41 results about "Molecular Diagnostic Testing" patented technology

The present invention provides systems, methods, and compositions for performing molecular tests. In particular, the present invention provides methods, compositions and systems for generating target sequence-linked solid supports (e.g., beads) using a solid support linked to a plurality of capture sequences and capture primers composed of a 3′ target-specific portion and a 5′ capture sequence portion. In certain embodiments, the target sequence linked solid support is used in sequencing methods (e.g., pyrosequencing, zero-mode waveguide type sequencing, nanopore sequencing, etc.) to determine the sequence of the target sequence (e.g., in order to detect the identity of a target nucleic acid in sample).

A container for storing a biological sample for molecular diagnostic testing and / or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A breakable membrane, such as a piercable foil, extends within the container and separates the two chambers. When the breakable membrane is broken, fluid can pass between the first and second chambers. The membrane may be broken through an activator on the closure, such as a depressible member or a rotatable carrier, causing the sample holder to break through the membrane.

Methods and compositions are provided for the identification of a molecular diagnostic test for cancer. The test identifies cancer subtypes that are responsive to anti-angiogenesis therapeutics and enables classification of a patient within this subtype. The present invention can be used to determine whether patients with cancer are clinically responsive or non-responsive to a therapeutic regimen prior to administration of any anti-angiogenic agent. This test may be used in different cancer types and with different drugs that directly or indirectly affect angiogenesis or angiogenesis signalling. In addition, the present invention may be used as a prognostic indicator for certain cancer types. In particular, the present invention is directed to the use of certain combinations of predictive markers, wherein the expression of the predictive markers correlates with responsiveness or non-responsiveness to a therapeutic regimen.

Apparatus and methods for practicing telemedicine in the form of software systems acting over a network and kits containing laboratory supplies and equipment to organize the laboratory operations and interpret the results of molecular diagnostic testing are disclosed. At least two computers in communication over the Internet or other network are used, a remote computer located at a remote site and a central server located at a central site. The remote site may be geographically distant from the central site. A specimen is procured from a patient proximate to the remote site. Laboratory operations are conducted on the specimen at the remote site. The laboratory data resulting from the laboratory operations is interpreted by an expert reviewer who may be located at the central site, and a report is then transmitted back to the remote site.

Apparatus and methods for practicing telemedicine in the form of software systems acting over a network and kits containing laboratory supplies and equipment to organize the laboratory operations and interpret the results of molecular diagnostic testing are disclosed. At least two computers in communication over the Internet or other network are used, a remote computer located at a remote site and a central server located at a central site. The remote site may be geographically distant from the central site. A specimen is procured from a patient proximate to the remote site. Laboratory operations are conducted on the specimen at the remote site. The laboratory data resulting from the laboratory operations is interpreted by an expert reviewer who may be located at the central site, and a report is then transmitted back to the remote site.

Methods and compositions are provided for the identification of a molecular diagnostic test for cancer. The test identifies cancer subtypes that have an up-regulation or a down-regulation in biomarker expression related to angiogenesis and vascular development. The present invention can be used to determine whether patients with cancer are clinically responsive or non-responsive to a therapeutic regimen prior to administration of any anti-angiogenic agent. This test may be used in different cancer types and with different drugs that directly or indirectly affect angiogenesis or angiogenesis signalling. In addition, the present invention may be used as a prognostic indicator for certain cancer types. In particular, the present invention is directed to the use of certain combinations of predictive markers, wherein the expression of the predictive markers correlates with responsiveness or non-responsiveness to a therapeutic regimen.

Methods and compositions are provided for the identification of a molecular diagnostic test for cancer. The test identifies cancer subtypes that have an up-regulation or a down- regulation in biomarker expression related to angiogenesis and vascular development. The present invention can be used to determine whether patients with cancer are clinically responsive or non-responsive to a therapeutic regimen prior to administration of any anti- angiogenic agent. This test may be used in different cancer types and with different drugs that directly or indirectly affect angiogenesis or angiogenesis signalling. In addition, the present invention may be used as a prognostic indicator for certain cancer types. In particular, the present invention is directed to the use of certain combinations of predictive markers, wherein the expression of the predictive markers correlates with responsiveness or non-responsiveness to a therapeutic regimen.

Methods and compositions are provided for the identification of a molecular diagnostic test for cancer. The test defines a novel DNA damage repair deficient molecular subtype and enables classification of a patient within this subtype. The present invention can be used to determine whether patients with cancer are clinically responsive or non-responsive to a therapeutic regimen prior to administration of any chemotherapy. This test may be used in different cancer types and with different drugs that directly or indirectly affect DNA damage or repair, such as many of the standard cytotoxic chemotherapeutic drugs currently in use. In particular, the present invention is directed to the use of certain combinations of predictive markers, wherein the expression of the predictive markers correlates with responsiveness or non-responsiveness to a therapeutic regimen.

A low-cost, non-instrumented, easy-to-use disposable platform for extraction, stabilization, and preservation of viral RNA in specimens at the point of collection is described. The system may use chemical heating. The platform performs the following steps: specimen lysis, RNA extraction, and RNA stabilization in a modular approach. This modular approach confers versatility to the product for application to multiple targets such as avian flu, and HIV, specimens such as blood, nasal swabs, and downstream applications such as PCR or transcription-mediated amplification. The technology described is a point-of-care specimen-processing platform generically applicable to both emerging point-of-care and central-facility molecular diagnostic tests, as well as to surveillance applications.

A medical apparatus (FDA Classifications: “Sputum Specimen [In-Home] Self-Collection Device” and “In Vitro Medical Diagnostic Device”) and method for self-collection, transport, decontamination and storage preservation of expectorated sputum specimens, to optimize specimen quality and reliability of clinical laboratory stain interpretation, culture and molecular diagnostic tests, thereby improving laboratory support for pathogen-specific treatment (antibiotic stewardship).

A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

Methods and systems are provided for point-of-care nucleic acid amplification and detection. One embodiment of the point-of-care molecular diagnostic system includes a cartridge and an instrument. The cartridge can accept a biological sample, such as a urine or blood sample. The cartridge, which can comprise one or more of a loading module, lysis module, purification module and amplification module, is inserted into the instrument which acts upon the cartridge to facilitate various sample processing steps that occur in order to perform a molecular diagnostic test.

The present disclosure relates to the identification of genes and gene combinations that are correlated with patients having or being predisposed to developing pancreatic ductal adenocarcinoma (PDAC). In some instances, methods herein utilize panels of 5 or 10 genes to accurately diagnose PDAC, determine the likelihood of developing PDAC, or determine the severity / stages of PDAC. These panels may be used in a molecular diagnostic test.

A device for use in molecular diagnostics testing includes at least one sealed reagent storage container, and at least one opener for unsealing the reagent storage container. The device further includes an actuator coupled to the reagent storage container and opener such that moving the actuator brings the reagent storage container and the opener together so that the opener unseals the reagent storage container.

Methods and compositions are provided for the identification of a molecular diagnostic test for lung cancer. The test defines a novel DNA damage repair deficient molecular subtype and enables classification of a patient within this subtype. The present invention can be used to determine whether patients with NSCLC are clinically responsive or non-responsive to a therapeutic regimen prior to administration of any chemotherapy. This test may be used with different drugs that directly or indirectly affect DNA damage or repair, such as many of the standard cytotoxic chemotherapeutic drugs currently in use. In particular, the present invention is directed to the use of certain combinations of predictive markers, wherein the expression of the predictive markers correlates with responsiveness or non-responsiveness to a therapeutic regimen.

A container for storing a biological sample for molecular diagnostic testing and / or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A transitional barrier, such as a valve, is in fluid communication between the two chambers. The transitional barrier is transitional between a first position in which the first chamber is in fluid isolation from the second chamber, and a second position in which fluid can pass from at least one of the first and second chambers to the other of the first and second chambers.

Described herein are materials, methods, and kits enabling accurate and reproducible two-color reverse-transcription real-time quantitative PCR (RT-qPCR) for quality-controlled molecular diagnostic testing of samples that may contain degraded RNA. In certain aspects described herein are materials, methods, and kits for use in the molecular diagnostic testing of lung cancer in FFPE samples and / or fresh-frozen samples. Also described herein are materials and methods to control for inter-experimental variation occurring during two-color RT-qPCR amplification arising from variation in fluorescence specific activity, use of different thermocyclers, and inter-laboratory differences.

The invention discloses a PCR instrument with multiple temperature control modules asynchronously selectable channels and a detection method thereof; it belongs to the field of medical inspection and testing instruments and molecular diagnosis and detection instruments; its technical gist is that it includes: m temperature control modules, m A reaction pool component module and a fluorescence detection component; the fluorescence detection module is an excitation light-receiving light integrated module structure; the optical fiber fixing plate is arranged with through holes, the number of the through holes, optical fibers, and reaction pools is the same, and the optical fiber and fluorescence detection module They are respectively located on both sides of the optical fiber fixing plate; one end of the optical fiber is fixedly communicated with the through holes one by one, and the other end is inserted into the reaction pool. The present invention aims to provide a PCR instrument with multiple temperature control modules asynchronously optional channels and a detection method thereof. A set of fluorescence detection system can collect the fluorescence signals of m PCR reaction pools without interfering with each other; the channels are optional and can be To better meet the needs of users and reduce costs, the universal enhancement of equipment.

A method includes coupling a molecular diagnostic test device to a power source. A biological sample is conveyed into a sample preparation module. The device is then actuated by only a single action to cause the device to perform the following functions without further user action. First, the device heats the sample via a heater of the sample preparation module to lyse a portion of the sample. Second, the device conveys the lysed sample to an amplification module and heats the sample within a reaction volume of the amplification module to amplify a nucleic acid thereby producing an output solution containing a target amplicon. The device then reacts, within a detection module, each of (i) the output solution and (ii) a reagent formulated to produce a signal that indicates a presence of thetarget amplicon within the output solution. A result associated with the signal is then read.

A container for storing a biological sample for molecular diagnostic testing and / or histological testing is provided. The container includes a first chamber for receiving a sample holder therein, a second chamber, and a closure for enclosing the container. A breakable membrane, such as a piercable foil, extends within the container and separates the two chambers. When the breakable membrane is broken, fluid can pass between the first and second chambers. The membrane may be broken through an activator on the closure, such as a depressible member or a rotatable carrier, causing the sample holder to break through the membrane.

The invention is directed to three-dimensional, engineered, bioprinted biological tissue constructs exhibiting a liver disorder, methods of making the constructs, and use of the constructs in assays, such as drug testing and molecular diagnostic testing, including methods of assessing the ability of a candidate therapeutic agent to reverse, reduce, or prevent a liver disorder, and methods for biomarker discovery.

A hand-held molecular diagnostic test device includes a housing, an amplification (or PCR) module, and a detection module. The amplification module is configured to receive an input sample, and defines a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and a reagent formulated to produce a signal that indicates a presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

The invention relates to a device for use in molecular diagnostics testing comprising:at least one reagent storage container, the reagent storage container being sealed;at least one opener for unsealing the reagent storage container;an actuator coupled to at least one of the reagent storage container and the opener such that moving the actuator brings the reagent storage container and the opener together so that the opener unseals the reagent storage container.

Shapley values (SVs) have become an important tool to further the goal of explainability of machine learning (ML) models. However, the computational load of exact SV calculations increases exponentially with the number of attributes. Hence, the calculation of SVs for models incorporating large numbers of interpretable attributes is problematic. Molecular diagnostic tests typically seek to leverage information from hundreds or thousands of attributes, often using training sets with fewer instances. Methods are described for evaluate SVs using Monte Carlo sampling or exact calculation in polynomial time (i.e., reasonably quickly and efficiently) using the architecture of a ML model designed for robust molecular test generation, and without requiring classifier retraining.

A handheld molecular diagnostic test device includes a housing, an amplification (or PCR) module and a detection module. The amplification module is configured to receive an input sample and define a reaction volume. The amplification module includes a heater such that the amplification module can perform a polymerase chain reaction (PCR) on the input sample. The detection module is configured to receive an output from the amplification module and reagents formulated to generate a signal indicative of the presence of a target amplicon within the input sample. The amplification module and the detection module are integrated within the housing.

Described herein are materials, methods, and kits enabling accurate and reproducible two-color reverse-transcription real-time quantitative PCR (RT-qPCR) for quality-controlled molecular diagnostic testing of samples that may contain degraded RNA. In certain aspects described herein are materials, methods, and kits for use in the molecular diagnostic testing of lung cancer in FFPE samples and / or fresh-frozen samples. Also described herein are materials and methods to control for inter-experimental variation occurring during two-color RT-qPCR amplification arising from variation in fluorescence specific activity, use of different thermocyclers, and inter-laboratory differences.

Methods and systems are provided for point-of-care nucleic acid amplification and detection. One embodiment of the point-of-care molecular diagnostic system includes a cartridge and an instrument. The cartridge can accept a biological sample, such as a urine or blood sample. The cartridge, which can comprise one or more of a loading module, lysis module, purification module and amplification module, is inserted into the instrument which acts upon the cartridge to facilitate various sample processing steps that occur in order to perform a molecular diagnostic test.