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Lab capacity increasing but barriers remain for COVID-19 tests

Roadblocks like shortages of routine supplies could impede progress

Updated 5:24 p.m. | The Trump administration says diagnostic testing for the COVID-19 virus in the United States will soon reach the levels needed to manage the increasing number of cases here, but achieving that goal will depend a lot on how well private labs and the broader health care system function.  

On Friday, President Donald Trump announced that “drive-thru” testing locations would soon be available in the parking lots of major retailers like Walmart, Target, CVS and Walgreens. Starting Sunday night, Google will be offering a web form to assess people for symptoms and direct them to a testing location site.

Vice President Mike Pence acknowledged during a White House news conference that while doctors can order tests for any patient, not all Americans might have access to tests as labs prioritize those with the worst symptoms and those in contact with other patients. The drive-thru tests are meant to rectify that, he said in response to questions over whether everybody in the U.S. can now be tested.

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The Rose Garden announcement followed other developments that could expand testing capacity, including health care products company Roche Holdings AG announcing the availability of a new test that could increase private sector capacity.

The Food and Drug Administration also took steps Friday to speed testing in New York state, and the Health and Human Services Department announced new grants for two companies to develop more rapid tests. HHS also announced that Brett Giroir, the assistant secretary for health, would coordinate the testing response between the FDA, the Centers for Disease Control and Prevention and the broader health care system. 

But even as capacity increases, roadblocks like shortages of routine supplies could impede progress. 

“We’re concerned there could be challenges as we step up increased demand and screen more specimens,” said Julie Khani, president of the American Clinical Lab Association, who cited a potential lack of swabs as a barrier to conducting tests. 

Even with testing available, people may struggle to find proper guidance on whether and where they should be tested in a fragmented health care system the average person already has difficulty navigating. 

“Our health care system is at least as much of a barrier to coherent public health surveillance as politics is right now, and it continues to be a problem as we try to total up daily what is going on,” Tara O’Toole, a former undersecretary for science and technology at the Department of Homeland Security, said in a conference call hosted by the Council on Foreign Relations. 

[Top health official calls dearth of US coronavirus tests a ‘failing’]

Many public health experts view the U.S. testing capacity as too low compared with the scope of the problem, resulting in a likely undercount of the number of infected here. 

The CDC estimates that between public and private sector labs, there is the capacity for somewhere between 6,000 and 7,000 tests run per day, the agency said in response to questions from Rep. Mark Pocan, D-Wis. That translates into a smaller number of people being tested since individuals are tested multiple times to confirm infection. 

The CDC isn’t reporting how many tests have actually been conducted, but independent researchers running the COVID-19 Tracker website estimate that 14,000 people have been tested so far in the U.S.

An initiative by the conservative think tank American Enterprise Institute, run by former FDA Commissioner Scott Gottlieb, appears to be more comprehensive and shows greater capacity than the CDC projection, with an estimate that the U.S. capacity is slightly more than 25,000 patients per day as of Friday. 

President Donald Trump on Friday declared in a tweet that “testing will soon happen on a very large scale basis. All Red Tape has been cut, ready to go!”

His assertion followed several steps by HHS and the FDA that could have a positive effect on testing capacity, although experts say more is likely needed, and the U.S. is still weeks behind where it should be given the scale of the coronavirus pandemic here. 

A White House spokesman, Devin O’Malley, said Trump was referring to the FDA’s approval of a test that can be run on high-volume, rapid systems that many labs and hospitals already have, as well as some other actions announced Friday. 

The “cobas” system, by Roche, can provide test results in 3.5 hours, the company says. Two versions of the system are in use. One of them can process 1,440 results in 24 hours, and the other can process 4,128 results in 24 hours. There are more than 100 of these systems in the U.S., the company said, and hundreds more set up around the world. The company said this could allow for “millions of tests a month.”

The FDA authorized use of the test on an emergency basis late Thursday evening. On Friday, the agency said it had allowed the company to begin pre-positioning tests in labs throughout the country before the authorization was granted. The FDA also recently issued guidance for labs to use a CDC-developed test in platforms they already have on hand. 

“Very significant approval,” Gottlieb said in a tweet. “Will substantially increase patient testing capacity by end of next week by tens of thousands a day across all labs, commercial and academic.”

Those steps could help build private sector capacity, after the two largest lab companies in the U.S., Labcorp and Quest Diagnostics, started running tests that they developed in-house within the past week. 

The FDA also said Friday that it would essentially let the New York State Department of Health take over the authorization of new COVID-19 tests being developed in labs within the state. The FDA had previously given labs that designed their own tests the ability to start running them once validated internally and then notify the FDA within 15 days. However, New York labs will only have to report to the state health department, not the FDA. 

FDA Commissioner Stephen Hahn said in a statement that the decision “should expedite the availability of patient testing in New York state.”

It’s unclear if this approach would work in any state, however, as the FDA noted New York has a well-developed framework for oversight of lab-developed tests and the state public health lab has been accredited as a third-party reviewer of certain tests. 

HHS also announced Friday that the Biomedical Advanced Research and Development Authority would provide approximately $1.3 million to two companies — DiaSorin Molecular, LLC, of California and QIAGEN LLC of Maryland — to develop tests for existing diagnostic systems, similar to Roche’s approach. HHS said the tests would be capable of processing results in one hour, and that DiaSorin would likely be ready to submit to the FDA for authorization within six weeks and QIAGEN within 12 weeks.

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