FDA Warns About False Negatives in Curative's COVID Results

Francesca Billington

Francesca Billington is a freelance reporter. Prior to that, she was a general assignment reporter for dot.LA and has also reported for KCRW, the Santa Monica Daily Press and local publications in New Jersey. She graduated from Princeton in 2019 with a degree in anthropology.

FDA Warns About False Negatives in Curative's COVID Results
Ringo Chiu/ Shutterstock

The U.S. Food and Drug Administration is warning that a coronavirus test that Los Angeles officials have offered to tens of thousands of residents for free since spring can produce "the risk of false results, particularly false negative results."

The test is administered by Curative, which produces 10% of the nation's daily tests and has administered over 11 million tests. The company operates the largest testing site in the country at Dodger Stadium. The year-old company run by Fred Turner has grown quickly and acquired contracts with the Air Force. It also tests members of Congress and is used by several major cities.


To reduce the false results, the FDA warns to test "symptomatic individuals within 14 days of COVID-19 symptom onset."

But in Los Angeles and elsewhere, the company often tests non-symptomatic individuals. L.A. Mayor Eric Garcetti said he had hoped that making the tests widely available would reduce the spread of the virus. His office did not reply to repeated requests for comment.

The FDA did not indicate how frequently incorrect test results were produced, but according to Curative's own non-peer-reviewed studies, it has a false negative rate at around 10%.

Turner has argued that the rate is better than most of the nasal swab testing out there and oral tests, which can be self-administered, are the only way the country can reopen quickly.

But the FDA warns that false negative tests can lead to consequences like delayed treatment and lack of monitoring of infected individuals, which could lead to an increased risk of spreading the virus.

The agency said a negative result from Curative "does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions."

The Los Angeles company was originally created to detect sepsis but pivoted to COVID testing efforts early last year.

"We have been working with the agency to address their concerns and these limitations, and we will continue to work interactively with FDA through the Emergency Use Authorization process," Curative spokesman Pasquale Gianni said in an emailed statement.

He added: "Curative's test has been validated and is being offered during the pandemic under an Emergency Use Authorization, and is labeled with specific warnings, precautions, and limitations that FDA reiterated in the Safety Communication. The test performance and labeling, however, have not changed, nor has the company observed any changes in test performance."

In a press conference Thursday afternoon, Garcetti reiterated that the FDA's guidance does not impact the tests' use on symptomatic people, and defended the city's testing of asymptomatic individuals, saying that one-third of people who test positive for COVID are asymptomatic.

"This test is used by both symptomatic and asymptomatic people in countless jurisdictions, by the United States Congress, by NBA," he said. "Let's be clear about what the FDA said: For people with symptoms, they didn't issue any further guidance. It works. There's no issues. And that's been two thirds of all the tests."

He added that the false negative test rate in asymptomatic individuals is similar to other tests.

"What the FDA guidance says, like any test, is that you have to do it and use it correctly," he said. "So I'll remind people, if you're going to use this test, you have to cough, vigorously, three to five times."

It is unclear what prompted the warning from the FDA. Officials there did not respond to requests for comment, but it did not alter Curative's emergency use permit.

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LA Tech ‘Moves’: Saviynt Gains New CEO, The FIFTH Taps Agency Veteran to Lead Creative Team

Decerry Donato

Decerry Donato is a reporter at dot.LA. Prior to that, she was an editorial fellow at the company. Decerry received her bachelor's degree in literary journalism from the University of California, Irvine. She continues to write stories to inform the community about issues or events that take place in the L.A. area. On the weekends, she can be found hiking in the Angeles National forest or sifting through racks at your local thrift store.

LA Tech ‘Moves’: Saviynt Gains New CEO, The FIFTH Taps Agency Veteran to Lead Creative Team
LA Tech ‘Moves’:

“Moves,” our roundup of job changes in L.A. tech, is presented by Interchange.LA, dot.LA's recruiting and career platform connecting Southern California's most exciting companies with top tech talent. Create a free Interchange.LA profile here—and if you're looking for ways to supercharge your recruiting efforts, find out more about Interchange.LA's white-glove recruiting service by emailing Sharmineh O’Farrill Lewis (sharmineh@dot.la). Please send job changes and personnel moves to moves@dot.la.

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Samson Amore

Samson Amore is a reporter for dot.LA. He holds a degree in journalism from Emerson College and previously covered technology and entertainment for TheWrap and reported on the SoCal startup scene for the Los Angeles Business Journal. Send tips or pitches to samsonamore@dot.la and find him on Twitter @Samsonamore.

Los Angeles’ Wage Growth Outpaced Inflation. Here’s What That Means for Tech Jobs

Inflation hit cities with tech-heavy workforces hard last year. Tech workers fortunate enough to avoid layoffs still found themselves confronting rising costs with little change in their pay.

Those national trends certainly touched down in Los Angeles, but new data from the Bureau of Labor Statistics (BLS) show that the city of angels was the only major metro area that saw its wage growth grow by nearly 6% while also outpacing the consumer price index, which was around 5%. Basically, LA was the only area where adjusted pay actually came out on a net positive.

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samsonamore@dot.la

Energy Shares Wants to Offer You a Chance to Invest in Green Energy Startups

David Shultz

David Shultz reports on clean technology and electric vehicles, among other industries, for dot.LA. His writing has appeared in The Atlantic, Outside, Nautilus and many other publications.

Energy Shares Wants to Offer You a Chance to Invest in Green Energy Startups
Photo by Red Zeppelin on Unsplash

The Inflation Reduction Act contains almost $400 billion in funding for clean energy initiatives. There’s $250 billion for energy projects. $23 billion for transportation and EVs. $46 billion for environment. $21 billion for agriculture, and so on. With so much cash flowing into the sector, the possibilities for investment and growth are gigantic.

These investment opportunities, however, have typically been inaccessible for everyday retail investors until much later in a company’s development–after an IPO, usually. Meaning that the best returns are likely to be captured by banks and other institutions who have the capital and financing to invest large sums of money earlier in the process.

That’s where Pasadena-based Energy Shares comes in. The company wants to help democratize access to these investment opportunities and simultaneously give early-stage utility-scale energy projects another revenue stream.

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