The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said.
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.
Russia says its candidate SARS-CoV-2 vaccine has a very high efficacy rate in an initial analysis of clinical trial data, according to the Financial Times.
