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More articles about Regulatory News & FDA Approvals

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.

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Nature News writes that additional details about the UK plan for an agency to support high-risk, high-reward science are needed.

The New York Times reports that the US Food and Drug Administration has authorized Johnson & Johnson's SARS-CoV-2 vaccine.

The Wall Street Journal writes new studies are giving glimpses into the origins of SARS-CoV-2.

In PLOS this week: analysis of Plasmodium population structure, qPCR assay to diagnose scabies, and more.