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The approval was based on data showing superior efficacy for Alunbrig compared to Pfizer's Xalkori, especially in patients with brain metastasis.
The test is authorized for a variety of samples, including oral fluid collected with OraSure Technologies' Omnigene Oral OM-505 saliva collection device.
All three kits run on authorized PCR instruments and may be performed by any laboratory CLIA-certified to perform high-complexity tests.
The RT-PCR test targets the N gene and E gene regions of the SARS-CoV-2 genome in a multiplex format.
A professor of pathology and laboratory medicine, Gregory Tsongalis has published a paper detailing his lab's work on SARS-CoV-2 testing and the challenges faced.
The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
In a study published last month, Mammoth demonstrated the technology's sensitivity, specificity, and speed compared to PCR-based COVID-19 testing.
The two organizations announced a partnership earlier this year to manufacture and process Curative's oral fluid-based SARS-CoV-2 test.
The FDA granted Emergency Use Authorization for Everlywell's at-home nasal swab collection kit, which can be used with Fulgent and Assurance's tests.
The PCR-based test works with upper and lower respiratory specimens, including nasal swabs and sputum, and can be performed by high complexity labs.
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.