FDA grants EUA for COVID-19 molecular tests from various developers

May 18, 2020

The U.S. Food and Drug Administration (FDA) granted emergency use authorization to several developers of molecular tests, including Hologic’s high-throughput Aptima SARS-CoV-2 assay, according to the FDA’s website.

Separately, the FDA also granted EUA to GeneMatrix for its NeoPlex COVID 19 Detection Kit and Applied DNA Sciences for its Linea COVID-19 Assay Kit. Both test kits are designed to run on real-time PCR instruments.

Hologic’s Aptima SARS-CoV-2 assay runs on the company’s Panther system, which is a fully automated, high-throughput molecular diagnostic platform that can provide initial results in three hours and process more than 1,000 coronavirus tests in 24 hours.

In March, the FDA approved Hologic’s EUA application for the Panther Fusion SARS-CoV-2 test.

Hologic has received financial support for its coronavirus test-development efforts from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA).

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