Regulators Acted Slowly as Labs Developed Tests for Coronavirus

Amid early outbreak in Seattle, officials shut down one research lab’s test for SARS-CoV-2 virus

WHEN THE FIRST DEATHS FROM THE NOVEL CORONAVIRUS were reported in Seattle beginning on Feb. 29, Helen Chu, MD, MPH, took notice. An infectious disease expert at the University of Washington School of Medicine, Chu is a director with the Seattle Flu Study. Since late last year, researchers for the study have collected 2,500 flu samples from Seattle residents.

On Feb. 25, Chu and her colleagues at the Seattle Flu Study started testing patients for the SARS-CoV-2 virus that causes the COVID-19 illness, but just over one week later, state regulators told Chu and her colleagues on March 9 to stop testing to identify patients with coronavirus infections, The New York Times reported. The laboratory was not CLIA-certified, as other publications explained.

Also, the flu study should not be repurposed to test for the coronavirus, the Times wrote, because it was a research project that lacked the requisite permission from the research subjects. “While acknowledging the ethical questions, Dr. Chu and others argued there should be more flexibility in an emergency during which so many lives could be lost,” the Times added.

The reporting in the Times and elsewhere on Chu’s efforts to develop a test to identify COVID-19 in patients became fodder for a debate about harms of overregulation of testing in this setting.

“What should have been allowed was for the research study to continue testing for the flu while a CLIA-certified lab, such as the University of Washington, could use the flu study’s test to identify patients with coronavirus,” explained Roger D. Klein, MD, JD, a former adviser to the FDA and a faculty fellow at the Center for Law, Science and Innovation at the Sandra Day O’Connor School of Law.

As the Times explained, Chu and a team of researchers asked state and federal officials for permission to repurpose the study’s flu test to identify the coronavirus but were denied. Despite the denial, the researchers began performing the coronavirus test on Feb. 25 without government approval, the Times reported.

Laboratory Regulation

Pathologists and clinical lab directors will recognize the issue, because as Klein explained, the lab was not CLIA-certified and therefore was violating federal law by testing patients for clinical purposes.

“There are good reasons to have regulator oversight of clinical testing, but research studies fall outside this framework,” he added. “Although conceptually this is a form of regulation, the basis is a Congressionally-enacted statute. “The Times conflated or confused regulations governing clinical laboratories with regulations governing a research lab,” he said in an interview with The Dark Report. “The two kinds of labs are very different entities. It was disappointing that the coverage didn’t provide greater clarification on those differences.”

While the distinction between regulation of research and clinical lab testing was an issue in the Seattle case, there was another issue related to regulation—or in this case, overregulation of lab-developed tests—that caused needless delays in testing nationwide, Klein charged.

“The FDA’s prohibition against LDTs that academic medical centers, community hospitals, and health systems could have used to test for COVID-19 harmed our capacity to address the outbreak,” he said. “The prohibition potentially contributed to the deaths in Washington State and elsewhere and impaired our ability to recognize the extent to which community spread of SARS-CoV-2 had occurred.

“That action stands in stark contrast to what happened during the H1N1 epidemic in 2009, when hospital laboratories set up their own tests,” Klein added. “Those labs responded rapidly, and that fast action provided important information for both patient management and epidemiologic use.”

In an op-ed Klein wrote for City Journal, which the Manhattan Institute publishes, Klein wrote, “It’s troubling that community spread of the novel coronavirus in Washington State and other parts of the United States—possibly affecting hundreds to thousands of individuals—wasn’t detected sooner.

“Overregulation of diagnostic testing has played a major role in this delay,” he added. “For weeks, the CDC operated the nation’s sole diagnostic laboratory for coronavirus, while testing in the rest of the world proceeded apace.”

PCR Protocols Published

As we reported, researchers in China published protocols in January to use polymerase chain reaction (PCR) to test for the virus. (See “Northwell Lab Team Validates COVID-19 Test on Fast Timeline,” TDR, March 9, 2020.)

Since early February, the World Health Organization (WHO) has shipped more than 250,000 tests to 159 laboratories worldwide after replicating a procedure developed in a lab in Berlin, Germany, to create a test kit, Klein explained.

On March 11, Bloomberg Businessweek reported that the German lab, TIB Molbiol Syntheselabor GmbH, produced 40,000 coronavirus diagnostic kits—enough for about four million individual tests. The kits sell for €160 (or $180) and orders poured in from WHO, national health authorities, and laboratories in 60 countries, tripling the lab’s revenue in February over what it reported for the same month last year.

In China, health authorities approved 10 different manufacturers’ test kits by Feb. 23 to boost weekly production capacity to 1.65 million tests, Klein wrote in his op-ed. “Meantime, South Korea has more than 500 testing sites reportedly testing 10,000 individuals per day.”

A Slow Response

In contrast, according to the CDC, labs in the US had performed only 472 tests by March 2, he added. “Historically, FDA regulation has been confined to manufactured and distributed test kits,” he commented. “The agency has had little to no role in regulating clinical laboratories or the tests they develop and implement.

“CLIA-certified labs have significant oversight,” he commented. “They’re not regulated by FDA and we don’t have evidence of widespread or systemic problems from the tests these labs introduce. “The FDA should have continued the policy it pursued during the H1N1 outbreak in 2009,” Klein said. In 2014, the FDA set forth a framework for regulating LDTs in proposed guidance that was withdrawn after the November 2016 elections. The previous March, the FDA sent warning letters to labs that developed assays during the Zika outbreak in 2016. (See “At FDA, Laboratory-Developed Tests Are in the Crosshairs,” TDR, March 21, 2016.)

Contact Roger D. Klein, MD, JD, at 203-927-0257 or


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