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

CORONAVIRUS RESPONSE

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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Houston hospital names leading cancer scientist as new academic head

new hire

Houston Methodist Academic Institute has named cancer clinician and scientist Dr. Jenny Chang as its new executive vice president, president, CEO, and chief academic officer.

Chang was selected following a national search and will succeed Dr. H. Dirk Sostman, who will retire in February after 20 years of leadership. Chang is the director of the Houston Methodist Dr. Mary and Ron Neal Cancer Center and the Emily Herrmann Presidential Distinguished Chair in Cancer Research. She has been with Houston Methodist for 15 years.

Over the last five years, Chang has served as the institute’s chief clinical science officer and is credited with strengthening cancer clinical trials. Her work has focused on therapy-resistant cancer stem cells and their treatment, particularly relating to breast cancer.

Her work has generated more than $35 million in funding for Houston Methodist from organizations like the National Institutes of Health and the National Cancer Institute, according to the health care system. In 2021, Dr. Mary Neal and her husband Ron Neal, whom the cancer center is now named after, donated $25 million to support her and her team’s research on advanced cancer therapy.

In her new role, Chang will work to expand clinical and translational research and education across Houston Methodist in digital health, robotics and bioengineered therapeutics.

“Dr. Chang’s dedication to Houston Methodist is unparalleled,” Dr. Marc L. Boom, Houston Methodist president and CEO, said in a news release. “She is committed to our mission and to helping our patients, and her clinical expertise, research innovation and health care leadership make her the ideal choice for leading our academic mission into an exciting new chapter.”

Chang is a member of the American Association of Cancer Research (AACR) Stand Up to Cancer Scientific Advisory Council. She earned her medical degree from Cambridge University in England and completed fellowship training in medical oncology at the Royal Marsden Hospital/Institute for Cancer Research. She earned her research doctorate from the University of London.

She is also a professor at Weill Cornell Medical School, which is affiliated with the Houston Methodist Academic Institute.

Texas A&M awarded $1.3M federal grant to develop clean energy tech from electronic waste

seeing green

Texas A&M University in College Station has received a nearly $1.3 million federal grant for development of clean energy technology.

The university will use the $1,280,553 grant from the U.S. Department of Energy to develop a cost-effective, sustainable method for extracting rare earth elements from electronic waste.

Rare earth elements (REEs) are a set of 17 metallic elements.

“REEs are essential components of more than 200 products, especially high-tech consumer products, such as cellular telephones, computer hard drives, electric and hybrid vehicles, and flat-screen monitors and televisions,” according to the Eos news website.

REEs also are found in defense equipment and technology such as electronic displays, guidance systems, lasers, and radar and sonar systems, says Eos.

The grant awarded to Texas A&M was among $17 million in DOE grants given to 14 projects that seek to accelerate innovation in the critical materials sector. The federal Energy Act of 2020 defines a critical material — such as aluminum, cobalt, copper, lithium, magnesium, nickel, and platinum — as a substance that faces a high risk of supply chain disruption and “serves an essential function” in the energy sector.

“DOE is helping reduce the nation’s dependence on foreign supply chains through innovative solutions that will tap domestic sources of the critical materials needed for next-generation technologies,” says U.S. Energy Secretary Jennifer Granholm. “These investments — part of our industrial strategy — will keep America’s growing manufacturing industry competitive while delivering economic benefits to communities nationwide.”

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This article originally appeared on EnergyCapital.

Biosciences startup becomes Texas' first decacorn after latest funding

A Dallas-based biosciences startup whose backers include millionaire investors from Austin and Dallas has reached decacorn status — a valuation of at least $10 billion — after hauling in a series C funding round of $200 million, the company announced this month. Colossal Biosciences is reportedly the first Texas startup to rise to the decacorn level.

Colossal, which specializes in genetic engineering technology designed to bring back or protect various species, received the $200 million from TWG Global, an investment conglomerate led by billionaire investors Mark Walter and Thomas Tull. Walter is part owner of Major League Baseball’s Los Angeles Dodgers, and Tull is part owner of the NFL’s Pittsburgh Steelers.

Among the projects Colossal is tackling is the resurrection of three extinct animals — the dodo bird, Tasmanian tiger and woolly mammoth — through the use of DNA and genomics.

The latest round of funding values Colossal at $10.2 billion. Since launching in 2021, the startup has raised $435 million in venture capital.

In addition to Walter and Tull, Colossal’s investors include prominent video game developer Richard Garriott of Austin and private equity veteran Victor Vescov of Dallas. The two millionaires are known for their exploits as undersea explorers and tourist astronauts.

Aside from Colossal’s ties to Dallas and Austin, the startup has a Houston connection.

The company teamed up with Baylor College of Medicine researcher Paul Ling to develop a vaccine for elephant endotheliotropic herpesvirus (EEHV), the deadliest disease among young elephants. In partnership with the Houston Zoo, Ling’s lab at the Baylor College of Medicine has set up a research program that focuses on diagnosing and treating EEHV, and on coming up with a vaccine to protect elephants against the disease. Ling and the BCMe are members of the North American EEHV Advisory Group.

Colossal operates research labs Dallas, Boston and Melbourne, Australia.

“Colossal is the leading company working at the intersection of AI, computational biology, and genetic engineering for both de-extinction and species preservation,” Walter, CEO of TWG Globa, said in a news release. “Colossal has assembled a world-class team that has already driven, in a short period of time, significant technology innovations and impact in advancing conservation, which is a core value of TWG Global.”

Well-known genetics researcher George Church, co-founder of Colossal, calls the startup “a revolutionary genetics company making science fiction into science fact.”

“We are creating the technology to build de-extinction science and scale conservation biology,” he added, “particularly for endangered and at-risk species.”

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