Some of the nation’s best academic laboratories wanted to begin developing their own coronavirus diagnostic tests early last month, but were blocked by federal rules about test development.
Why it matters: The U.S. is woefully behind in mass deployment of tests to detect coronavirus, determine its spread and isolate hot spots. Once given the go-ahead to develop tests under more relaxed terms, some of these labs were able to get tests up and running in a matter of days.
Even though their testing capacity is usually limited, academic labs are particularly crucial to coronavirus testing because they’re attached to hospitals. That means that providers treating patients at these hospitals can receive tests results much more quickly than those who have to send samples to commercial, state or CDC labs.
- Part of the overall problem with testing right now isn’t just that there aren’t enough tests available, but also that there can be long delays in determining whether patients are infected or not.
“They followed the standard process, but what needed to be in vision was that this was a once in a generation pathogen — a once in a generation epidemic,” former FDA Commissioner Scott Gottlieb told me.
The approval process for the academic labs highlights the clash between bureaucracy — which is in place for a reason — and the need to move quickly in the face of an emerging pandemic.
- “I do understand the FDA’s viewpoint, which is there’s really a need to standardize testing and make sure test results are accurate,” said Charles Chiu, associate director of the University of California at San Francisco Clinical Microbiology Laboratory. But “this is something that probably should have been discussed from the get go when we first knew about the outbreak in China.”
Yes, but: Less than a dozen academic labs are currently running tests, although others have said they’re working on developing them.
- The FDA posted relaxed testing guidelines on Feb. 29. Major commercial labs — like LabCorp and Quest — and smaller, non-academic private labs have also gotten tests prepared for operation since the announcement, in addition to academic labs — a total of more than 30 private labs, per the FDA. 16 were testing patients as of yesterday.
- State public health labs are also running tests, but like the CDC and commercial labs, aren’t directly connected with care sites.
- “The spread of the virus — it basically outstripped the guidance provided by the FDA,” Chiu said.
The other side: “In the U.S., we have policies in place that strike the right balance during public health emergencies of ensuring critical independent review by the scientific and public health experts and timely test availability,” FDA Commissioner Stephen Hahn said in a speech earlier this month..
- “The CDC test is a high-quality test, and it’s important to remember that false negatives or positives can be detrimental to making sure we are treating patients early, without delay, and also not quarantining healthy individuals.”
How it happened: Benjamin Pinsky, Medical Director of the Clinical Virology Laboratory at Stanford, told me that his lab began working on a test in early February, following the FDA guidelines at the time. After the FDA posted its more relaxed guidance, it took the lab only days to validate its test.
- “We were waiting for the FDA to make a decision about how they would handle clinical laboratory testing,” Pinsky said. “My goal was to be prepared as soon as they were ready to allow clinical labs to start testing.”
- Stanford got permission to begin testing on March 2 and began doing so on March 4. By the end of the day, Santa Clara County had already confirmed 14 cases, meaning that community spread was already underway.
The lab in San Francisco asked in early February if it could develop its own lab test under less extreme requirements, but the FDA said that the lab would have to instead go through the more stringent emergency use authorization process, per regulation.
- “We were trying to submit a clinical [lab-developed test] or develop a clinical [test] for [emergency-use authorization] approval, and the issue with it was it was delayed and that was because the FDA’s requirements were quite stringent,” Chiu said. “The FDA was making it too laborious…it would take too long to actually get approval.”
- And at that point, with the more severe requirements in place, the lab felt that it would make more sense to wait for commercial labs to develop tests rather than creating their own.
- “I think that it would have been helpful had some of the new guidance come out earlier so that laboratories would have had more time, whereas now we’re scrambling to meet demand,” Chiu said.
And on the East Coast, Karen Carroll, director of the Division of Medical Microbiology at Johns Hopkins, said that her lab had tried to get the CDC testing kit, but was denied access.
- “The CDC said we were not a public health laboratory and they were only making the kits available to public health” labs, Carroll said. It was eventually discovered that the kits weren’t working.
- The lab eventually made its own test after the requirements were relaxed. It took four days.
As reported by the New York Times, the University of Washington had also wanted to develop its own test, and around mid-February, grew frustrated with the FDA’s process.
The bottom line: As of yesterday, the U.S. has the capacity to test about 22,000 people a day, although it's unclear how many people are actually being tested. South Korea — which has a significantly smaller population — is testing nearly 20,000 people a day, the BBC reports.