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.

EverlyWell's online results will be available within 48 hours. EverlyWell/Facebook

Texas company first to launch at-home test for COVID-19

COVID-19 WATCH

As reports keep indicating a shortage of supply for COVID-19 tests around the country, a Texas startup has rolled out a new at-home test for consumers beginning today, March 23.

Everywell, which already offers an array of at-home lab tests, says 30,000 COVID-19 tests will be available in the initial batch. Free telehealth consultations will be provided for people who test positive for COVID-19, or the coronavirus.

As TIME first reported, this is the first U.S. company to offer at-home COVID-19 test kits directly to consumers.

"The extreme shortage of tests for COVID-19 puts millions of Americans at risk," Julia Cheek, founder and CEO of Everlywell, said in a March 18 release. "Everlywell is committed to helping stop the spread of COVID-19 in the U.S. by making this test widely available. As the national leader in at-home lab testing, we want to use our resources and expertise to help as many people as we can. We are committed to this fight, and we're here to help."

Working with a number of diagnostic labs, Everlywell plans to create testing and diagnosis capacity for 250,000 people per week.

Everlywell recently launched a $1 million program aimed at encouraging labs to fast-track development of an at-home COVID-19 diagnostic test. Many labs stepped up to the task, enabling Everlywell to create a COVID-19 testing and diagnosis infrastructure in a matter of days.

"Our team has been working around the clock with top scientists and laboratories in the nation to develop a test that we will make available at the lowest price possible while covering our costs, at no profit to the company," Cheek says. "We have also reached out to government and public health officials to explore possibilities to provide it for free."

Each test costs $135, and is covered by participating providers of health savings accounts and flexible spending accounts.

The test can be requested online by consumers experiencing COVID-19 symptoms. Samples can be collected at home, preventing further exposure for consumers and the public. All of Everlywell's lab partners conducting COVID-19 tests comply with the U.S. Food and Drug Administration's emergency rules for COVID-19 testing.

"Given the high demand for testing, the company will work rapidly to make more tests available as the global supply shortage for COVID-19 diagnostic kits is addressed," the company says.

Like Everlywell's other tests, the COVID-19 test will be shipped to customers with everything needed to collect a test sample at home and safely send that sample to a certified lab. Samples will be shipped to labs overnight, secure online results will be available within 48 hours of the lab receiving a sample, and a free telehealth consultation with an independent board-certified physician will provided to anyone who tests positive.

Anyone seeking a test will be asked to fill out an online screening questionnaire.

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This article originally ran on CultureMap.

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Houston family's $20M donation drives neurodegeneration research

big impact

Neurodegeneration is one of the cruelest ways to age, but one Houston family is sharing its wealth to invigorate research with the goal of eradicating diseases like Alzheimer’s.

This month, Laurence Belfer announced that his family, led by oil tycoon Robert Belfer, had donated an additional $20 million to the Belfer Neurodegeneration Consortium, a multi-institutional initiative that targets the study and treatment of Alzheimer’s disease.

This latest sum brings the family’s donations to BNDC to $53.5 million over a little more than a decade. The Belfer family’s recent donation will be matched by institutional philanthropic efforts, meaning BNDC will actually be $40 million richer.

BNDC was formed in 2012 to help scientists gain stronger awareness of neurodegenerative disease biology and its potential treatments. It incorporates not only The University of Texas MD Anderson Cancer Center, but also Baylor College of Medicine, Massachusetts Institute of Technology (MIT) and Icahn School of Medicine at Mount Sinai.

It is the BNDC’s lofty objective to develop five new drugs for Alzheimer’s disease and related disorders over the next 10 years, with two treatments to demonstrate clinical efficacy.

“Our goal is ambitious, but having access to the vast clinical trial expertise at MD Anderson ensures our therapeutics can improve the lives of patients everywhere,” BNDC Executive Director Jim Ray says in a press release. “The key elements for success are in place: a powerful research model, a winning collaborative team and a robust translational pipeline, all in the right place at the right time.”

It may seem out of place that this research is happening at MD Anderson, but scientists are delving into the intersection between cancer and neurological disease through the hospital’s Cancer Neuroscience Program.

“Since the consortium was formed, we have made tremendous progress in our understanding of the molecular and genetic basis of neurodegenerative diseases and in translating those findings into effective targeted drugs and diagnostics for patients,” Ray continues. “Yet, we still have more work to do. Alzheimer's disease is already the most expensive disease in the United States. As our population continues to age, addressing quality-of-life issues and other challenges of treating and living with age-associated diseases must become a priority.”

And for the magnanimous Belfer family, it already is.

3 Houston innovators to know this week

who's who

Editor's note: Every week, I introduce you to a handful of Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes a podcast with the founder of a new venture firm, a former astronaut and recent award recipient, and a health care innovator with fresh funding.

Zach Ellis, founder and managing partner of South Loop Ventures

Zach Ellis explains on the Houston Innovators Podcast that South Loop Ventures plans to invest in promising companies from across the country and bring them into Houston's ecosystem to grow and scale. Photo via LinkedIn

Houston has a lot of the right ingredients for commercialization and scaling up companies, so when Zach Ellis moved to town to stand up a venture capital firm that made investments in diverse founders, he decided to go about it in an innovative way.

South Loop Ventures, which Ellis launched two years ago, invests in pre-seed and seed-stage startups across health care, climatetech, aerospace, sports, and fintech. While the first handful of investments, which have already been made, are into Houston-based companies, Ellis explains on the Houston Innovators Podcast that the firm plans to invest in promising companies from across the country and bring them into Houston's ecosystem to grow and scale.

"Any investor wants to feel like they are looking at the best possible investment opportunities in which to deploy capital," Ellis says on the show. "So that's reason No. 1 to cast your net as widely as possible.

"At the same time, you want to give any investment that you make greatest chances of success," he continues. "The biggest factor of success outside of the team and the capital you give them, is the customers that they can call upon. In bringing targeted companies to Houston or connecting them with Houston, you introduce the opportunity for them to achieve rapid scale and work with world-class partners very efficiently." Read more.


Toby R. Hamilton, founder and CEO of Hamilton Health Box

Dr. Toby Hamilton has secured $10 million to grow his company. Photo via tmc.edu

A Houston company that is working on a value-based model for primary care has fresh funding to support its mission.

Hamilton Health Box announced the completion of a $10 million series A funding round led by 1588 Ventures with participation from Memorial Hermann Health System, Impact Ventures by Johnson & Johnson Foundation, Texas Medical Center Venture Fund, and the Sullivan Brothers.

The company, founded in 2019 by Dr. Toby R. Hamilton, will use the funding to fuel its expansion into rural areas to help assist those living in Health Professional Shortage Areas, or HPSAs. Read more.

Ellen Ochoa, former astronaut and center director at the NASA's Johnson Space Center

Ellen Ochoa was recognized for her leadership at NASA Johnson and for being the first Hispanic woman in space. Photo via NASA

Two astronauts recently received Presidential Medals of Freedom from President Joe Biden for their leadership in space.

Ellen Ochoa, the former center director and astronaut at the NASA's Johnson Space Center in Houston, and Jane Rigby, senior project scientist for NASA’s James Webb Space Telescope, were honored at the White House on May 3.

Ochoa spent 30 years with NASA, which included being the 11th director of JSC, deputy center director of JSC, and director of Flight Crew Operations. She served on the nine-day STS-56 mission aboard the space shuttle Discovery in 1993, and became the first Hispanic woman in space. She flew four more times to space with STS-66, STS-96, STS-110, and more.

“I’m so grateful for all my amazing NASA colleagues who shared my career journey with me,” Ochoa says in a NASA news release. Read more.

Houston health care institutions receive $22M to attract top recruits

coming to Hou

Houston’s Baylor College of Medicine has received a total of $12 million in grants from the Cancer Prevention & Research Institute of Texas to attract two prominent researchers.

The two grants, which are $6 million each, are earmarked for recruitment of Thomas Milner and Radek Skoda. The Cancer Prevention & Research Institute of Texas (CPRIT) announced the grants May 14.

Milner, an expert in photomedicine for surgery and diagnostics, is a professor of surgery and biomedical engineering at the Beckman Laser Institute & Medical Clinic at the University of California, Irvine and the university’s Chao Family Comprehensive Cancer Center

In 2013, Milner was named Inventor of the Year by the University of Texas at Austin. At the time, he was a professor of biomedical engineering at UT. One of his major achievements is co-development of the MasSpec Pen, a handheld device that identifies cancerous tissue within 10 seconds during surgical procedures.

Skoda is a professor of molecular medicine in the Department of Biomedicine at the University of Basel and the University Hospital Basel, both in Switzerland. He specializes in developing treatments for myeloproliferative neoplasms, which are a group of blood diseases including leukemia.

Other recruitment grants provided by the institute to Houston-area organizations are:

  • $4 million for recruitment of Susan Bullman to the University of Texas M.D. Anderson Cancer Center. She was an assistant professor at Seattle’s Fred Hutchinson Cancer Center, where she studied the connection between microbes and cancer.
  • $4 million for recruitment of Oren Rom to the University of Texas M.D. Anderson Cancer Center. Rom is an assistant professor of pathology and translational pathobiology at Louisiana State University Shreveport.
  • Nearly $2 million for recruitment of Lauren Hagler to conduct RNA cancer biology at Texas A&M University. She is a postdoctoral scholar in biochemistry at Stanford University.

The institute also awarded grants to five companies in the Houston area:

  • $4.7 million to 7 Hills Pharma for development of immunotherapies to treat cancer and prevent infectious diseases.
  • $4.5 million to Indapta Therapeutics for the Phase 1 trial of a cell therapy for treatment of multiple myeloma and non-Hodgkin’s lymphoma.
  • $2.75 million to Bectas Therapeutics for development of antibodies and biomarkers to overcome a type of resistance T-cell checkpoint therapy.
  • $2.69 million to MS Pen Technologies for development of technology that differentiates between normal tissue and cancerous tissue during surgery.
  • $2.58 million to Crossbridge Bio for development of an antibody-drug combination to treat certain solid tumors.