FDA has granted emergency use authorization to Quest Diagnostics, Secaucus, NJ, 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. The method extracts RNA with the Mag-Bind Viral RNA Xpress Kit from Omega Bio-Tek, Norcross, Ga, using the MagEx Star from Hamilton Company, Reno, Nev.
“Laboratory innovation is key to optimizing testing capacity for covid-19,” says Steve Rusckowski, chairman, chief executive, and president of Quest Diagnostics. “We appreciate the collaboration of the FDA to bring this technique to several of our labs spanning the United States. 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 United States 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: San Juan Capistrano and Valencia, Calif; Lewisville, Texas; Lenexa, Kan; Chantilly, Va; and Marlborough, Mass.
Quest Diagnostics currently has the capacity to perform 135,000 covid-19 molecular diagnostic tests per day. The new method is expected to add an additional 35,000 tests per 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 expects to build additional capacity to 185,000 tests per day by Labor Day.
For more information, visit Quest Diagnostics.
Featured image: Quest Diagnostics lab technician in the company’s high-complexity lab in San Juan Capistrano, Calif.