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Quest Diagnostics Gets First FDA EUA for SARS-CoV-2 Testing With Pooled Samples

NEW YORK ­– Quest Diagnostics and the US Food and Drug Administration announced on Saturday that the company received Emergency Use Authorization from the FDA to for the use of Quest's SARS-CoV-2 RNA test for pool sampling to detect the coronavirus.

The agency reissued an EUA to the Secaucus, New Jersey-based company for the test, which is the first to receive the designation for pooled sampling for COVID-19 testing.

Pooled sampling, which allows samples from multiple individuals to be tested simultaneously using one test, can save resources and can accelerate the testing process. The FDA, which provided guidance on pooled samples in June, said in a statement on Saturday that pooled sampling is "most efficient in areas with low prevalence, meaning most results are expected to be negative."

Pooled samples with negative test results are assumed to be negative for COVID-19 for all individuals comprising the batch. For pooled samples that are positive, each individual would need to be retested to determine which individual, or individuals, may have SARS-CoV-2.

Under the EUA granted to Quest, each sample pool will comprise four individuals. Quest's SARS-CoV-2 RNA test may be used with pooled upper respiratory specimens, including nasopharyngeal, mid-turbinate, anterior nares, or oropharyngeal swabs. The company noted that in clinical data presented to the FDA, none of the 3,091 total specimens from a population with a prevalence rate of 1 to 10 percent, if pooled, would have been incorrectly determined to be negative.

Quest expects to deploy the pooled sample technique at its laboratories in Chantilly, Virginia and Marlborough, Massachusetts by the end of next week with additional laboratories to follow.

"This EUA for sample pooling is an important step forward in getting more COVID-19 tests to more Americans more quickly while preserving testing supplies," FDA Commissioner Stephen Hahn said in a statement. "Sample pooling becomes especially important as infection rates decline and we begin testing larger portions of the population."

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