Genotoxicity test automation system and method

Abstract

Disclosed are a genotoxicity test automation system and a method. The genotoxicity test automation system according to an embodiment of the present invention includes: a design unit that provides a plurality of preset test layouts for each test in response to receiving a test request for a specific test material from a user terminal and implements a complete test cycle design including test items and a test procedure according to one or more test layouts selected by a user through the user terminal; a test unit that receives and stores test data, obtained during a test carried out in accordance with the complete test cycle design, from the user terminal, provides report forms in the form of electronic documents pre-matched with each of the one or more test layouts, receives the test data transmitted in accordance with input items in the report forms, and generates a final report; and a verification unit that carries out a verification procedure for the test results according to preset test guidelines.

Description

Automated genotoxicity testing system and method

[0001] The disclosed embodiments relate to techniques for automating genotoxicity testing.

[0002] A variety of tests can be conducted to evaluate the properties or safety of test substances that affect human health.

[0003] Among the tests described above, genotoxicity testing can be applied in a variety of fields, including medicine, healthcare, cosmetics, and food. As the need for new vaccines against various diseases and infectious diseases grows, methods for conducting these tests more efficiently and systematically are being explored.

[0004] The disclosed embodiments are intended to provide a system and method for automating a genotoxicity test for computerizing process processing related to genotoxicity testing, and for automating management such as securing reliability of genotoxicity test data and processing related data according to a standardized format through the computerized system.

[0005] According to one embodiment, a system for automated genotoxicity testing includes: a design processing unit that provides an automated authoring tool for test design upon receiving a test request for a specific test substance from a user terminal, and processes a test full-cycle design including test items and test procedures according to at least one test layout set by a user through the user terminal; a test processing unit that receives and stores test data acquired during a test according to the test full-cycle design from the user terminal, and provides a report form in the form of an electronic document pre-matched with each of the at least one test layout, receives the test data transmitted according to input items in the report form, and generates a final report; and a verification unit that processes a verification procedure for test results according to a preset test guideline.

[0006] The above test processing unit can store log information in a preset format by matching each test data when storing the test data.

[0007] The above log information may include at least one of test identification information, test details, and update information, and the update information may include at least one of update date and time, update user, and update details.

[0008] The above test processing unit extracts and provides the pre-matched report form as a specific test layout is selected, receives and registers the test data entered according to the report form, and can create and match and store a history of test data for a related test using the log information.

[0009] The above test processing unit can process the following procedures, including the next user report, based on the design prior to the test, once data entry for required input items in the above report form is completed.

[0010] The above test guidelines may include at least one of the following: a first test guideline based on OECD guidelines and local guidelines, and a second test guideline based on laws related to electronic signatures and electronic records, including 21 CFR Part 11.

[0011] The above verification unit verifies the test results according to the test guidelines, generates a notification message for a test result in which an abnormality occurs in the verification result, and transmits the notification message to the user terminal, and the notification message may include a link for accessing the corresponding test data in which an abnormality occurred and related data.

[0012] According to another embodiment, a method for automating a genotoxicity test is provided, which is performed by an automated genotoxicity test system, comprising: providing an automated authoring tool for designing a test upon receiving a test request for a specific test substance from a user terminal; processing a test life cycle design including test items and test procedures according to at least one test layout set by a user through the user terminal; receiving and storing test data acquired during a test according to the test life cycle design from the user terminal, and providing a report form in the form of an electronic document pre-matched with each of the at least one test layout, receiving the test data transmitted according to input items in the report form, and generating a final report; and processing a verification procedure for a test result according to a preset test guideline.

[0013] The above-mentioned method for automating a genetic toxicity test can store the test data by matching each test data with log information in a preset format when storing the test data.

[0014] The above log information may include at least one of test identification information, test details, and update information, and the update information may include at least one of update date and time, update user, and update details.

[0015] In addition, a computer-readable recording medium recording a computer program for executing a method for implementing the disclosed embodiment may be further provided.

[0016] According to the disclosed embodiments, it is expected that by performing a full cycle design in relation to a genotoxicity test for a specific test substance and inputting test data acquired during the test according to the designed test full cycle design, it is possible to automatically computerize and construct various data including test data.

[0017] Additionally, according to the disclosed embodiments, the reliability of genotoxicity test data can be secured by applying a standardized workflow.

[0018] Additionally, according to the disclosed embodiments, standards and processes for linking with related tasks can be established.

[0019] Additionally, according to the disclosed embodiments, data related to genotoxicity testing can be processed in a standardized format.

[0020] Additionally, according to the disclosed embodiments, the reliability of test data can be secured through verification of the test data through various test guidelines.

[0021] FIG. 1 is a diagram illustrating a connection relationship between an automated genetic toxicity test system and a user terminal according to one embodiment.

[0022] Figure 2 is a drawing schematically illustrating an automated method for genetic toxicity testing according to one embodiment.

[0023] Figure 3 is a block diagram illustrating a detailed configuration of an automated genetic toxicity test system according to one embodiment.

[0024] Figures 4 to 10 are exemplary diagrams for explaining an automated method for genotoxicity testing according to one embodiment.

[0025] Figure 11 is a flow chart illustrating an automated method for genotoxicity testing according to one embodiment.

[0026] FIG. 12 is a block diagram illustrating a computing environment including a computing device according to one embodiment.

[0027] Hereinafter, specific embodiments of the present invention will be described with reference to the drawings. The following detailed description is provided to facilitate a comprehensive understanding of the methods, devices, and / or systems described herein. However, these are merely examples and the present invention is not limited thereto.

[0028] In describing embodiments of the present invention, if a detailed description of a known technology related to the present invention is judged to unnecessarily obscure the gist of the present invention, the detailed description will be omitted. In addition, the terms described below are terms defined in consideration of their functions in the present invention, and this may vary depending on the intention or custom of the user or operator. Therefore, the definitions should be made based on the contents throughout this specification. The terminology used in the detailed description is only for the purpose of describing embodiments of the present invention and should not be limited in any way. Unless clearly used otherwise, the singular form includes the plural form. In this description, expressions such as "comprises" or "having" are intended to indicate certain features, numbers, steps, operations, elements, parts or combinations thereof, and should not be construed to exclude the presence or possibility of one or more other features, numbers, steps, operations, elements, parts or combinations thereof other than those described.

[0029] The genotoxicity test disclosed in this example may be a field of testing that observes the phenomenon in which a test substance directly damages DNA or chromosomes, causing morphological changes or functional abnormalities. For example, genotoxicity testing may be used to identify the carcinogenic and mutagenic properties of pharmaceuticals, pesticides, and various chemical substances.

[0030] FIG. 1 is a diagram for explaining a connection relationship between a genetic toxicity test automation system and a user terminal according to one embodiment, FIG. 2 is a diagram for schematically explaining a genetic toxicity test automation method according to one embodiment, and FIG. 3 is a block diagram for explaining a detailed configuration of a genetic toxicity test automation system according to one embodiment.

[0031] Hereinafter, a description will be given with reference to FIGS. 4 to 10, which are exemplary diagrams for explaining an automated genetic toxicity test method according to one embodiment.

[0032] The automated genotoxicity test system (100) disclosed in this embodiment may mean a configuration for automating tasks such as project decision, reference information setting, test design, test result collection, and reporting related to genotoxicity testing.

[0033] Referring to Figure 1, the automated genotoxicity test system (100) may be configured to automatically establish and manage procedures and test data related to testing for a specific test substance. This automated genotoxicity test system (100) may be connected to a user terminal (200) to transmit and receive information.

[0034] The user terminal (200) may refer to a user terminal, including an operator who performs overall system management, including the design of the entire test cycle described below, through the genotoxicity test automation system (100), and a tester who inputs various test data generated during the test. In this case, the tester may include multiple people, including the tester performing the actual test and the test manager.

[0035] Referring to FIG. 2, the user terminal (200) may receive an automation authoring tool through a web interface implemented in the automated genotoxicity test system (100) via a network, set up test-related processes including test full cycle design, and perform various tasks related to the test including test data registration during test processing using the automated process generated through the automated authoring tool. In this case, the user terminal (200) may be any terminal having computing and communication functions, and may be connected to the web interface of the automated genotoxicity test system (100) through a web UI, email, messenger, or chat-bot. The user terminal (200) may be any wired or wireless terminal such as a mobile phone, desktop, or tablet PC.

[0036] When the automated genetic toxicity test system (100) processes tasks related to genetic toxicity testing, including designing the entire test cycle, through a web page or application on a user terminal (200), it may use a chatbot or messenger to provide messages such as test procedure guidance, input guidance for input items, and data input requests for required input items. At this time, messages sent and received through the chatbot or messenger may be subject to parsing and natural language processing, which extracts words from the message and breaks it down into sentences.

[0037] As shown in Fig. 2, the genetic toxicity test automation system (100) is also linked to each application for providing a number of services, including the PMS system, which is a project management system, and can transmit and receive necessary data to each other.

[0038] The genotoxicity test automation system (100) according to the present embodiment can implement hyper automation that automates and optimizes the work process by comprehensively utilizing automation, robotic process automation (RPA), artificial intelligence (AI), machine learning (ML), analysis, and automation tools and technologies. For example, the genotoxicity test automation system (100) can implement process automation by applying various automation technologies such as optical character recognition (OCR), machine learning, RPA, and chatbot. The process automation may mean that the work process related to the genotoxicity test, such as test design, test data input, reporting, and verification, is computerized and automatically processed according to preset standards. At this time, the present embodiment can minimize the manual work of the tester by applying a detection technology for the input document using deep learning.

[0039] Additionally, the automated genetic toxicity testing system (100) can utilize open APIs to connect with various third-party equipment and build an open ecosystem. For example, as an open system, the automated genetic toxicity testing system (100) can provide support for connecting with various testing equipment and provide an API for connecting with them.

[0040] In addition, the genotoxicity test automation system (100) can be expanded to a cloud service. Specifically, the genotoxicity test automation system (100) can be implemented in the form of a cloud server, allowing users (testers and operators) to access the system via a user terminal (200) from anywhere, regardless of location. In this environment, the genotoxicity test automation system (100) can provide an automated authoring tool for designing the entire test cycle using a web page or application to the user terminal (200). Thereafter, the user terminal (200) can access the genotoxicity test automation system (100) to process work processes such as registering test data or receiving verified test results. At this time, the genotoxicity test automation system (100) can provide a standardized multiple test layouts for designing the entire test cycle, provide data input items for standardized data acquisition, and generate a final report according to a standardized format. Through this, the present embodiment can implement data construction based on measurement standardization through large-scale data analysis.

[0041] A detailed description of the above-described automated genetic toxicity test system (100) will be provided later.

[0042] Referring to FIG. 3, the automated genotoxicity test system (100) includes a design processing unit (110), a test processing unit (130), and a verification unit (150). The components illustrated in FIG. 3 are not essential for implementing the automated genotoxicity test system (100) according to the present disclosure, and thus the automated genotoxicity test system (100) described herein may have more or fewer components than the components listed above. For example, the automated genotoxicity test system (100) may additionally include a communication unit, a memory, an input unit, an output unit, and the like.

[0043] The components illustrated in FIG. 3 may be communicatively connected to one another via a communications network (not shown). In some embodiments, the communications network may include the Internet, one or more local area networks, wire area networks, a cellular network, a mobile network, other types of networks, or a combination of these networks.

[0044] The design processing unit (110) provides an automated authoring tool for test design upon receiving a test request for a specific test substance from a user terminal (200), and can process a test full cycle design including test items and test procedures according to at least one test layout set by a user through the user terminal (200).

[0045] The above-mentioned pre-test cycle design may refer to the entire process related to non-clinical testing for a specific test substance. Referring to Fig. 6, the design processing unit (110) receives test substance-related files transmitted from an external system (e.g., a PMS system) (PMS input) and can identify the test substance based on these files.

[0046] Additionally, the design processing unit (110) can recognize and analyze the contents of test substance-related files transmitted from an external system, thereby automatically identifying requirements for designing the entire test cycle. At this time, the design processing unit (110) can utilize OCR technology to analyze the contents of the test substance-related files. For example, if the test substance-related files include test substance names and test types, the design processing unit (110) can automatically apply the identified information to the test cycle design through analysis of the test substance-related files without requiring separate data input from the tester.

[0047] The above-described tests may include at least one of a reverse mutation test, a chromosomal aberration test, an in vivo micronucleus test, an in vitro micronucleus test, an in vivo Comet assay, and an in vivo Pig-a gene mutation assay.

[0048] A reverse mutation test can refer to a test method that measures genotoxicity by using a microorganism in which the synthesis of a specific amino acid has been inhibited and confirming whether it is converted into an amino acid-synthesizing strain by a test substance. This is a test method that is quick and simple among genotoxicity tests and shows a very close correlation with the results of a carcinogenicity test, and can be widely used in the early screening stage of new drug development and in safety tests for pharmaceuticals, food additives, pesticides, and general chemicals. The chromosome aberration test can refer to a test method for measuring structural chromosome aberrations caused by a test substance. The in vivo micronucleus test can refer to a test method used to detect chromosome damage or mitotic apparatus damage induced in bone marrow or peripheral blood cells of rodents administered a test substance. The in vitro micronucleus test can refer to a test method for measuring substances that cause structural (clastogenic) and numerical (aneugenic) chromosome aberrations using mammalian cells. The above in vivo Comet assay is a test to evaluate DNA level damage in individual cells. It can mean a test to evaluate DNA damage by placing a single cell suspension in low melting agar gel, dissolving it, and performing electrophoresis under alkaline (pH>13) conditions. The above in vivo Pig-a gene mutation assay is an in vivo gene mutation assay and can mean a test method to detect mutation of the Pig-a gene on the X chromosome.

[0049] Referring to FIG. 4, the design processing unit (110) may include test items to be performed for each test. For example, a reversion mutation test may include test items including Bacteria Strain Selection, S9 Mix, Positive Control Selection, Control Condition, and Dose Condition. In this case, the test items may include items that the tester performs or must consider when performing the test.

[0050] Referring to FIG. 5, the design processing unit (110) may provide an automated authoring tool (e.g., the study layout designer of FIG. 5) for designing the entire test cycle. The automated authoring tool may have multiple test layouts for each test pre-generated and matched for designing the entire test cycle. This automated authoring tool may be executed via an application pre-installed on the user terminal (200) or displayed via a web page.

[0051] Referring to FIG. 6, the design processing unit (110) can set up a test cycle design based on multiple test layouts that must be performed in the test cycle from start to end for a specific test substance selected and transmitted as the user operates the automated authoring tool on the user terminal (200).

[0052] At this time, the design processing unit (110) can perform test design by providing multiple test layouts pre-matched to a specific test substance or a specific test through an automated authoring tool and allowing the user to select them.

[0053] The design processing unit (110) can perform a verification procedure for multiple test layouts selected by the user during the test cycle design, and generate and provide a notification message so that the user can recognize that the test layout does not match the test substance or the test.

[0054] The design processing unit (110) can perform a verification procedure on the test full cycle design selected and completed by the user, and generate and provide a notification message to notify the user when a test material or a test layout that must be included in the test is missing, or an unnecessary test layout is included.

[0055] Through verification of the test layout and test cycle design described above, this embodiment is expected to standardize the entire test process for genotoxicity testing. Furthermore, since the design processing unit (110) also performs verification procedures for the test layout set by the user, the reliability of standardization can be further enhanced.

[0056] The test processing unit (130) receives and stores test data acquired during test execution according to the test pre-cycle design from the user terminal (200), and provides a report form in the form of an electronic document pre-matched with at least one test layout, so that the test data transmitted according to the input items in the report form can be received to generate a final report.

[0057] For example, test data may include, but is not limited to, the number of color changes in a reagent obtained by a tester using test equipment, data calculated through machine counting, etc. Test data may vary by test substance or test.

[0058] Additionally, the test data may include both text data and image data (including still images and moving images).

[0059] The above-described input items may be items created so that data can be entered based on principles such as names, definitions, formats, and rules established in advance to standardize the data being entered.

[0060] The automated genotoxicity test system (100) can provide data entry guidance via a chatbot or messenger so that data can be entered into standardized input fields according to standardized rules. To this end, the automated genotoxicity test system (100) can preset data entry guidance for each input field via the test processing unit (130) and provide this guidance to the user terminal (200) via a chatbot or messenger.

[0061] The final report described above is a report based on a format for reporting the results of a genotoxicity test, and may be a report for enabling the test results to be printed according to a standardized manual (e.g., genotoxicity test result report format) shared in advance among multiple organizations, including public organizations.

[0062] When storing test data, the test processing unit (130) can match each test data with log information in a preset format and store it. This log information can be used to identify the entity, time, location, etc. that performed changes or updates to the test data. For example, log information can be utilized to verify the possibility of data manipulation in test data.

[0063] The above log information may include at least one of test identification information, test details, and update information.

[0064] The above test identification information may include, but is not limited to, the test name, test request date, and version, and information for identifying the test being performed may be added and changed.

[0065] The above test details may include test processing details, test progress status, and various other matters occurring during the test. The operator may add or change the included information. The above test processing details refer to the actual actions taken by the user (e.g., the tester) during the test. For example, this could be dissolving 500 mg of test substance into 1 ml of DMSO.

[0066] The above update information may include at least one of the following: update date, update user, and update details. However, the update information is not limited thereto, and various information related to updating test data may be added or modified. In this embodiment, test permissions may be preset for each user (e.g., a tester), and the level of test data accessible based on the test permissions may also be preset. To this end, each test data item and the input items for entering the test data may have their levels preset, and access permissions may be set accordingly based on these levels.

[0067] Referring to FIGS. 7 to 10, the test processing unit (130) may extract and provide a pre-matched report form as a specific test layout is selected. For example, in the case of a reversion mutation test, the report form may include an electronic document report form that includes input items that must be entered corresponding to each of the reversion mutation test record sheets, media preparation and inoculation use records, OD value measurement records, test substance and S9 preparation records, test substance treatment records, and reversion mutation colony count sheets.

[0068] The test processing unit (130) receives and registers test data entered according to the report form, and can create, match, and store a history of test data for a related test using log information. The history of the test data may mean that it is created to check matters occurring during the processing of a genotoxicity test in the form of a history for each test. For example, the history of the test data may be created to include at least one or more of the test substance name, test name, data reception date, prescription date, version, test details, update user, and update date and time (including date and time). At this time, the history of the test data may be created to be listed in chronological order according to the data occurrence date or in an order preset by the operator, thereby making it easy to check.

[0069] When data entry for required input items in the report form is completed, the test processing unit (130) can process the following procedures, including the next user report, based on the test pre-cycle design.

[0070] For example, when data entry for required input items in the report form is completed, the test processing unit (130) can process the next procedure, such as starting the next test procedure, generating a final report, or sending an email for reporting to a superior, according to the test cycle design as shown in FIG. 6.

[0071] As shown in FIGS. 7 to 10, the report form may include multiple input items to be recorded during a test. For example, the input items may include all information related to the ongoing test, including Experiment ID, Experiment Title, Experiment Category, Version, Activation, Update User, Update Date Time, Activate, Received Date, Storage Date, and Confirmation Date.

[0072] The test processing unit (130) can receive, store, and manage the test results verified by the verification unit (130). Although not shown, the genotoxicity test automation system (100) may have an internal or external database that stores various data related to the system, including test data and test results.

[0073] The test processing unit (130) can provide various data according to the user's request. At this time, the test processing unit (130) can authenticate the user and provide the data according to the access rights preset for each data.

[0074] The verification unit (150) can process the verification procedure for test results according to preset guidelines. The test results may include multiple test data collected during test processing.

[0075] The above test guidelines may include at least one of the following: a first test guideline based on OECD guidelines and local guidelines, and a second test guideline based on laws related to electronic signatures and electronic records, including 21 CFR Part 11.

[0076] The first test guideline may be a test guideline intended to demonstrate that test data have been acquired through an appropriate method. Specifically, the first test guideline may include guidelines from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the Organization for Economic Cooperation and Development (OECD) for genotoxicity testing of pharmaceuticals, etc.

[0077] The above local guidelines are based on the Act on Registration and Evaluation of Chemical Substances, etc., and may include test guidelines for data reliability, evaluation of test methods, evaluation of report result description, statistical analysis of results, and uncertainty assessment of non-test data.

[0078] The above second test guideline may be a test guideline for detecting the possibility of manipulation of experimental data. Specifically, 21 CFR Part 11 covers Electronic Records, Electronic Signatures, Validation, Glossary of Terms, Time Stamps, Maintenance of Electronic Records, Electronic Copies of Electronic Records, Limiting system access to authorized individuals, Use of operational system checks, Use of authority checks, Use of device checks, Determination that persons who develop, maintain, or use electronic systems have the education, training, and experience to perform their assigned tasks, Establishment of and adherence to written policies that hold individuals accountable for actions initiated under their electronic signatures, Appropriate controls over systems documentation,It may include guidelines related to at least one of controls for open systems corresponding to controls for closed systems and requirements related to electronic signatures.

[0079] The verification unit (150) can verify test results according to test guidelines, and generate a notification message for test results that have an abnormality in the verification results, and transmit the notification message to the user terminal (200). The notification message can include a link for accessing the test data in which the abnormality occurred and related data.

[0080] When performing verification on test results, the verification unit (150) can output verification results according to test guidelines by inputting data within the test results using a pre-learned artificial intelligence model.

[0081] The above artificial intelligence model may be a pre-trained model to output test verification results according to genotoxicity test results based on past genotoxicity test results, test guidelines, test results that satisfy the test guidelines, and test results that do not satisfy the test guidelines.

[0082] According to the present disclosure, the automated genotoxicity test system (100) can perform computations for learning the artificial intelligence model described above. A processor (not shown) provided within the automated genotoxicity test system (100) can perform computations for learning a neural network, such as processing input data for learning in deep learning, extracting features from the input data, calculating errors, and updating the weights of the neural network using backpropagation.

[0083] The above neural network model may be a deep neural network. In the present disclosure, neural network, network function, and neural network may be used interchangeably. A deep neural network (DNN) may refer to a neural network that includes multiple hidden layers in addition to an input layer and an output layer. Using a deep neural network, it is possible to identify latent structures of data. That is, it is possible to identify latent structures of photos, text, videos, voices, and music (e.g., what objects are in the photo, what the content and emotion of the text are, what the content and emotion of the voice are, etc.). A deep neural network may include a convolutional neural network (CNN), a recurrent neural network (RNN), a restricted Boltzmann machine (RBM), a deep belief network (DBN), a Q network, a U network, a Siamese network, etc.

[0084] Convolutional neural networks (CNNs) are a type of deep neural network that include neural networks containing convolutional layers. CNNs are a type of multilayer perceptron designed to use minimal preprocessing. CNNs can be composed of one or more convolutional layers and artificial neural network layers combined with them. CNNs can additionally utilize weight and pooling layers. This structure allows CNNs to fully utilize two-dimensional input data. CNNs can be used to recognize objects in images. CNNs can process image data by representing it as a matrix with dimensions. For example, in the case of image data encoded in RGB (red-green-blue), each of the R, G, and B colors can be represented as a two-dimensional (for example, in a two-dimensional image) matrix. That is, the color value of each pixel of the image data can be an element of a matrix, and the size of the matrix can be the same as the size of the image. Therefore, the image data can be represented as three two-dimensional matrices (a three-dimensional data array).

[0085] In a convolutional neural network, a convolutional process (input and output of a convolutional layer) can be performed by moving the convolutional filter and multiplying the matrix elements at each location of the image with the convolutional filter. The convolutional filter can be composed of an n*n matrix. The convolutional filter can generally be composed of a fixed-shape filter that is smaller than the total number of pixels in the image. That is, when an m*m image is input to a convolutional layer (for example, a convolutional layer whose convolutional filter has a size of n*n), a matrix representing n*n pixels containing each pixel of the image can be component-wise multiplied (i.e., each element of the matrix is ​​multiplied) with the convolutional filter. By multiplying with the convolutional filter, a component matching the convolutional filter can be extracted from the image. For example, a 3*3 convolutional filter for extracting up and down straight line components from an image can be configured as [[0,1,0], [0,1,0], [0,1,0]]. When a 3*3 convolutional filter for extracting up and down straight line components from an image is applied to an input image, up and down straight line components matching the convolutional filter from the image can be extracted and output. A convolutional layer can apply a convolutional filter to each matrix for each channel representing an image (i.e., R, G, B colors in the case of an R, G, B coded image). A convolutional layer can extract features matching the convolutional filter from the input image by applying a convolutional filter to the input image. The filter value of the convolutional filter (i.e., the value of each element of the matrix) can be updated by backpropagation during the learning process of a convolutional neural network.

[0086] A subsampling layer can be connected to the output of a convolutional layer to simplify the output of the convolutional layer and reduce memory usage and computational amount. For example, when the output of the convolutional layer is input to a pooling layer having a 2*2 max pooling filter, the image can be compressed by outputting the maximum value included in each patch for each 2*2 patch from each pixel of the image. The above-described pooling may be a method of outputting the minimum value in a patch or the average value of a patch, and any pooling method may be included in the present disclosure.

[0087] A convolutional neural network may include one or more convolutional layers and subsampling layers. A convolutional neural network can extract features from an image by repeatedly performing convolutional and subsampling processes (e.g., the aforementioned max pooling). Through repeated convolutional and subsampling processes, the neural network can extract global features of the image.

[0088] The output of a convolutional layer or a subsampling layer can be input to a fully connected layer. A fully connected layer is a layer in which all neurons in one layer are connected to all neurons in the neighboring layer. A fully connected layer can refer to a structure in a neural network in which all nodes in each layer are connected to all nodes in other layers.

[0089] At least one of the CPU, GPGPU, and TPU of the processor can process network function learning. For example, the CPU and GPGPU can jointly process network function learning and data classification using the network function. Furthermore, in one embodiment of the present disclosure, processors of multiple computing devices can be used together to process network function learning and data classification using the network function. Furthermore, a computer program executed on a computing device according to one embodiment of the present disclosure may be a CPU, GPGPU, or TPU executable program.

[0090] FIG. 11 is a flowchart illustrating an automated genotoxicity test method according to one embodiment. The method illustrated in FIG. 11 may be performed, for example, by the aforementioned automated genotoxicity test system (100). While the illustrated flowchart describes the method as divided into multiple steps, at least some of the steps may be performed in reverse order, combined with other steps and performed together, omitted, divided into substeps and performed, or one or more steps not illustrated may be added and performed.

[0091] In steps 1100 and 1200, the genotoxicity test automation system (100) may provide an automated authoring tool for test design upon receiving a test request for a specific test substance from a user terminal (200).

[0092] At step 1300, the genetic toxicity test automation system (100) can process a test cycle design including test items and test procedures according to at least one test layout set by a user through a user terminal (200).

[0093] At step 1400, the genotoxicity test automation system (100) receives and stores test data acquired during test execution according to the test full cycle design from the user terminal (200), and provides a report form in the form of an electronic document pre-matched with at least one test layout, so that the test data transmitted according to the input items in the report form can be received to generate a final report.

[0094] At this time, the final report is a report based on a format for reporting the results of a genotoxicity test, and may be a report for enabling the test results to be printed according to a standardized manual (e.g., genotoxicity test result report format) shared in advance among multiple organizations, including public organizations.

[0095] When storing test data, the genetic toxicity test automation system (100) can store each test data by matching it with log information in a preset format.

[0096] The above log information may include at least one of test identification information, test details, and update information. The update information may include at least one of the following: update date and time, update user, and update details.

[0097] At step 1500, the genotoxicity test automation system (100) can process the verification procedure for the test results according to preset test guidelines.

[0098] FIG. 12 is a block diagram illustrating a computing environment including a computing device according to one embodiment. In the illustrated embodiment, each component may have different functions and capabilities other than those described below, and may include additional components other than those described below.

[0099] The illustrated computing environment (10) includes a computing device (12). The computing device (12) may be one or more components included in an automated genetic toxicity test system (100) according to one embodiment.

[0100] A computing device (12) includes at least one processor (14), a computer-readable storage medium (16), and a communication bus (18). The processor (14) may cause the computing device (12) to operate according to the exemplary embodiments mentioned above. For example, the processor (14) may execute one or more programs stored in the computer-readable storage medium (16). The one or more programs may include one or more computer-executable instructions, which, when executed by the processor (14), may be configured to cause the computing device (12) to perform operations according to the exemplary embodiments.

[0101] A computer-readable storage medium (16) is configured to store computer-executable instructions or program code, program data, and / or other suitable forms of information. A program (20) stored in the computer-readable storage medium (16) includes a set of instructions executable by the processor (14). In one embodiment, the computer-readable storage medium (16) may be a memory (volatile memory such as random access memory, non-volatile memory, or a suitable combination thereof), one or more magnetic disk storage devices, optical disk storage devices, flash memory devices, any other form of storage medium that can be accessed by the computing device (12) and store desired information, or a suitable combination thereof.

[0102] A communication bus (18) interconnects various other components of the computing device (12), including the processor (14) and computer-readable storage media (16).

[0103] The computing device (12) may also include one or more input / output interfaces (22) that provide interfaces for one or more input / output devices (24) and one or more network communication interfaces (26). The input / output interfaces (22) and the network communication interfaces (26) are connected to the communication bus (18). The input / output devices (24) may be connected to other components of the computing device (12) via the input / output interfaces (22). Exemplary input / output devices (24) may include input devices such as pointing devices (such as a mouse or a trackpad), a keyboard, a touch input device (such as a touchpad or a touchscreen), a voice or sound input device, various types of sensor devices and / or photographing devices, and / or output devices such as display devices, printers, speakers and / or network cards. The exemplary input / output devices (24) may be included within the computing device (12) as a component constituting the computing device (12), or may be connected to the computing device (12) as a separate device distinct from the computing device (12).

[0104] The disclosed embodiments may be implemented in the form of a recording medium storing computer-executable instructions. The instructions may be stored in the form of program code, and when executed by a processor, may generate program modules to perform the operations of the disclosed embodiments. The recording medium may be implemented as a computer-readable recording medium.

[0105] While representative embodiments of the present invention have been described in detail above, those skilled in the art will appreciate that various modifications to the above-described embodiments are possible without departing from the scope of the present invention. Therefore, the scope of the present invention should not be limited to the described embodiments, but should be determined not only by the claims set forth below but also by equivalents thereof.

Claims

1. A design processing unit that provides an automated authoring tool for test design upon receiving a test request for a specific test substance from a user terminal, and processes a test full cycle design including test items and test procedures according to at least one test layout set by a user through the user terminal; A test processing unit that receives and stores test data acquired during a test according to the above test pre-cycle design from the user terminal, provides a report form in the form of an electronic document pre-matched with each of the at least one test layout, receives the test data transmitted according to input items in the report form, and generates a final report; and An automated genotoxicity test system, comprising a validation unit that processes validation procedures for test results according to preset test guidelines.

2. In claim 1, The above test processing unit, An automated genetic toxicity test system that stores the above test data by matching each test data with log information in a preset format.

3. In claim 2, The above log information includes at least one of test identification information, test details, and update information. The above update information includes at least one of update date, update user, and update details.

4. In claim 3, The above test processing unit, An automated genetic toxicity test system that extracts and provides a pre-matched report form as a specific test layout is selected, receives and registers the test data entered according to the report form, and creates and matches and stores a history of test data for a related test using the log information.

5. In claim 4, The above test processing unit, An automated genetic toxicity test system that processes the following procedures, including the next user report, based on the design of the pre-test period, upon completion of data entry for the required fields in the above report form.

6. In claim 1, The above test guidelines are: An automated genotoxicity testing system comprising at least one of the following: a first test guideline based on OECD guidelines and local guidelines, and a second test guideline based on laws related to electronic signatures and electronic records, including 21 CFR Part 11.

7. In claim 6, The above verification department, The above test results are verified according to the above test guidelines, and a notification message is generated for the test results in which an abnormality is found in the verification results and transmitted to the user terminal. The above notification message includes a link for accessing the test data and related data in which an abnormality occurred, and an automated genotoxicity test system.

8. A method performed by an automated genetic toxicity test system, A step of providing an automated authoring tool for test design upon receiving a test request for a specific test substance from a user terminal; A step of processing a test cycle design including test items and test procedures according to at least one test layout set by a user through the user terminal; A step of receiving and storing test data acquired during a test according to the above test cycle design from the user terminal, providing a report form in the form of an electronic document pre-matched with each of the at least one test layout, and receiving the test data transmitted according to input items in the report form to generate a final report; and A method for automating a genotoxicity test, comprising a step of processing a verification procedure for test results according to preset test guidelines.

9. In claim 8, A method for automating a genotoxicity test, wherein when saving the above test data, each test data is matched with log information in a preset format and saved.

10. In claim 9, The above log information includes at least one of test identification information, test details, and update information. A method for automating a genetic toxicity test, wherein the above update information includes at least one of update date and time, update user, and update details.

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