The Aptima SARS-CoV-2 assay from Hologic, Marlborough, Mass, which initially received FDA emergency use authorization (EUA) in May, is now authorized for testing of individuals without symptoms or other reasons to suspect covid-19 infection. This authorization follows a similar announcement from last week that Hologic’s Panther Fusion SARS-CoV-2 assay is also now authorized for testing of asymptomatic individuals.
The Centers for Disease Control and Prevention (CDC) recently issued guidance recommending covid-19 tests for people who have had recent contact with infected individuals, a key strategy for limiting the spread of the virus.
“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,” says 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.”
In addition, FDA authorized Hologic’s pooling protocol for symptomatic testing with the Aptima SARS-CoV-2 assay.
To date, Hologic has produced tens of millions of SARS-CoV-2 assays. 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 3 hours and process more than 1,000 coronavirus tests in 24 hours. More than 2,000 Panther and Panther Fusion systems have been installed in clinical diagnostic laboratories around the world.
For more information, visit Hologic.