FDA grants an EUA for Roche's coronavirus test 17 March 2020

Nor will these laboratories pursue an Emergency Use Authorization (EUA) with the FDA. There is a lot of confusion and misinformation about prevention, symptoms, and what to do if you suspect you have contracted the virus or come into contact with someone who has tested positive for novel coronavirus. In addition, more than 30 laboratories have notified FDA that they are testing, or intend to begin testing soon, laboratory developed tests (LDTs) for COVID-19.

The company had earlier made its COVID-19 detection kits available to a batch of certified labs following a change in the FDA's policy on February 29, allowing labs that met a set of standards known as the Clinical Laboratory Improvement Amendments (CLIA), to use coronavirus detection tests that have been developed and validated before the FDA had reviewed their Emergency Use Authorization (EUA) submission. FDA may issue an EUA to permit the use of certain medical products that are not approved in emergency situations to diagnose, treat, or prevent a disease or condition. The agency believes that a 15-period should be sufficient to prepare an EUA filing.

Finally, our updated policy provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. Roche Molecular System's cobas SARS-CoV-2 test was authorized on March 12, 2020, becoming the third COVID-19 diagnostic test, and first commercially distributed test, granted an EUA.

The next time there's an outbreak, we laboratory directors won't be waiting for the government to give us the green light to develop diagnostic tests.

We are updating frequently asked questions for labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs and more. If you don't know who has a disease, it's impossible to predict its spread, how many people will get it, or how many people may die from it. The association is actively working with legislators to correct this oversight, which could result in patients getting billed for COVID-19 testing and could continue to deter labs from performing these tests.

The FDA has recognized the urgent need for more testing.

The FDA continues to maintain operations 24/7 and we are here to support laboratories and test developers as they distribute tests through the country during this time of urgent need.

The Food and Drug Administration is a regulatory agency within the U.S. Health and Human Services Department that is engaged in protecting the public health and well-being by ensuring the safety, effectiveness, as well as security of both human and veterinary medications, vaccines and other biological formulations for use in human and medical devices.