32 results about "Molecular Diagnostic Testing" patented technology

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.

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.

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.

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.

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.

Disclosed herein are the identification, cloning, and optimizing the lytic activity of one or more novel Bacillus lysin proteins, a method of selecting a lysin agent for use in molecular diagnostic testing that includes analyzing genome databases for Bacillus anthracis and near neighbors, selecting candidate genes encoding potential lytic enzymes based on conserved amino acid motifs as determined in peptidoglycan hydrolases, cloning the candidate genes in expression vector, isolating proteins thereof, and testing for lytic activity against Bacillus anthracis, and selecting an optimum gene of the candidate genes for optimizing lysis conditions.