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The PCR-based tests, which detect regions in the virus' nucleocapsid gene, may only be performed at their developers' CLIA-certified labs.
The template describes the data and information that should be submitted for EUA of collection kits or tests with a home self-collection component.
The DXRX marketplace, planned for launch in the fourth quarter of 2020, will provide a way for pharmaceutical companies, diagnostic firms, and laboratories to collaborate.
The infectious disease testing firm has developed a sequencing-based coronavirus assay, which it plans to commercialize through its sister firm BioID Genomics.
The test uses a proprietary at-home PCR nasal swab test with a turnaround time of 24 hours and is authorized for use by at-risk people.
The reference panel is an independent performance validation step for SARS-CoV-2 tests that are being used for clinical, not research, purposes.
The Food and Drug Administration's decision to halt a SARS-CoV-2 study has drawn criticism, according to Stat News.
The test kit is designed to detect regions of the virus' nucleocapsid and envelope genes in upper respiratory specimens and bronchoalveolar lavage.
The company's adaptive low-resource testing technology requires no instrumentation and limited equipment, making it adaptable to settings without clinical lab infrastructure.
The three RT-PCR-based tests are only authorized for use at their respective developers' CLIA-certified laboratories, according to the FDA.
The Washington Post reports on researchers' efforts to determine the effect of an increasingly common SARS-CoV-2 mutation.
Florida Politics reports Florida's law barring life, long-term care, and disability insurers from using genetic information in coverage decisions went into effect at the beginning of July.
A new analysis finds a link between popular media coverage of a scientific study and how often that paper is cited.
In Nature this week: CRISPR approaches to editing plant genomes, way to speed up DNA-PAINT, and more.