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

 
 

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Self-driving pizza delivery goes live in Houston

Domino's and Nuro announced their partnership in 2019 — and now the robots are hitting the roads. Photo courtesy of Nuro

After announcing their partnership to work on pizza deliveries via self-driving robots in 2019, Dominos and Nuro have officially rolled out their technology to one part of town.

Beginning this week, if you place a prepaid order from Domino's in Woodland Heights (3209 Houston Ave.), you might have the option to have one of Nuro's R2 robot come to your door. This vehicle is the first do deliver completely autonomously without occupants with a regulatory approval by the U.S. Department of Transportation, according to a news release.

"We're excited to continue innovating the delivery experience for Domino's customers by testing autonomous delivery with Nuro in Houston," says Dennis Maloney, Domino's senior vice president and chief innovation officer, in the release. "There is still so much for our brand to learn about the autonomous delivery space. This program will allow us to better understand how customers respond to the deliveries, how they interact with the robot and how it affects store operations."

Orders placed at select dates and times will have the option to be delivered autonomously. Photo courtesy of Nuro

The Nuro deliveries will be available on select days and times, and users will be able to opt for the autonomous deliveries when they make their prepaid orders online. They will then receive a code via text message to use on the robot to open the hatch to retrieve their order.

"Nuro's mission is to better everyday life through robotics. Now, for the first time, we're launching real world, autonomous deliveries with R2 and Domino's," says Dave Ferguson, Nuro co-founder and president, in the release. "We're excited to introduce our autonomous delivery bots to a select set of Domino's customers in Houston. We can't wait to see what they think."

California-based Nuro has launched a few delivery pilots in Houston over the past few years, including the first Nuro pilot program with Kroger in March 2019, grocery delivery from Walmart that was revealed in December 2019, and pharmacy delivery that launched last summer.

From being located in a state open to rolling out new AV regulations to Houston's diversity — both in its inhabitants to its roadways, the Bayou City stood out to Nuro, says Sola Lawal, product operations manager at Nuro.

"As a company, we tried to find a city that would allow us to test a number of different things to figure out what really works and who it works for," Lawal says on an episode of the Houston Innovators Podcast. "It's hard to find cities that are better than Houston at enabling that level of testing."

Steam the episode here.

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