FDA gives Hologic EUA for SARS-CoV-2 test

By LabPulse.com staff writers

May 15, 2020 -- The U.S. Food and Drug Administration (FDA) gave Hologic emergency use authorization (EUA) for its Aptima SARS-CoV-2 molecular test for detection of the novel coronavirus.

The newly authorized test runs on Hologic's Panther system, which can provide initial results in approximately three hours and process more than 1,000 coronavirus tests in 24 hours, according to the company. Panther is already installed at more than 1,000 clinical laboratories throughout the U.S.

The Aptima SARS-CoV-2 assay was developed with support of a $13 million contract with the U.S. Biomedical Advanced Research and Development Authority, part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Hologic has begun distributing the product and expects to produce an average of one million tests per week. The company plans to register the Aptima SARS-CoV-2 assay for a CE Mark later this month.

Hologic also markets the Panther Fusion SARS-CoV-2 molecular test, which received an EUA from the FDA in March.

Industry roundup: Oncology dominates noncoronavirus IVD news
There's no doubt that COVID-19 tests remain a focal point for IVD research and development. But companies increasingly are announcing new non-COVID-19...
Hologic debuts research-use-only SARS-CoV-2 test
Hologic has launched a research-use-only version of a new molecular assay that can detect SARS-CoV-2 and which is expected to dramatically increase testing...
Hologic molecular test helps Quest avoid coronavirus backlog
Thanks in part to the use of a molecular test from Hologic, Quest Diagnostics has reported another increase in the volume of novel coronavirus diagnostics...
FDA hosts town hall on diagnostic testing for novel coronavirus
The U.S. Food and Drug Administration (FDA) will host a virtual town hall on March 25 for clinical laboratories and commercial manufacturers to discuss...
FDA issues EUA for LabCorp coronavirus test
The U.S. Food and Drug Administration (FDA) on March 16 issued an emergency use authorization (EUA) to LabCorp for the company's coronavirus testing kit.

Copyright © 2020 LabPulse.com

Last Updated ls 5/15/2020 2:13:33 PM



Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.
Email
Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current