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The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
Streck said its collection tube maintains native cell-free DNA populations and provides sample integrity by reducing the release of cellular genomic DNA.
The sequencing-based test for minimal residual disease can be use with blood and bone marrow samples in patients with chronic lymphocytic leukemia.
The expanded test can be used for genotype risk-based patient monitoring to prevent over-treatment, BD has said.
Quest expects to deploy the pooled sample technique at its laboratories in Chantilly, Virginia and Marlborough, Massachusetts by the end of next week with additional laboratories to follow.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The diagnostics firm is conducting a 1,000-person study to find T cell profiles associated with the immune response to COVID-19 and recovery from the disease.
Politico notes that the Biden Administration has not yet nominated a permanent Food and Drug Administration commissioner.
Anthony Fauci also informed the World Health Organization executive board that the US would be joining the COVAX initiative, according to CNBC.
A new preprint suggests some SARS-CoV-2 variants could affect the effectiveness of current vaccines, the Associated Press reports.
In Nature this week: Australian lungfish provides details on the movement of vertebrate life from water to land, and more.