note 1, wherein the at least one processor further performs a second presentation process, in which it determines whether one or more of the first target region, the second target region, and the first stained slide specimen meet the requirements necessary for the gene panel test, and if it determines that the requirements are not met, it presents that fact to the user.

[0143] (Note 11) The slide specimen verification support system according to Note 1, comprising a plurality of terminals used by different users, each of which performs the first output processing and the second output processing.

[0144] (Note 12) A slide specimen set is prepared from the same sample, the slide specimen set further includes a second stained slide specimen and one or more unstained slide specimens, the one or more unstained slide specimens being slide specimens of one or more sections located between the section of the first stained slide specimen and the section of the second stained slide specimen in the sample, and the at least one processor, in a first generation process, identifies each of the one or more unstained slide specimens based on the position of the target region of the second stained slide specimen and the position of the first or second target region of the first stained slide specimen, and further generates marking information for unstained slides for marking the target region on each unstained slide specimen, the slide specimen confirmation support system according to Note 1.

[0145] (Note 13) A slide specimen confirmation support device comprising at least one processor, the at least one processor performing: an image acquisition process to acquire an image of a first stained slide specimen for gene panel testing, wherein a first target region is marked by a physician; a first output process to output an estimated result based on the image regarding the tumor cell content of the first target region; a identification process to identify a second target region on the first stained slide specimen; a second output process to output an estimated result based on the image regarding the tumor cell content of the second target region; and a first generation process to generate target region change information indicating the use of the second target region in response to instructions from the user.

[0146] 1, 1A, 1B ... Slide specimen confirmation support system 100, 100A ... Slide specimen confirmation support device 11 ... Image acquisition unit 12 ... First output unit 13 ... Identification unit 14 ... Second output unit 15 ... First generation unit 22 ... Display unit 23 ... Input unit 24 ... Third output unit 25 ... Second generation unit 26 ... First presentation unit 27 ... Second presentation unit 31 ... Estimation unit 51 ... First stained slide specimen 52 ... Second stained slide specimen 53 ... Unstained slide specimen 51a ... First target area 51b ... Second target area

Claims

1. A slide specimen confirmation support system comprising: an image acquisition means for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target region has been marked by a physician; a first output means for outputting an estimated result based on the image regarding the tumor cell content of the first target region; an identification means for identifying a second target region on the first stained slide specimen; a second output means for outputting an estimated result based on the image regarding the tumor cell content of the second target region; and a first generation means for generating target region change information indicating the use of the second target region in response to instructions from the user.

2. The slide specimen confirmation support system according to claim 1, wherein the target area change information is marking information for marking the second target area on the first stained slide specimen.

3. The slide specimen confirmation support system according to claim 2, further comprising: printing means for printing a figure indicating the second target area onto a medium for transferring the figure onto the first stained slide specimen based on the marking information.

4. The slide specimen confirmation support system according to any one of claims 1 to 3, further comprising: a third output means for outputting a processed image obtained by processing the image so as to show the results of artificial intelligence estimating the tumor cell content ratio for each position of the first stained slide specimen based on the image.

5. The slide specimen confirmation support system according to any one of claims 1 to 4, further comprising: a second generation means for generating evidence information indicating that the first stained slide specimen has been confirmed using the slide specimen confirmation support system in response to the first generation means generating the target area change information or the user instructing to use the first target area.

6. The slide specimen confirmation support system according to any one of claims 1 to 5, wherein the first output means further outputs the estimated result of the number of tumor cells in the first target area based on the image, and the second output means further outputs the estimated result of the number of tumor cells in the second target area based on the image.

7. The slide specimen confirmation support system according to any one of claims 1 to 6, wherein the identifying means identifies the second target region based on the estimated results of the tumor cell content ratio at each position of the first stained slide specimen, based on the image.

8. The slide specimen verification support system according to claim 7, wherein the identifying means further identifies the second target area based on optimization settings specified by the user, the optimization settings being at least one of the following priorities: the size of the second target area, the required number of tumor cells, the remaining amount of the sample used to prepare the first stained slide specimen, and the tumor cell content and the number of slide specimens used.

9. The slide specimen confirmation support system according to claim 7 or 8, further comprising: a first presentation means for presenting to the user a suggestion to change the specimen for which the slide specimen is prepared when the identification means fails to identify the second target area.

10. The slide specimen confirmation support system according to any one of claims 1 to 9, further comprising: a second presentation means for determining whether one or more of the first target region, the second target region, and the first stained slide specimen meet the requirements necessary for the gene panel test, and for indicating to the user if it is determined that the requirements are not met.

11. The slide specimen confirmation support system according to any one of claims 1 to 10, comprising a plurality of terminals used by different users, each of which is equipped with the first output means and the second output means.

12. A slide specimen set is prepared from the same specimen, the slide specimen set further comprising a second stained slide specimen and one or more unstained slide specimens, the one or more unstained slide specimens being slide specimens of one or more sections located between the section of the first stained slide specimen and the section of the second stained slide specimen in the specimen, and the first generating means identifies each of the one or more unstained slide specimens based on the position of the target region of the second stained slide specimen and the position of the first or second target region of the first stained slide specimen, and further generates marking information for unstained slides for marking the target region on each unstained slide specimen, the slide specimen confirmation support system according to any one of claims 1 to 11.

13. A slide specimen confirmation support device comprising: an image acquisition means for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target region has been marked by a physician; a first output means for outputting an estimated result based on the image regarding the tumor cell content of the first target region; an identification means for identifying a second target region on the first stained slide specimen; a second output means for outputting an estimated result based on the image regarding the tumor cell content of the second target region; and a first generation means for generating target region change information indicating the use of the second target region in response to instructions from the user.

14. A slide specimen verification support method comprising: acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target region is marked by a physician; outputting an estimated result based on the image regarding the tumor cell content of the first target region; identifying a second target region on the first stained slide specimen; outputting an estimated result based on the image regarding the tumor cell content of the second target region; and generating target region change information indicating the use of the second target region in response to instructions from the user.

15. A slide specimen verification support program that causes at least one processor to execute: an image acquisition process for acquiring an image of a first stained slide specimen for gene panel testing, wherein a first target region is marked by a physician; a first output process for outputting an estimated result based on the image regarding the tumor cell content of the first target region; an identification process for identifying a second target region on the first stained slide specimen; a second output process for outputting an estimated result based on the image regarding the tumor cell content of the second target region; and a first generation process for generating target region change information indicating the use of the second target region in response to instructions from the user.

Images