Quest Diagnostics has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its new laboratory method to increase the Covid-19 molecular diagnostics capacity.
The new laboratory technique has been designed to expedite the process of extracting viral RNA from specimens, in addition to enhancing the daily capacity of Covid-19 molecular diagnostic tests on behalf of patients in the US.
The FDA EUA status enables six of the firm’s US laboratories to use the new RNA extraction method, including on pooled specimens.
Quest’s laboratories are located in San Juan Capistrano and Valencia of California, Lewisville of Texas, Lenexa of Kansas, Chantilly of Virginia and Marlborough of Massachusetts.
The new extraction technique is suitable for use with Quest SARS-CoV-2 rRT-PCR test
The new extraction technique is suitable to be used with the Quest SARS-CoV-2 rRT-PCR test, which is validated by the company for use on respiratory specimens from individuals suspected of Covid-19 by their healthcare provider.
The method enables to extract RNA with the Mag-Bind Viral RNA Xpress Kit (Omega Bio-Tek) and the Hamilton MagEx STAR, said the company.
At present, the company has the capacity to conduct 135,000 Covid-19 molecular diagnostic tests per day. The new method is anticipated to add an additional 35,000 tests per day.
Quest Diagnostics chairman, chief executive and president Steve Rusckowski said: “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.”
Recently, the company secured FDA EUA status for sample pooling in the diagnostic testing of Covid-19.
