Quest's Coronavirus Test Receives FDA Emergency Use Authorization In A First For Specimen Pooling

The Food and Drug Administration on Saturday reissued an emergency use authorization to Quest Diagnostics Inc’s DGX COVID-19 test that can be used with up to four samples at a time.

What Happened

The SARS-CoV-2 rRT-PCR, made by Quest, has become the first test to receive the FDA clearance for use with pooled samples, according to the federal agency. The approval will allow health workers to test more individuals faster using fewer resources, it added.

Hailing the usefulness of such tests, the National Institute of Allergy and Infectious Diseases Director Anthony Fauci said at a Senate hearing last month, “It’s a really good tool. It can be used in any of a number of circumstances, including at the community level or even in schools,” the Associated Press reported.

Why It Matters

Pooling samples could allow for a large number of people to be tested for COVID-19, thus allowing asymptomatic individuals to be covered in large test drives at schools or businesses, the Press noted.

The testing approach used by Quest’s kit is best used in areas where less than 10% of people are likely to test positive.

Companies such as 3M Co MMM are developing rapid test kits that can deliver COVID-19 diagnosis in minutes.

Price Action

Quest shares closed nearly 1.2% higher at $125.11 on Friday, and were unchanged in the after-hours session.

Photo credit: Governor Tom Wolf via Flickr.