Aptima received FDA emergency use authorization (EUA) in May as a COVID-19 test, and this week the FDA amended the EUA to include testing for asymptomatic individuals or those with other reasons to suspect COVID-19 infection, according to a news release.
Last week, Hologic received similar authorization for its Panther Fusion SARS-CoV-2 assay for testing asymptomatic people, following CDC guidance recommending tests for those who have come into recent contact with infected individuals.
Marlborough, Mass.-based Hologic said an FDA report showed that its assays are the most analytically sensitive of the fully automated, high-throughput molecular tests available, and the FDA also authorized its pooling protocol for symptomatic testing with Aptima.
“For many years, molecular tests – tests that directly detect the genetic material of pathogens – have been recognized as the gold standard for infectious disease diagnostics,” Hologic president of diagnostic solutions Kevin Thornal said in the release. “They remain the most sensitive and accurate available options, which is particularly important when screening individuals with no symptoms or known contact with infected people, and therefore no clues about their infectious state.”