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FDA Issues EUA for Point-of-Care COVID-19 PCR Test

FDA maze of regulations
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EUA issued for point-of-care COVID-19 test that provides results in 30 minutes, while using PCR technology

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) Feb. 8, 2021, for a point-of-care (POC) test that uses polymerase-chain reaction (PCR) technology. Visby Medical Inc.’s rapid PCR COVID-19 test had previously received an EUA, but the earlier EUA restricted use of the test to moderate-complexity CLIA-certified laboratories. This made point-of-care use very difficult.

Visby Medical’s rapid PCR COVID-19 test is a single-use test that is very compact for a PCR-based test. Palm-sized, the test can be used to provide COVID-19 test results within 30 minutes, according to the company. The test uses PCR technology, allowing it to be more accurate than antigen-based POC tests.

Advancing Visby’s PCR test, a new EUA for the “personal” PCR test expands its use to patient care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation, making POC use possible.

“This latest authorization will have a dramatic impact on COVID-19 testing, especially in situations when an accurate result is needed quickly,” said Gary Schoolnik, MD, in a company statement. Schoolnik is Chief Medical Officer at Visby Medical and Professor of Medicine at Stanford University.

“Visby’s test can now be used directly at the point of care with our most vulnerable populations, including nursing homes; for frontline health workers; to maintain patient care at places like cancer and dialysis treatment centers; and to the many schools and institutions that have undertaken the process to become CLIA-waived environments,” said Schoolnik.

As of Feb. 12, 2021, 327 tests and sample collection devices have been authorized by the FDA under EUAs, according to an FDA update. These include 243 molecular tests and sample collection devices, 70 antibody tests, and 14 antigen tests. There are 35 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.

Related Resources:

FDA EUA Letter: Visby Medical COVID-19


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