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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."

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