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.

Everlywell says it will prioritize giving its at-home COVID-19 tests to healthcare professionals. Photo by Siri Stafford/Getty Images

Texas startup provides COVID-19 home-testing kits at no cost to medical professionals

now testing

The on-again, off-again launch of a coronavirus test from Austin startup Everlywell is on again — sort of.

On March 23, Everlywell was supposed to start shipping 30,000 test kits to U.S. consumers. But before a single test was sent, the U.S. Food and Drug Administration (FDA) blocked the distribution of at-home, self-administered tests from Everlywell and other companies.

Now, the Austin-based company is making the tests available primarily to hospitals and other healthcare providers in the U.S. to meet a "desperate need" for front-line medical professionals to be tested.

"In this evolving health crisis, our highest priority is to ensure that the people at highest risk get the accurate testing and care they need," Michelle Davey, CEO of Wheel Health, says in a March 23 release.

Everlywell says that effective March 23, its test is available only to hospitals and healthcare providers that offer it at no cost to their front-line workers, along with high-risk patients who exhibit coronavirus symptoms.

The company, which produces a variety of at-home lab tests, says its shift from testing of consumers to testing of healthcare workers and high-risk patients is "critically important" to help prevent the spread of what's known as the novel coronavirus. The virus causes the highly contagious and potentially deadly COVID-19 respiratory illness.

It's been a confusing few days since Everlywell announced it was making at-home tests for consumers. On March 20, the FDA said it hadn't authorized at-home, self-administered coronavirus tests from Everlywell or any other company. Three days later, on March 23, Dr. Deborah Birx, coronavirus coordinator for the White House, announced the federal government was clearing the way for self-swabbing coronavirus tests such as those made by Everlywell.

In a series of tweets March 23, Everlywell said it's working with the FDA on "a path forward" for at-home coronavirus tests of consumers.

"The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection," the federal agency says, "and we are actively working with test developers in this space."

Everlywell unveiled a $1 million program design to spur labs to speed up development of an at-home coronavirus diagnostic test. Many labs answered the call, allowing Everlywell to set up a coronavirus testing and diagnosis system in a matter of days. For consumers, each test will cost $135. Some providers of health savings accounts and flexible spending accounts will cover these tests.

Eventually, Everlywell wants to ship 250,000 tests per week.

At the same time, another Austin startup, Wheel Health, and Houston-based Microdrop have unveiled a partnership that will provide at-home coronavirus testing administered by licensed healthcare professionals, rather than consumers themselves, and supported by telemedicine technology. The federally approved product is geared toward people at high risk of the coronavirus or people with limited access to testing. For now, it's available only in Texas.

The test from Wheel, a telehealth provider, and Microdrop, a producer of at-home health tests, also costs $135. At the outset, the companies will roll out 5,000 test kits in Texas. After that, they plan to sell 10,000 test kits per week. Nationwide, the companies hope to offer 100,000 test kits per week by the end of April.

"Providing accurate medical guidance to people who are concerned about, or may have been exposed to, COVID-19 will determine the way this pandemic plays out in our country — and collaboration is essential to mobilizing toward this common goal rapidly and efficiently," says Dr. Rafid Fadul, chief medical officer of Wheel.

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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5 incubators and accelerators fueling the growth of Houston startups

meet the finalists

Houston is home to numerous accelerators and incubators that support founders in pushing their innovative startups and technologies forward.

As part of our 2025 Houston Innovation Awards, the new Incubator/Accelerator of the Year category honors a local incubator or accelerator that is championing and fueling the growth of Houston startups.

Five incubators and accelerators have been named finalists for the 2025 award. They support startups ranging from hard-tech companies to digital health startups.

Read more about these organizations below. Then join us at the Houston Innovation Awards on Nov. 13 at Greentown Labs, when the winner will be unveiled.

Get your tickets now on sale for this exclusive event celebrating Houston Innovation.

Activate

Hard tech incubator Activate supports scientists in "the outset of their entrepreneurial journey." The Houston hub was introduced last year, and joins others in Boston, New York, and Berkley, California—where Activate is headquartered. It named its second Houston cohort this summer.

This year, the incubator grew to include its largest number of concurrent supported fellows, with 88 companies currently being supported nationally. In total, Activate has supported 296 fellows who have created 236 companies. Those companies have raised over $4 billion in follow-on funding, according to Activate. In Houston, it has supported several Innovation Awards finalists, including Solidec, Bairitone Health and Deep Anchor Solutions. It is led locally by Houston Managing Director Jeremy Pitts.

EnergyTech Nexus

Cleantech startup hub EnergyTech Nexus' mission is to accelerate the energy transition by connecting founders, investors and industrial stakeholders and helping to develop transformative companies, known as "thunderlizards."

The hub was founded in 2023 by CEO Jason Ethier, Juliana Garaizar and Nada Ahmed. It has supported startups including Capwell Services, Resollant, Syzygy Plasmonics, Hertha Metals, EarthEn Energy and Solidec—many of which are current or past Innovation Awards finalists. This year Energy Tech Nexus launched its COPILOT Accelerator, powered by Wells Fargo Innovation Incubator (IN²) at the National Renewable Energy Laboratory (NREL). COPILOT partners with Browning the Green Space, a nonprofit that promotes diversity, equity and inclusion (DEI) in the clean energy and climatech sectors. Energy Tech Nexus also launched its Liftoff fundraising program, its Investor Program, and a "strategic ecosystem partnership" with Greentown Labs.

Greentown Labs

Climatetech incubator Greentown Labs offers its community resources and a network to climate and energy innovation startups looking to grow. The collaborative community offers members state-of-the-art prototyping labs, business resources and access to investors and corporate partners. The co-located incubator was first launched in Boston in 2011 before opening in Houston in 2021.

Greentown has seen major changes and activity this year. In February, Greentown announced Georgina Campbell Flatter as its new CEO, along with a new Board of Directors. In July, it announced Lawson Gow as its Head of Houston, a "dedicated role to champion the success of Greentown Houston’s startups and lead Greentown’s next chapter of impact in the region," according to Greentown. It has since announced numerous new partnerships, including those with Energy Tech Nexus, Los Angeles-based software development firm Nominal, to launch the new Industrial Center of Excellence; and Houston-based Shoreless, to launch an AI lab onsite. Greentown Houston has supported 175 startups since its launch in 2021, with 45 joining in the last two years. Those startups include the likes of Hertha Metals, RepAir Carbon, Solidec, Eclipse Energy (formerly GoldH2) and many others.

Healthtech Accelerator (TMCi)

The Healthtech Accelerator, formerly TMCx, focuses on clinical partnerships to improve healthcare delivery and outcomes. Emerging digital health and medical device startups that join the accelerator are connected with a network of TMC hospitals and seasoned advisors that will prepare them for clinical validation, funding and deployment.

The Healthtech Accelerator is part of Texas Medical Center Innovation, which also offers the TMCi Accelerator for Cancer Therapeutics. The Healthtech Accelerator named its 19th, and latest, cohort of 11 companies last month.

Impact Hub Houston

Impact Hub Houston supports early-stage ventures at various stages of development through innovative programs that address pressing societal issues. The nonprofit organization supports social impact startups through mentorship, connections and training opportunities.

There are more than 110 Impact Hubs globally with 24,000-plus members spanning 69 countries, making it one of the world’s largest communities for accelerating entrepreneurial solutions toward the United Nations' Sustainable Development Goals (SDGs).

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The Houston Innovation Awards program is sponsored by Houston City College Northwest, Houston Powder Coaters, FLIGHT by Yuengling, and more to be announced soon. For sponsorship opportunities, please contact sales@innovationmap.com.



Rice University launches  engineering-led brain science and health institute

brain research

Rice University has announced the creation of a new interdisciplinary center known as the Rice Brain Institute (RBI).

The new hub will aim to use engineering, natural sciences and social sciences to research the brain and reduce the burden of neurodegenerative, neurodevelopmental and mental health disorders.

“The Rice Brain Institute reflects Rice’s strength in collaboration without boundaries,” Rachel Kimbro, dean of the School of Social Sciences, said in a news release. “Our researchers are not only advancing fundamental science but they’re also ensuring that knowledge reaches society in ways that promote human flourishing.”

RBI researchers will work in thematic clusters focusing on neurodegeneration, mental health, brain injury and neurodevelopment. The clusters will work toward goals such as significantly improving key brain health outcomes, reducing mortality and mental health disorders and improving quality of life for patients living with brain injuries and neurodevelopmental disorders, according to Rice.

The institute will focus on “engineering-driven innovation,” rather than traditional neuroscience, to design tools that can measure, model and modulate brain activity based around Rice’s expertise in soft robotics, neuroimaging, data science and artificial intelligence—making it unique among peer organizations, according to Rice.

Additionally, RBI will be structured around three collaborative Rice “pillars”:

  • The Neuroengineering Initiative, launched in 2018, brings together neuroscience, engineering, and related fields experts
  • The Neuroscience Initiative, a new initiative that brings together cell biologists, neurobiologists, biochemists, chemists and physicists to explore fundamental mechanisms of the brain and nervous system
  • The Brain and Society Initiative, also a new initiative, considers brain research within the broader social and policy landscape

Rice’s Neuroengineering Initiative has already garnered more than $78 million in research funding, according to Rice, and has established major partnerships, like the Rice-Houston Methodist Center for Neural Systems Restoration.

“Rice is uniquely equipped to bridge and connect scientific understanding of the brain and behavior sciences with the technologies and policies that shape our world,” Amy Dittmar, the Howard R. Hughes Provost and executive vice president for academic affairs, added in the news release. “By uniting faculty in neuroengineering, neuroscience and psychological sciences, this interdisciplinary hub embodies the kind of bold, nimble collaboration that allows Rice to turn discovery into societal impact to save lives and enhance human flourishing.”

The formation of the RBI coincides with recent support of the Dementia Prevention Research Institute of Texas (DPRIT), which landed voter approval earlier this week and aims to make Texas the center for dementia research via brain-health tech. According to the World Economic Forum, brain disorders and mental health disorders cost the global economy an estimated $5 trillion per year and could be as high as $16 trillion by 2030.

“Few areas of research have as direct and profound an impact on human well-being as brain health,” Rice President Reginald DesRoches added in the news release. “As rates of Alzheimer’s, dementia and other neurological diseases rise in our country and around the world, universities have a responsibility to lead the discovery of solutions that preserve memory, movement and quality of life. We all know someone who has been affected by a brain-related health issue, so this research is personal to all of us.”

Texas voters OK $3 billion for new dementia research institute

state funding

Texas voters on Nov. 4 overwhelmingly approved a ballot measure that provides $3 billion in state funding over a 10-year span for the newly established Dementia Prevention and Research Institute of Texas (DPRIT).

Thanks to the passage of Proposition 14, Texas now boasts the country’s largest state-funded initiative dedicated to dementia research and prevention, according to the Alzheimer’s Association. Up to $300 million in grants will be awarded during the 10-year funding period.

“This is a transformative moment for Texas and for the fight against Alzheimer’s and all other dementia,” said Joanne Pike, president and CEO of the Alzheimer’s Association. “Texans have chosen to invest in hope, innovation, and solutions for the millions of families affected by these devastating diseases. With the passage of Proposition 14, Texas is now poised to lead the nation in dementia research and prevention.”

The association says DPRIT will drive scientific breakthroughs, attract top-notch dementia researchers to Texas, and generate thousands of jobs statewide.

An estimated 460,000 Texans are living with dementia, the association says, and more than one million caregivers support them.

DPRIT is modeled after the Cancer Prevention and Research Institute of Texas (CPRIT). Since 2008, the state agency has awarded nearly $4 billion in grants to research organizations for cancer-related academic research, prevention programs, and product development.

An analysis by the McKinsey Health Institute found that investing in brain health initiatives like DPRIT could boost Texas’ GDP by $260 billion. Much of that GDP bump could benefit the Houston area, which is home to dementia-focused organizations such as UTHealth Houston Neurosciences, Baylor College of Medicine’s Center for Alzheimer’s and Neurodegenerative Diseases, the University of Texas Medical Branch at Galveston’s Collaborative Alzheimer’s Disease and Memory Disorders Program, and the Houston Methodist Research Institute’s John M. O’Quinn Foundation Neurodegenerative Disorders Laboratory.

The Greater Houston Partnership says DPRIT holds the potential “to elevate Texas — particularly Houston — as a hub for brain health research.”

State Sen. Joan Huffman, a Houston Republican, is one of DPRIT’s champions. She sponsored legislation this year to create the institute and ask Texas voters to approve the $3 billion in funding.

“By establishing the Dementia Prevention and Research Institute of Texas, we are positioning our state to lead the charge against one of the most devastating health challenges of our time,” Huffman said in May. “With $3 billion in funding over the next decade, we will drive critical research, develop new strategies for prevention and treatment, and support our health care community.”

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