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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

 
 

Unlike past awards programs hosted by Ignite Healthcare Network, the Ignite Madness winners accepted their awards via video call. Photo courtesy of Ignite

From the comfort of their own homes, several female entrepreneurs accepted investment and pitch prizes at the finals of an inaugural awards program created by a Houston-based, woman-focused health organization.

Ahead of the Ignite Madness finals on Thursday, October 29, Houston-based Ignite Healthcare Network named nine finalists that then pitched for three investment prizes. The finalists included:

  • Eden Prairie, Minnesota-based Abilitech Medical — medical device company that creates assistive devices to aid those with upper-limb neuromuscular conditions or injuries.
  • New Orleans, Louisiana-based Chosen Diagnostics — a biotech company focusing on custom treatment. First, Chosen is focused on creating two novel biomarker diagnostic kits — one for gastrointestinal disease in premature infants.
  • San Francisco, California-based Ejenta — which uses NASA tech and artificial intelligence to enhance connected care.
  • Highland, Maryland-based Emergency Medical Innovation — a company focused on emergency medicine like Bleed Freeze, a novel device for more efficiently treating nosebleeds.
  • Columbia, Missouri-based Healium — an app to quickly reduce burnout, self-manage anxiety, and stress.
  • Farmington, Connecticut-based Nest Collaborative — digital lactation solutions and support.
  • Palo Alto, California-based Nyquist Data — a smart search engine to enable medical device companies to get FDA approvals faster.
  • New Orleans-Louisiana based Obatala Sciences — a biotech startup working with research institutions across the globe to advance tissue engineering and regenerative medicine.
  • Perth, Australia-based OncoRes — a company that's developing a technology to provide surgeons with real-time assessment of tissue microstructure.
The inaugural event that mixed health care and basketball — two vastly different industries with strong connections to women — attracted support from partners and sponsors, such as Intel, Accenture, Morgan Lewis, Houston Methodist, Johnson & Johnson Innovation, and more, according to Ayse McCracken, founder and board chair of Ignite.

"Our partners and sponsors are an integral part of our organization" says McCracken. "Without each and every one of them, the networks, resources, and commitment to advancing women leaders, we would not have grown so rapidly in just four years and our IGNITE Madness event would not enjoy this vibrant ecosystem that now surrounds female entrepreneurs."

First up in selecting their winner for their investment was Texas Halo Fund. Chosen Diagnostics took home the $50,000 investment.

"While we were impressed by everyone who pitched tonight, one company stood out to us," says Kyra Doolan, managing partner. "[Chosen Diagnostics] exemplifies what we are looking for: an innovative solution, a strong CEO, and a real addressable market."

The second monetary award was presented by Tom Luby, director of TMC Innovation. The award was an $100,000 investment from the TMC Venture Fund, as well as admission to TMCx. The recipient of the investment was OncoRes.

"We are absolutely blown away," says Katharine Giles, founder of Onco. "We've already got a great link to Texas and looking forward to more."

The largest monetary award that was on the table was presented by Wavemaker Three-Sixty Health, a leading Southern-California based, early stage venture capital firm, for $150,000. However, at the time of the announcement, Managing Partner Jay Goss decided to award four startups an undisclosed amount of investment. Goss says he and his team will meet with each company to establish an investment.
The companies that were recognized by Wavemaker were: Healium, Ejenta, Emergency Medical Innovation, and Nest Collaborative.
Lastly, Ignite itself had $27,500 cash awards to give out to the pitch competition winners. The funds will be distributed between the winners. OncoRes took first place, Abilitech came in second place, and Obatala Sciences took third place.

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