New FDA Virus-Test Policy Could Boost Availability, But Reduce Reliability

Thomas M. Burton and Sharon Terlep, Wall Street Journal: March 17, 2020

WASHINGTON—A federal agency’s decision to allow lab companies to release coronavirus tests without prior government approval should help ease the shortage of test kits, but at the potential cost of compromised results, medical experts said Tuesday.

“It’s a pretty good idea to allow for companies to get tests out in a national emergency,” said Paul Fey, research medical director at the University of Nebraska Medical Center. But he added that “these tests may not perform as well.”

The new policy was announced late Monday by Food and Drug Administration Commissioner Stephen Hahn, who conceded there were risks but said they were warranted by the circumstances.

Efforts to combat the virus have suffered from a shortage of test kits, which has typically required people with symptoms of the disease to get permission from a doctor for testing.

At the same time, however, inaccurate tests create their own set of problems, medical experts say.

False-negatives, in which a person is deemed healthy while actually sick, could mean that person infects others unwittingly. But a false-positive test is also problematic, as it could lead healthy people to end up in the hospital, wasting medical resources.

“It is not scientifically valid to just say ‘What the hell’ and let tests indiscriminately onto the market,” said Diana Zuckerman, president of the National Center for Health Research. “It does a lot of harm if the test isn’t accurate.”

Ravi Thadhani, chief academic officer at Partners HealthCare, a group of Boston-area hospitals that includes Harvard teaching hospitals, said “the likelihood is much higher” of such misleading results with the FDA decision.


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