COVID-19 Diagnostic Tests Amended for Pooling and Serial Testing

Updates on RT-PCR molecular diagnostic tests for COVID-19 amended by the Pooling and Serial Testing Amendment.

If your email program has trouble displaying this email, view as a webpage. Update: COVID-19 Pooling and Serial Testing Amendment Exhibit 1 Today, the U.S. Food and Drug Administration (FDA) updated Exhibit 1 of the Pooling and Serial Testing Amendment to include: Clinical Research Sequencing Platform (CRSP), LLC at the Broad Institute of MIT and Harvard-CRSP SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Assay (Version 3) Biomeme Inc. SARS-CoV-2 Real Time RT-PCR Test Viracor Eurofins Clinical Diagnostics SARS-CoV-2 assay Tests authorized for SARS-CoV-2 that can be used for pooling, as part of a serial testing program under this amendment, are added to Exhibit 1 after the FDA confirms that the required documentation has been submitted by the test developer. Learn More Questions? If you have questions email COVID19Dx@fda.hhs.gov.

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