CORONAVIRUS RESPONSE

Texas startup’s at-home COVID-19 test finally approved by feds

The at-home COVID-19 tests are now available. EverlyWell/Facebook

After its earlier effort was tripped up, Austin-based startup Everlywell on May 16 finally gained approval from the U.S. Food and Drug Administration to launch its at-home coronavirus test.

In a May 18 release, Everlywell says the self-administered test will be available later this month. The company, which specializes in at-home tests for an array of conditions, is the first to receive approval from the FDA for an at-home coronavirus test that's not associated with a lab or a manufacturer of diagnostic products.

The FDA's emergency authorization allows Everlywell to work with a number of certified labs that process authorized tests, rather than just a single lab.

"The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, says in a release.

Everlywell's at­-home test determines the presence or absence of the novel coronavirus, which causes COVID­-19 illness. Everlywell's test kit uses a short nasal swab and includes:

  • A digital screening questionnaire reviewed by a healthcare provider.
  • Instructions on how to ship the test sample to a lab.
  • Digital results within 48 hours of the sample being received by the lab.
  • Results reviewed by an independent physician.

Anyone who tests positive test will receive a telehealth consultation. All positive test results are reported to federal and local public health agencies when mandated.

On March 23, Everlywell was supposed to start shipping 30,000 coronavirus test kits to U.S. consumers. But before a single test was sent, the FDA blocked distribution of at-home, self-administered tests from Everlywell and other companies. After that, Everlywell pivoted to supplying coronavirus tests to health care providers and organizations.

As with the company's previously approved coronavirus test, Everlywell says its test for individuals is sold at no profit. The $109 price covers costs such as overnight shipping to a lab, lab-processing fees, and kit components. Some health insurers cover coronavirus tests.

Everlywell says it's working with members of Congress to enable companies that are neither healthcare providers nor labs to be directly reimbursed by health insurers. The startup also is exploring how its coronavirus test could be made available for free.

"Widespread access to convenient testing will play a crucial role in the country's ability to address the pandemic and prevent overburdening our healthcare facilities. As the national leader in connecting people with high­-quality laboratory testing, we are committed to fighting the spread of this virus in America," Julia Cheek, founder and CEO of Everlywell, says in the Everlywell release.

The company continues to supply its coronavirus tests to qualified healthcare organizations and government agencies.

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This article originally ran on CultureMap.

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Building Houston

 
 

Adrianne Stone has joined Capital Factory's Houston operations as the company prioritizes digital startup interaction. Photo courtesy of Capital Factory

For years, Capital Factory has existed to promote innovation and grow startups across Texas and has expanded from its headquarters in Austin to Dallas, Houston, and beyond. In light of COVID-19, the organization has pivoted to make sure it can work with startups remotely and online.

"I think Capital Factory has successfully embraced virtual first," says Bryan Chambers, vice president of the accelerator and fund at Capital Factory. "I think it's gone well and it feels like we're just hitting our stride."

Chambers admits that the onset of the coronavirus had a great effect on Capital Factory — SXSW being canceled did its damage on the organization, which has a huge presence every year. However, cross-state startup collaboration is the driving force behind Capital Factory's Texas Manifesto.

"We're one big state, and we're one big startup ecosystem," Chambers says. "The resources across Dallas, Houston, Austin, North Texas, and San Antonio are available for everybody. Candidly, COVID aligns with that. There's no better time — COVID is erasing the boundaries in a virtual world."

In addition to navigating the transition to virtual operations, Capital Factory has also introduced its newest Houston staff member, as Adrianne Stone has started this week as venture associate for the organization. Stone received her Ph.D in Translational Biology and Molecular Medicine from Baylor College of Medicine before heading out to the West Coast and working at 23andme. She brings both her experience with health tech and Silicon Valley to her position.

"The mindset in Silicon Valley is different from how it is here in Texas — in good ways and bad ways. It was interesting to be exposed to a very potent startup vibe," Stone tells InnovationMap. "I'm looking forward to being able to meet all the cool companies, founders, and investors we have here in the Houston area."

Stone replaces Brittany Barreto, who helped in coordinating her replacement and is staying on part-time for the rest of August to help with training and immersion into the ecosystem. Barreto, who is one of the founders of the recently launched startup masterclass Founder's Compass, has also introduced a new brand called Femtech Focus, that includes a podcast where she talks to innovators in the women's health and wellness space.

"I'm ready to get back into the founder's saddle," Barreto says, adding that there's more to come for Femtech Focus.

Throughout her tenure, Barreto has overseen Capital Factory's Houston portfolio companies — both identifying potential investment opportunities and connecting startups to resources and mentors. She passes the torch to her former BCM classmate, and says she's excited to do so to a fellow Ph.D.

"The last year and a half, I've working really hard on laying this foundation. I don't want all that hard work to go away, so I cared a lot about who was going to take my position," she says. "I wanted to make sure that all my founders had someone who cared about them as much as I do."

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