Quest Joins COVID-19 Detection Fight with New Assay

Quest Diagnostics joins the growing number of firms that have developed tests for the coronavirus (COVID-19) in recent weeks. The Secaucus, NJ-based company said it was launching its COVID-19 test service that aids in the presumptive detection of nucleic acid in respiratory specimens of patients meeting Centers for Disease Control and Prevention clinical criteria. The diagnostics firm said its test is a molecular-based assay that detects viral RNA in respiratory specimens. Quest said it will be in a position to receive specimens for testing and begin to provide testing Monday, March 9. The company said the new test service will be provided as a laboratory-developed test, pending review by FDA under emergency use authorization (EUA) which the company will submit per the agency’s guidance within 15 days of clinical testing. "In times of national health crises, quality laboratory testing is absolutely, critical to mobilizing effective public health response," Steve Rusckowski chairman, president and CEO, Quest Diagnostics, said in a release. "Quest's national scale, diagnostic expertise and innovation, and relationships with half the country's physicians and health systems is a vital complement to the efforts of the CDC and other public health labs to contend with a growing number of suspected COVID-19 cases in the U.S. We applaud FDA for providing the flexibility for innovative, quality lab-developed tests to be brought to patients and providers quickly to adv...
Source: MDDI - Category: Medical Devices Tags: IVD Source Type: news