The in vitro diagnostics industry has turned in an impressive response to the COVID-19 pandemic, but a few problems are bound to surface. The U.S. FDA reported May 10 that the Accula test by San Diego-based Mesa Biotech Inc. has been recalled due to contamination of test materials at the manufacturing site, a problem that could lead to false negative findings with the test.

Thermo Fisher Scientific Inc. has inked a definitive agreement to acquire Mesa Biotech Inc., a privately held molecular diagnostics company with a point-of-care (POC) platform, for approximately $450 million in cash. The scientific instruments and testing giant said it will pay an additional $100 million in cash upon the completion of certain milestones. The planned acquisition will expand Thermo Fisher’s franchise of diagnostic test options with a novel platform that enables nucleic acid polymerase chain reaction (PCR) testing at the point of care.

Reports of multiple new variants of the SARS-CoV-2 virus have emerged, raising questions about the efficacy of vaccines, but also regarding the utility of diagnostic and other tests. The U.S. FDA’s Tim Stenzel said single-target tests are thus at a greater risk of returning a false negative result, adding that these developers “should consider this carefully” in surveillance of their tests.