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FDA Declines APHL Request to Make Own SARS-CoV-2 Test Kits

NEW YORK – The US Food and Drug Administration declined Wednesday to grant the Association of Public Health Laboratories' request for enforcement discretion regarding laboratory-developed tests for the novel coronavirus SARS-CoV-2.

FDA said in a letter to APHL that all tests for the virus must pass through the agency's Emergency Use Authorization process, but noted that were the APHL or its members to take a test through that process it could be "authorized under a single EUA for use across multiple public health laboratories."

The APHL on Monday asked the FDA to exercise enforcement discretion, which would have allowed public health laboratories to develop and implement their own tests for the virus without taking them through FDA, rather than relying on the test developed by the Centers for Disease Control and Prevention.

The request came in response to problems with certain of the reagents in the rRT-PCR test developed by the CDC for detecting the virus. The issue has limited rollout of the test in public health labs around the country.