FDA Amends Emergency Use Authorization for Hologic’s Aptima SARS-CoV-2 Assay

Aptima® SARS-CoV-2 Assay to Include COVID-19 Testing of Asymptomatic Individuals, Symptomatic Sample Pooling (Photo: Business Wire)
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Hologic, Inc. announced today that its Aptima® SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May, is now authorized for testing of individuals without symptoms or other reasons to suspect COVID-19 infection.


This authorization follows an announcement last week of similar claims for Hologic’s Panther Fusion® SARS-CoV-2 assay. The U.S. 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.1


“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."


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.


In addition, FDA authorized the company’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, thereby making a significant contribution to the global testing supply. 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. More than 2,000 Panther and Panther Fusion systems have been installed in clinical diagnostic laboratories around the world.


This press release features multimedia. View the full release here

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Published on : Tue, 6 Oct 2020



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Hologic, FDA, Food and Drug Administration, Coronavirus, COVID-19, SARS-CoV-2, Emergency Use Authorization, SARS-CoV-2 virus, SARS-CoV-2 assay, EUA, COVID-19 infection, Panther®, Panther Fusion systems, Aptima® SARS-CoV-2 assay, Aptima® Hologic, Inc. announced today that its Aptima® SARS-CoV-2 assay, which initially received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) in May, is now authorized for testing of individuals without symptoms or other rea

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