Quest Diagnostics and LabCorp have rolled out a new COVID-19 coronavirus test service. Both new tests were introduced after the FDA issued a new policy in late-February allowing certain laboratories to develop a diagnostic test for the disease which is currently sweeping the globe.
“We believe this policy strikes the right balance during this public health emergency,” FDA Commissioner Stephen M. Hahn, MD, says in a news release announcing the policy. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S.”
As of the morning of March 9, about 545 confirmed cases of the virus have been reported in the U.S. where four states have declared emergencies, according to The New York Times.
Meanwhile four countries in Europe saw their number of new cases of the virus double in the past few days and patients can be found in at least 95 countries, The Times says.
The development also follows the relaxing of CDC rules for who could be tested for the virus. Previously, testing was limited to patients who had traveled from one of the infected countries. Now decisions on testing should be based on the local epidemiology of the virus and the clinical course of illness, according to the CDC.
The LabCorp test became available March 5 after the company, working with the government, focused on making the test, according to a news release announcing the availability.
“By expanding access to testing in the U.S., and preparing to support the development of vaccines and treatments for COVID-19 through our Covance Drug Development business, we are delivering on LabCorp’s mission to improve health and improve lives,” Adam H. Schechter, president and CEO of LabCorp says in the release.
The Quest Diagnostics test is expected to use respiratory specimens to be tested in a molecular based assay which will detect viral RNA, according to a news release about the rollout.
"In times of national health crises, quality laboratory testing is absolutely critical to mobilizing effective public health response," Steve Rusckowski, chairman, CEO, and president of Quest Diagnostics, says in the 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 United States.”