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The EUA from FDA is the first for a diagnostic test for at-home, self-collection of patient samples for detecting the coronavirus and the flu.
The test originally received Emergency Use Authorization in February for the detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens.
The clinical next-generation sequencing instrument is Illumina's second to receive approval from China's National Medical Products Administration.
The FDA last week also reissued an EUA for a PCR-based SARS-CoV-2 test from Quest Diagnostics to permit its use with pooled samples.
The RT-PCR-based test was first authorized earlier this year for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.
The FDA also reissued Emergency Use Authorizations for SARS-CoV-2 tests from Roche and Express Gene to reflect their permitted use with additional sample types.
Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.
The kit is designed for use with samples stored in the company's CE-marked DNA/RNA Shield sample collection and preservation devices.
The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.
The company said that its Aptima HIV-1 molecular test utilizes a dual-target approach against highly conserved regions in the HIV genome.
The firm CE marked its RespiFinder 2Smart kit for SARS-CoV-2 and MERS-CoV testing, as well as the RealAccurate Quadriplex Flu/COVID-19 PCR kit.
One of the tests is customized for use on Bioneer's automated ExiStation instrument, while the other is compatible with various standard PCR systems.
The loop-mediated isothermal amplification test runs on a battery-powered device to provide self-testing individuals with results in approximately 30 minutes.
The company said that it has received CE marks for two additional SARS-CoV-2 tests, including one that detects the virus and influenza A/B.
Qiagen received CE IVD marking for its NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test and for a saliva collection kit for its single-plex NeuMoDx SARS-CoV-2 assay.
The agency approved Agilent/Dako's PD-L1 IHC test for identifying TNBC patients who are most likely to respond to Keytruda and chemo.
The RT-PCR-based test is designed for the qualitative detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens.
The test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.
The RT-PCR-based test was first authorized in March for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.
The test was first authorized in May for the detection of the SARS-CoV-2 N, E, and ORF1a genes in nasopharyngeal swabs and other specimens.
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.