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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Genies Wants To Help Creators Build ‘Avatar Ecosystems’

Christian Hetrick

Christian Hetrick is dot.LA's Entertainment Tech Reporter. He was formerly a business reporter for the Philadelphia Inquirer and reported on New Jersey politics for the Observer and the Press of Atlantic City.

Genies Wants To Help Creators Build ‘Avatar Ecosystems’

When avatar startup Genies raised $150 million in April, the company released an unusual message to the public: “Farewell.”

The Marina del Rey-based unicorn, which makes cartoon-like avatars for celebrities and aims to “build an avatar for every single person on Earth,” didn’t go under. Rather, Genies announced it would stay quiet for a while to focus on building avatar-creation products.

Genies representatives told dot.LA that the firm is now seeking more creators to try its creation tools for 3D avatars, digital fashion items and virtual experiences. On Thursday, the startup launched a three-week program called DIY Collective, which will mentor and financially support up-and-coming creatives.

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Here's What To Expect At LA Tech Week

Christian Hetrick

Christian Hetrick is dot.LA's Entertainment Tech Reporter. He was formerly a business reporter for the Philadelphia Inquirer and reported on New Jersey politics for the Observer and the Press of Atlantic City.

Here's What To Expect At LA Tech Week

LA Tech Week—a weeklong showcase of the region’s growing startup ecosystem—is coming this August.

The seven-day series of events, from Aug. 15 through Aug. 21, is a chance for the Los Angeles startup community to network, share insights and pitch themselves to investors. It comes a year after hundreds of people gathered for a similar event that allowed the L.A. tech community—often in the shadow of Silicon Valley—to flex its muscles.

From fireside chats with prominent founders to a panel on aerospace, here are some highlights from the roughly 30 events happening during LA Tech Week, including one hosted by dot.LA.

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PCH Driven: Director Jason Wise Talks Wine, Documentaries, and His New Indie Streaming Service SOMMTV

Jamie Williams
­Jamie Williams is the host of the “PCH Driven” podcast, a show about Southern California entrepreneurs, innovators and its driven leaders on their road to success. The series celebrates and reveals the wonders of the human spirit and explores the motivations behind what drives us.
Jason Wise holding wine glass
Image courtesy of Jason Wise

Jason Wise may still consider himself a little kid, but the 33-year-old filmmaker is building an IMDB page that rivals colleagues twice his age.

As the director behind SOMM, SOMM2, SOMM3, and the upcoming SOMM4, Wise has made a career producing award-winning documentary films that peer deep into the wine industry in Southern California and around the world.

On this episode of the PCH Driven podcast, he talks about life growing up in Cleveland as a horrible student, filmmaking, Los Angeles and his latest entrepreneurial endeavor: A streaming service called SOMMTV that features–what else?–documentaries about wine.

The conversation covers some serious ground, but the themes of wine and film work to anchor the discussion, and Wise dispenses bits of sage filmmaking advice.

“With a documentary you can just start filming right now,” he says. “That’s how SOMM came about. I got tossed into that world during the frustration of trying to make a different film, and I just started filming it, because no one could stop me because I was paying for it myself. That’s the thing with docs,” or “The good thing about SOMM is that you can explain it in one sentence: ‘The hardest test in the world is about wine, and you’ve never heard about it.’”

…Or at least maybe you hadn’t before he made his first film. Now with three SOMM documentaries under his belt, Wise is nearing completion of “SOMM4: Cup of Salvation,” which examines the history of wine’s relationship with religion. Wise says it’s “a wild film,” that spans multiple countries, the Vatican and even an active warzone. As he puts it, the idea is to show that “wine is about every subject,” rather than “every subject is about wine.”

For Wise, the transition to launching his own streaming service came out of his frustration with existing platforms holding too much power over the value of the content he produces.

“Do we want Netflix to tell us what our projects are worth or do we want the audience to do that?” he asks.

But unlike giants in the space, SOMMTV has adopted a gradual approach of just adding small bits of content as they develop. Without the need to license 500 or 1,000 hours of programming, Wise has been able to basically bootstrap SOMMTV and provide short form content and other more experimental offerings that typically get passed over by the Hulus and Disneys of the world.

So far, he says, the experiment is working, and now Wise is looking to raise some serious capital to keep up with the voracious appetites of his subscribers.

“Send those VCs my way,” Wise jokes.

Subscribe to PCH Driven on Apple, Stitcher, Spotify, iHeart, Google or wherever you get your podcasts.

dot.LA reporter David Shultz contributed to this report.

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