FDA Issues Emergency Authorization to Two More COVID-19 Diagnostic Tests

A nurse holds swabs and test tube to test people for COVID-19 at a drive through station set up in the parking lot of the Beaumont Hospital in Royal Oak Mich. Monday

"We strongly support FDA's decision to abolish its EUA requirements for COVID-19 testing, which will enable many more AACC member laboratories to offer these desperately needed tests", said AACC President Dr. Carmen L. Wiley.

"FDA grants an EUA for Roche's coronavirus test". We laboratory directors were on the spot to develop tests, and most were unprepared to say the least.

The agency also took steps toward speeding the development of coronavirus test kits by giving states the authority to approve tests developed in laboratories in the states. The EUA was issued within 24 hours of the FDA receiving the application, and since the test was pre-positioned, laboratories were able to immediately begin running tests upon authorization.

In response to a serious shortage of tests for detecting the fast-moving SARS-CoV-2 virus, the FDA is conferring new powers on states to authorize laboratories for the development of their diagnostic labs and has given approval to novel tests that will be distributed by two of the largest manufacturers- LabCorp (testing laboratory) and Hologic (medical devices company). This is because inaccurate diagnoses during a pandemic could worsen the effect of the preventive measures and delay appropriate treatment for the infected patients. The FDA is requiring that it be notified within 15 business days that such use is occurring, and that labs and vendors be transparent in how they validate the tests.


Finally, our updated policy provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers. The agency said that while serological tests are less complex than molecular tests and only identify antibodies, it does not intend to object to vendors developing these tests for SARS-CoV-2 infection.

The FDA has engaged with more than 100 test developers since the end of January, providing templates and advice about the EUA process.

For the most part, public health officials don't know who in the USA has it because there isn't a method to test most of the population for it. We don't often use this trope in medicine, but I can think of nothing better to describe what has been going on in the USA with the coronavirus outbreak. 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.

But to help address the urgent need for more tests, the U.S. Food and Drug Administration (FDA) announced an "unprecedented" move on Monday. The Secretary of the US Department of Health and Human Services determined on February 4, 2020, that COVID-19 was a public health emergency, and subsequently declared the circumstances justified the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19.

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