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

 
 

Ty Audronis founded Tempest Droneworx to put drone data to work. Photo courtesy of Tempest Droneworx

Ty Audronis quite literally grew up in Paradise. But the Northern California town was destroyed by wildfire in 2018, including Audronis’ childhood home.

“That’s why it’s called the Campfire Region,” says the founder, who explains that the flames were started by a spark off a 97-year-old transmission line.

But Audronis, who has literally written the book on designing purpose-built drones — actually, more than one — wasn’t going to sit back and let it happen again. Currently, wildfire prevention is limited to the “medieval technology” of using towers miles apart to check for smoke signals.

“By the time you see smoke signals, you’ve already got a big problem,” Audronis says.

His idea? To replace that system with real-time, three-dimensional, multi-spectral mapping, which exactly where his company, Tempest Droneworx, comes in.

When asked how he connected with co-founder Dana Abramowitz, Audronis admits that it was Match.com — the pair not only share duties at Tempest, they are engaged to be married. It was a 2021 pre-SXSW brainstorming session at their home that inspired the pair to start Tempest.

When Audronis mentioned his vision of drone battalions, where each is doing a specialized task, Abramowitz, a serial entrepreneur and founder who prefers to leave the spotlight to her partner, told him that he shouldn’t give the idea away at a conference, they should start a company. After all, Audronis is a pioneer in the drone industry.

“Since 1997, I’ve been building multicopters,” he says.

Besides publishing industry-standard tomes, he took his expertise to the film business. But despite its name, Tempest is a software company and does not make drones.

That software is called Harbinger. Audronis explains that the real-time management and visualization solution is viewable on practically any device, including mobile or augmented reality. The system uses a video game engine for viewing, but as Audronis puts it, “the magic happens” on the back end.

Harbinger is not just drone-agnostic, but can use crowd-sourced data as well as static sensors. With the example of wildfires in mind, battalions can swarm an affected area to inform officials, stopping a fire before it gets out of hand. But fires are far from Harbinger’s only intended use.

The civilian version of Harbinger will be available for sale at the end of 2023 or beginning of 2024. For military use, Navy vet Audronis says that the product just entered Technical Readiness Level (TRL) 5, which means that they are about 18 months away from a full demo. The latest news for Tempest is that earlier this month, it was awarded a “Direct to Phase II” SBIR (Government Small Business Innovation Research) contract with the United States Department of the Air Force.

Not bad for a company that was, until recently, fully bootstrapped. He credits his time with the Houston Founder Institute, from which he graduated last February, and for which he now mentors, with many of the connections he’s made, including SBIR Advisors, who helped handle the complex process of getting their SBIR contract.

And he and Abramowitz have no plans to end their collaborations now that they’re seeing growth.

“Our philosophy behind [our business] isn’t keeping our cards close to our vest,” says Audronis. “Any potential competitors, we want to become partners.”

The company was just the two founders until five weeks ago, when Tempest’s size doubled, including a full-time developer. Once Tempest receives its SIBR check, the team will grow again to include more developers. They are currently looking for offices in the city. As Audronis says, Tempest Droneworx is “100-percent made in Houston.” Paradise may have been lost, but with Harbinger soon to be available, such a disaster need never happen again.

Dana Abramowitz and Ty Audronis co-founded Tempest Droneworks. Photo courtesy of Tempest Droneworx

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