FDA Quest lab method, Authorization Could Raise Daily Test Capacity.
Quest Diagnostics (NYSE:DGX) today announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for a new laboratory technique that speeds the process of extracting viral RNA from specimens* and will enable the company to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients in the United States.
“Laboratory innovation is key to optimizing testing capacity for COVID-19,” said Steve Rusckowski, Chairman, Chief Executive and President, Quest Diagnostics. “We appreciate the collaboration of the FDA to bring this technique to several of our labs spanning the U.S. With more testing capacity, we expect to improve turnaround times for our customers and patients.”
With the new FDA EUA, five of the company’s laboratories in the U.S. may now run this new RNA extraction method, including on pooled specimens. Those laboratories are well situated geographically to address high testing demand in states where the virus has been surging. The labs are in San Juan Capistrano and Valencia, California; Lewisville, Texas; Lenexa, Kansas; Chantilly, Virginia; and Marlborough, Massachusetts.
In its submission to the FDA, the company explained that “the method is needed to address availability of extraction supplies and increase testing capacity.”
The company currently has the capacity to perform 135,000 COVID-19 molecular diagnostic tests a day. The new method is expected to add an additional 35,000 tests a day in overall capacity over the next several weeks. In addition, the company will be able to use specimen pooling with the new method to increase capacity even further.
Consequently, Quest now expects to have the capacity to perform 150,000 tests per day by next week and to continue to build additional capacity beyond that to 185,000 tests per day by Labor Day. Quest expects this innovation will help it to achieve average turnaround times of 1 day for “Priority 1” patients and 2-3 days for all other patients in coming weeks.**
The new extraction technique may be used with the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real Time RT-PCR (Quest SARS-CoV-2 rRT-PCR), a proprietary test developed and validated by Quest Diagnostics for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. On July 17, the FDA granted an EUA for the test to be used with pooled specimens.***
Quest Diagnostics is a leader in infectious disease testing services, with a broad menu of molecular, antibody, and other test services to aid diagnosis, treatment and monitoring. The new FDA EUA follows several others received by the company for its COVID-19 test innovations.
*The method extracts RNA with the Mag-Bind Viral RNA Xpress Kit (Omega Bio-Tek) and the Hamilton MagEx STAR.
**Turnaround time for molecular diagnostic and antibody testing includes the time to transport a specimen to a Quest Diagnostics laboratory after collecting it at a patient service center or provider site to reporting results. Turnaround time can fluctuate with demand and vary by region. Priority 1 patients include hospital patients, pre-operative patients in acute care settings and symptomatic healthcare workers. We rely on the healthcare provider to indicate the level of priority of each patient specimen referred to us for testing.
***The Quest Diagnostics molecular test and self-collection kit have not been FDA cleared or approved, have been authorized by FDA under an EUA, and have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The test and self-collection kit are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.