FDA Broadens Hologic’s EUA for Aptima COVID-19 Test
The FDA has expanded the Emergency Use Authorization (EUA) it granted for Hologic’s Aptima COVID-19 assay back in May, now allowing the diagnostic to be used for testing patients without symptoms.
The company said the agency made its decision based on available analytical data and the company’s commitment to submit results from a clinical evaluation currently in progress. It received a similar EUA authorization last week for its Panther Fusion COVID-19 assay.
Hologic cited a recent FDA report showing that the company’s assays “are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market.”