09 Apr 2020
Posted in Medical Devices
FDA’s new EUA guidance will make it easier for more coronavirus tests to enter market, says GlobalData
Following the US Food and Drug Administration’s (FDA’s) release for new emergency use authorization (EUA) guidance for laboratory developed coronavirus tests;
Dara Lo, Medical Device Analyst at GlobalData, a leading data and analytics company, offers her view:
“The gold standard for diagnosing COVID-19 is a common lab test using the polymerase chain reaction (PCR). While the FDA has worked with more than 270 coronavirus test developers, the protocol to run the COVID-19 PCR test is publicly available, and can be run in any lab that is properly equipped.
“Under the new FDA guidance, molecular-based laboratory developed tests for the qualitative (yes/no) detection of COVID-19 can be performed, as long as it is done in the CLIA-certified lab in which it was developed. This will incentivize the development of more reverse-transcriptase (RT)-PCR COVID-19 tests, and make it easier for developers to bring their test to market.
“The US is currently way under the testing capacity needed to effectively ‘flatten the curve’. The US testing rate is 3,605 tests per million people (as of 3 Apr), which is low in comparison to countries such as Germany, which is currently performing 8,063 tests per million people.
“The new EUA guidance from the FDA comes as a welcome relief as medical devices, such as diagnostic tests, usually face quite restrictive regulatory processes in order to come to market. This will ease access for laboratory developed tests, such as RT-PCR, which is the current gold standard of testing, to enter the market.
“There has been a lot of buzz about shifting to more rapid/point-of-care diagnostics, which would allow for faster turnaround times, and be able to be performed right in the doctor’s office (rather than waiting for the patient sample to be shipped off to a testing lab). But these antibody tests have been slow to enter the market and are facing lots of scrutiny over specificity and sensitivity so RT-PCR remains the testing standard.”