Mesa Biotech
FDA Classifies Mesa Biotech Recall of Accula SARS-CoV-2 Tests as Class I
On April 6, Mesa recalled certain test kit lots because they had an increased risk of yielding false positive results due to contamination at the manufacturing facility.
Miniaturized sample-to-answer devices in development hint at an evolving molecular diagnostics landscape but launch timelines for these platforms remain unclear.
FDA Posts Info on Impact of SARS-CoV-2 Mutations on Test Effectiveness
The FDA identified molecular tests from Mesa Biotech, Applied DNA Sciences, Thermo Fisher Scientific, and Cepheid that could be affected by certain mutations.
Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
The firm sells a rapid, point-of-care, PCR platform for infectious disease diagnostics, including SARS-CoV-2, influenza, respiratory syncytial virus, and strep A.
FDA Issues Alert About Potential False Negative Test Results From SARS-CoV-2 Mutations
The agency identified three tests potentially impacted by known mutations, and said it will continue to monitor authorized assays.