Azar Spells Out How Coronavirus Testing Will Ramp Up

Regulatory NewsRegulatory News | 05 March 2020 |  By 

As health officials have gone back and forth on the specifics of how many people may be tested for the novel coronavirus and what kind of testing capacity is available, HHS Secretary Alex Azar made clear on Thursday that hundreds of thousands will be able to be tested by the end of this week.

In a press conference, Azar outlined three stages to the availability for lab testing. First, he said, is the test that the Centers for Disease Control and Prevention (CDC) developed and received an emergency use authorization (EUA) from FDA for. CDC is sending that test, at no cost, to a little more than 70 public health labs, Azar said. The Association of Public Health Laboratories announced Thursday that 67 public health labs are currently verified and offering testing, which is up from only eight such labs a week ago.

With that CDC test, Azar said there is the capacity to test 15,000 people currently, and by the end of the week, the CDC will have shipped out enough tests to test 75,000 people.

What that means is that a doctor or hospital wishing to test someone for the coronavirus can work with these public health labs for testing, Azar said.

Meanwhile, Integrated DNA Technologies, which is working with CDC to get its own authorization to market that same CDC test, believes that by the end of the week, it’ll have sent out enough tests to test 1 million specimens, which would be the equivalent of testing about 400,000 people, Azar said. The company also thinks it can scale up production to about 4 million specimens in another week.

In addition, other commercial labs are working with the recently released guidance from FDA to develop their own tests and receive EUAs. Azar said such commercial labs could include LabCorp, Quest Diagnostics and others, and they will make the experience easier because doctors are used to working with these types of companies.

Quest said in a statement on Thursday that it will be in position to receive specimens for testing, and begin to provide testing next Monday, 9 March. “The new test service will be provided as a laboratory developed test, pending review by the FDA under emergency use authorization (EUA) which the company will submit per FDA guidance within 15 days of clinical testing. The test is a molecular based assay which detects viral RNA in respiratory specimens,” Quest said.

LabCorp also said Thursday that it is making its test available today, beginning at 6 p.m. ET, for physicians or other authorized health care providers anywhere in the US. The test detects the presence of the underlying virus that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.

But Azar also acknowledged the challenges with regard to testing for coronavirus right now, adding, “The experience will get better over the next few weeks.”

Meanwhile, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) re-introduced a bill on Thursday that seeks to better regulate the types of tests that are being used for the coronavirus. FDA has been calling for such reforms since at least 2014, with former FDA Commissioner Scott Gottlieb more recently explaining how the regulation of such diagnostics could be improved.


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