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 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.
The regulatory submission triggers a milestone payment, and Invitae will issue 5 million shares of its common stock to former ArcherDx securityholders.
The loop-mediated isothermal amplification test runs on a battery-powered device to provide self-testing individuals with results in approximately 30 minutes.
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 test will use a blood-based biopsy to detect patients with BRCA1, BRCA2, and/or ATM alterations in metastatic castration-resistant prostate cancer.
