The firm said its rapid antigen test provided 97.3 percent sensitivity and 99.6 percent specificity in clinical studies, and it is developing a saliva-based version.
Hologic intends to invest in assay development for Mobidiag's Novodiag PCR platform, which provides high-level multiplexing to detect infectious disease organisms.
The firm said it has licensed an instrument-free rapid immunoassay from an undisclosed test manufacturer that has received FDA Emergency Use Authorization.
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.
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.
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.
