“The EUA pathway … has served for Ebola and Zika, etc.,” says Mark Miller, the chief medical officer at bioMérieux, an infectious-disease diagnostic company based in France. “And then you have a situation like now with coronavirus, which I don't think any of us have ever lived through.”
Margaret Hamburg, who served as the FDA commissioner from 2009 to 2015, told me that while she doesn’t have knowledge of what went on inside the FDA over the past few months, the agency could have proactively reached out to different national and international labs to see whether their tests could be approved for use in the U.S. For example, the FDA might ask a lab, “Would you be interested to try to redirect what you were doing for a MERS diagnostic to a novel-coronavirus diagnostic?” she says. Instead, as The New York Times reported, federal officials told one Seattle infectious-disease expert, Helen Chu, to stop testing for the coronavirus entirely. (In an email, an FDA spokesperson denied that the agency acted slowly. Ensuring the validity of tests is important, she noted, to prevent false results.)
It looks like Chu was not alone. Dozens of labs in the U.S. were eager to make tests and willing to test patients, but they were hamstrung by regulations for most of February, even as the virus crept silently across the nation.
Hard-to-Get Virus Samples
Labs and companies need samples of the virus itself in order to make their tests, but delays in getting access to samples further slowed down the test-development process. The coronavirus originated in China, and as several microbiologists told me, the Chinese government does not allow specimens to be shipped outside its borders.
Many researchers have had difficulty getting their hands on samples even as the virus has spread. “I was working the phones to try to get access to the virus,” Greninger said.
BioMérieux just released three versions of its coronavirus test this week, after beginning work on it on January 23. Miller says that with every viral outbreak, the company’s biggest problem by far is getting access to virus and patient specimens so that it can validate its tests. Even when working with nonauthoritarian countries, a combination of government processes, researcher reticence, complex shipping regulations, and patient-privacy concerns makes getting samples difficult for diagnostic companies like his.
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Miller said it would help if researchers, governments, and companies firmed up pathogen-sharing contracts in advance of an outbreak, but so far that hasn’t happened. “The problem is that in the past, industry has been viewed as this dirty participant in all of this, and we can't be trusted, and why would I have contracts with you?” Miller says. “But that’s ignoring the plain fact that we’re the ones that create the product in the end.”