Two of the nation’s largest clinical testing providers are launching their own assays for the novel coronavirus—moving forward this week after the FDA gave high-tech labs the green light to operate tests before receiving any agency review or authorization.
LabCorp began making its internally developed PCR test available March 5, for use with respiratory samples such as saliva, washes, and nasal or oral swabs.
Meanwhile, Quest Diagnostics said it would begin offering its nationwide testing service March 9, using its lab-developed test designed to detect RNA of the virus known as SARS-CoV-2.
On February 29, the FDA loosened its policy to allow certain certified labs to immediately begin fielding validated coronavirus diagnostics, on the condition that they be presented for review within 15 days.
LabCorp said the FDA’s review of its test, currently pursuing an Emergency Use Authorization, is still pending—while Quest said it plans to submit its test and validation data to the agency within the mandated timeline.
"In times of national health crises, quality laboratory testing is absolutely critical to mobilizing effective public health response," said Quest’s chairman, president and CEO, Steve Rusckowski, who described how the company’s relationships with half of U.S. health systems and physicians could complement CDC efforts.
“We applaud the FDA for providing the flexibility for innovative, quality lab-developed tests to be brought to patients and providers quickly to advance effective response to the coronavirus outbreak," Rusckowski added.
Quest’s testing service will collect specimens from settings such as hospitals and clinics—not through its own network of patient service centers and phlebotomy sites.
Similarly, LabCorp is not collecting specimens through its own locations as well. The company said frozen samples should be sent from healthcare facilities via standard procedures, and estimated a result turnaround time of three to four days.
“We have been intensely focused on making testing for COVID-19 available as soon as possible, working with the government and others to address this public health crisis,” said LabCorp President and CEO Adam Schechter, who also described the vaccine and therapeutic research efforts underway under the company’s Covance drug development arm.
The U.S. government has been working to expand its own diagnostic capacity after previously routing testing through CDC labs, leading to delays in sample turnaround time. Additionally, reagent quality control issues in the three-step CDC test have also hindered the center’s efforts.
According to international public health organizations, as of late March 5, the U.S. has seen 215 confirmed cases of patients with the disease known as COVID-19, including 12 deaths in the states of Washington and California.
Editor’s note: This story has been updated with news from LabCorp.