influenza
The firm will submit its SARS-CoV-2 test and Talis One instrument to the US Food and Drug Administration for Emergency Use Authorization in the second quarter.
Hologic to Acquire Finnish MDx Firm Mobidiag for Approximately $795M
Hologic intends to invest in assay development for Mobidiag's Novodiag PCR platform, which provides high-level multiplexing to detect infectious disease organisms.
Amazon, NeuMoDx, Becton Dickinson Get FDA Emergency Use Authorizations for Coronavirus Tests
Amazon said that it will use its test for employees and other individuals who enter its facilities as part of its COVID-19 preparedness and response program.
FDA Warns of Potential False Positive Results With Roche Cobas Liat Rapid SARS-CoV-2, Flu Test
The issues may relate to sporadically leaking assay tubes causing an obstructed optical path in the Cobas Liat analyzer or abnormal PCR cycling in the reaction tubes.
Abbott Gets FDA EUA for Test That Detects Coronavirus, Three Other Respiratory Infections
The company also said that a previously granted EUA for its Alinity m SARS-CoV-2 assay has been expanded to include asymptomatic individuals and pooled testing.