Quest, awaiting expected FDA approval, estimates it can do 20K tests a day by end of month

Secaucus-based Quest Diagnostics said it is ramping up scale to combat COVID-19 and expects it will be able to perform 10,000 tests a day by the end of this week and 20,000 tests a day by the end of the month.

In a release send out Saturday, Quest said it has created a new lab-developed test for COVID-19. The test has not been cleared or approved or authorized by the Food & Drug Administration. Quest said the test has been validated according to CLIA, or clinical laboratory improvement amendments, but said the FDA’s independent review of this validation is pending.

Quest said the molecular test detects nucleic acid of the virus that causes COVID-19 in respiratory specimens. Quest said health care providers anywhere in the U.S. are now able to order this new test from Quest while it awaits approval.

Quest said it currently performs its COVID-19 lab-developed test at its Quest Diagnostics Infectious Disease laboratory in San Juan Capistrano, California. Quest said it hopes to “significantly expand testing” at several laboratories by the end of March, including one in Teterboro.

Quest stressed that it is not meeting with any individuals at its testing locations. Simply put, it does not collect samples, it tests those submitted.

“Providers should not refer any patient suspected of (being persons under investigation) or confirmed to be infected with COVID-19 to a Quest Diagnostics patient service center or other phlebotomy site,” Quest said int the release.

Gov. Phil Murphy, in a Sunday morning radio interview, said the state is eager to get more testing from private labs, specifically noting Quest.

“The good news, the folks who both collect the swabs and the folks who do the tests, the population of groups that do those are growing by the day,” he said. “And that’s a good thing.

“And the particular good news, on the testing side, the high-speed testers, which are private sectors players, folks like LabCorp and Quest Diagnostics, they can do hundreds if not thousands a day. We suffer a little bit in the data — and understanding real time who the folks are who test positive, negative or inconclusively — when it’s done by the private sector, as opposed to when it’s done by our own Department of Health but, frankly, that’s a price we’ll pay right now because we can much more rapidly and much more broadly test folks.”

Here is the media release by Quest, as it was sent out Saturday afternoon:

COVID-19 is a rapidly evolving situation. Here’s what we are doing:

Quest is working with other labs through our trade association, the American Clinical Laboratory Association (ACLA), to rapidly expand capacity across the country. As ACLA estimates in a media statement issued March 13, 2020, “once additional FDA-approved high-throughput testing is available on large diagnostic platforms next week, the industry expects its capacity to be increased to more than 20,000 tests per day. Assuming there are no delays or shortages of necessary materials and supplies, commercial capacity is expected to exceed 280,000 tests per week by April 1.”

We are rapidly expanding testing capacity, bringing up our new lab-developed test in our high-complexity laboratories in Chantilly, Virginia, and Marlborough, Massachusetts, the week of March 16. 

With an FDA-approved high-throughput test now available, we also expect to significantly expand testing at several regional Quest Diagnostics laboratories by the end of March. These additional laboratories are located in major cities, including Dallas; Teterboro; Miami; Los Angeles; Chicago; Kansas City; Pittsburgh; and Phoenix. Plus, the rollout of these tests in major cities means patients will have closer access to testing

With these two labs and our lab in California performing our COVID-19 lab-developed test and with testing with an IVD test kit, we anticipate that we will be able to perform 10,000 tests a day by the end of next week and 20,000 tests a day by the end of the month.

About the test: The Quest Diagnostics lab-developed test detects nucleic acid in respiratory specimens of patients meeting the clinical criteria of the U.S. Centers for Disease Control and Prevention (CDC) for COVID-19 testing. The test is performed on respiratory specimens collected by health care providers and forwarded to Quest Diagnostics. We report results of our COVID-19 testing to public health labs, consistent with guidelines.”

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