FDA Authorizes Quest Diagnostics COVID-19 Diagnostic Testing for Specimen Pooling for Emergency Use


Quest Diagnostics, the world’s leading provider of diagnostic information services, announced that it has received emergency use authorization (EUA) from the U.S. FDA to use specimen pooling with its proprietary molecular diagnostic test for COVID-19. Quest is the first lab provider to receive FDA authorization for the technique for COVID-19 testing in the United States.

In pooling, specimens must still be collected into individual vials, but then are combined into small batches or pools by the laboratory. A negative result for a batch means that all patients in that pool are considered negative (If a positive result occurs for the batch, each specimen is retested individually). The technique is an efficient way to evaluate patients in regions or populations with low rates of disease. Pooling is used routinely in blood banking to screen donated blood for a variety of viruses, among other applications.

With the new pooling EUA, the Quest Diagnostics SARS-CoV-2 RNA (“Quest SARS-CoV-2 rRT-PCR”) test* may be used with pooled upper respiratory specimens (nasopharyngeal, mid-turbinate, anterior nares or oropharyngeal swabs). **In clinical data presented by Quest to the FDA, none of 3,091 total specimens from a population with a prevalence rate of 1-10 percent, if pooled, would have been incorrectly determined to be negative (95%CI 0.0-0.1%).

The company expects to deploy the technique at its laboratories in Chantilly, VA and Marlborough, Mass., by the end of next week with additional laboratories to follow.

“As COVID-19 continues to spread around the country, access to timely, quality laboratory testing is critical to patients and an effective public health response,” said Steve Rusckowski, Chairman, CEO and President, Quest Diagnostics. “Pooled specimen testing is a proven technique that will help us to optimize testing capacity at this critical time for our country.”

“We applaud FDA for taking this important step to empower Quest to increase capacity across our national laboratory network,” said Jay G. Wohlgemuth, M.D., Senior Vice President and Chief Medical Officer, Quest Diagnostics. “Pooling will help expand testing capacity but it is not a magic bullet, and testing times will continue to be strained as long as soaring COVID-19 test demand outpaces capacity. Each of us can practice behaviors that will reduce COVID-19 infections in our communities, so our national healthcare system can better respond to this crisis.”

FDA EUAs for Telemedicine Self-Collection
Yesterday, the FDA also granted three emergency use authorizations to Quest Diagnostics for the use of its Quest Diagnostics Self-Collection Kit with the Hologic Panther Fusion, Hologic Aptima and Roche cobas molecular platforms. The new EUAs expand the use of the self-collection kit beyond the EUA, granted on May 27th, for the use of the kit on the Quest SARS-CoV-2 rRT-PCR test. The company expects the new EUAs will allow it to use self-collection more broadly on behalf of clients and patients in the United States. Self-collected specimens that were not observed by a healthcare professional are not eligible for pooling.

About Quest Diagnostics 
Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, our diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve health care management. Quest annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our 47,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives.