Hologic Aptima SARS-CoV-2 Assay’s FDA EUA Amended to Include COVID-19 Testing of Asymptomatic Individuals, Symptomatic Sample Pooling

Hologic, Inc.’s (Marlborough, MA, USA) Aptima SARS-CoV-2 assay, which had initially received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in May, has now been authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.

In addition, the FDA has authorized the company’s pooling protocol for symptomatic testing with the Aptima SARS-CoV-2 assay. The authorization follows a recent announcement of similar claims for Hologic’s Panther Fusion SARS-CoV-2 assay. The asymptomatic screening claim is based on available analytical data, including results published in a recent FDA report, as well as Hologic’s commitment to submit results from a clinical evaluation currently in progress. The FDA report showed that Hologic’s assays are the most analytically sensitive of the fully automated, high-throughput molecular tests on the market. The Aptima and Panther Fusion SARS-CoV-2 tests run on Hologic’s fully automated Panther and Panther Fusion systems, respectively, each of which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours.

“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,” said Kevin Thornal, president of the Diagnostic Solutions Division at Hologic. “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."