Dive Brief:
- LabCorp is immediately making available a test for the novel coronavirus, the company announced before the market closed Thursday. The news came hours after Quest Diagnostics said it will begin offering a testing service on Monday.
- Developments from the United States' mega-clinical labs come less than a week after FDA decided to allow lab developed tests, or LDTs, to begin assessing people for the SARS-CoV-2 virus prior to receiving emergency use authorization (EUA) from the agency.
- Separately, the bipartisan Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 was introduced Thursday, which would "among other things, make that change permanent," a related press release said.
Dive Insight:
Although numerous diagnostics makers are in various stages of developing tests for the rapidly spreading virus, introduction of testing services from LabCorp and Quest represents new potential scale in screening for the illness in the U.S.
“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,” CEO Adam Schechter said in a statement.
LabCorp said its test, a qualitative assay using PCR, was validated for use with respiratory samples. Actual specimens should be collected at a healthcare facility and then sent to LabCorp, which expects to return results within three to four days. The tests were available for healthcare providers to order as of Thursday at 6 p.m. Eastern Time.
Similarly, Quest said it will begin offering its molecular-based assay on Monday, which is meant to detect viral RNA in respiratory specimens, on samples collected at hospitals and physician sites and sent to Quest.
"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," CEO Steve Rusckowski said in a statement Thursday.
Both LabCorp and Quest intend to submit EUA applications to the agency, which FDA requires within 15 days of clinical testing.
The swath of patients that LabCorp and Quest can reach now extends to any patient with a doctor's order, per Centers for Disease Control and Prevention criteria updated this week.
LabCorp and Quest were part of an industry meeting with Vice President Mike Pence on Wednesday where execs from Thermo Fisher, Abbott, Mayo Clinic Laboratories, the American Clinical Laboratory Association (ACLA) and others convened to discuss coronavirus test development and capacity.
LabCorp and Quest received praise from former FDA Commissioner Scott Gottlieb.
LabCorp and Quest and other large commercial labs are also stepping in to do #coronavirus screening with their substantial capacity. These large platforms are great national assets and their contribution at a critical juncture is going to make a difference. https://t.co/vOZcxb1qPB
— Scott Gottlieb, MD (@ScottGottliebMD) March 5, 2020
FDA's number of EUAs remains at three as of late Thursday, for diagnostic tests from CDC and the New York Department of Health, and for certain respirators not typically allowed for use in healthcare settings.
Amid the LDT-friendly move this week by FDA, Reps. Diana DeGette, D-Colo., and Larry Bucshon, R.-Ind., introduced legislation Thursday that would permanently remove the pre-approval requirement for diagnostic tests during national emergencies.
In response to the bill's introduction, ACLA said in a statement Thursday its priorities remain to have "reform that recognizes" distinction between diagnostics and medical devices, and lab developed tests and in vitro diagnostics; and having "grandfather and transition policies" that maintain accessibility of already available lab tests.
