An EUA enables unapproved medical products or unapproved uses of medical products to be used in an emergency when there are no adequate, approved, and available alternatives. Roche's test also is authorized for use in CLIA labs performing moderate complexity tests.
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).
On March 16, FDA updated its guidance on COVID-19 testing to allow clinical labs to create and perform COVID-19 tests without pursuing FDA emergency use authorization (EUA).
At this time, the CDC recommends that all healthcare providers use their judgment to determine if a person needs a test. Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection.
We know that people want to know the current numbers of tests in the field and how many patients are being tested.
The agency stated that serological tests are less complex as compared to molecular diagnostics further highlighting that FDA does not aim to object to the unreviewed applications of serological tests, providing they have been authenticated and comprise warning statements mentioning that they should not be considered as the only way of identifying a COVID-19 infection.
Labs don't have to send the CDC samples of their coronavirus test results anymore to get confirmation of positive cases thanks to an FDA policy change effective as of yesterday. More than 80 developers have sought our assistance with development and validation of tests they plan to bring through the EUA process.
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. 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.
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 FDA is also responsible for the safety and security of electronic radiation-emitting products, food supply, cosmetics, dietary supplements and even for the regulation of tobacco-based products.