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Applied BioCode's test may be performed by any CLIA-certified lab, while Kaiser Permanente's and Emory's must be run at their developers' labs.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
The PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in various respiratory specimens including nasopharyngeal swabs.
Cue Health's test is authorized for use at the point of care, while Tide and TBG's PCR-based tests are performed by CLIA-certified laboratories.
The test detects SARS-CoV-2 from nasopharyngeal swab specimens and runs on standard qPCR instruments, including Thermo Fisher's Applied Biosystems 7500 Fast machine.
The Illumina COVIDSeq Test is a high-throughput, in vitro diagnostic that provides results in 24 hours. The test is for use with the NovaSeq 6000 Sequencing system.
The test is the second from Euroimmun to receive EUA from the agency. Its antibody test received the designation last Month.
The company said clinical services revenues and diagnostic testing volumes fell during the quarter due to the negative impact of the COVID-19 pandemic.
Phosphorus' test is authorized for use with saliva samples collected by healthcare providers or patients at home using DNA Genotek's collection kit.
The test is designed to detect a nucleic acid sequence from the SARS-CoV-2 E gene in various respiratory specimens including nasal swabs.
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.