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'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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Rice launches 'brain economy' initiative at World Economic Forum

brain health

Rice University has launched an initiative that will position “brain capital” as a key asset in the 21st century.

Rice rolled out the Global Brain Economy Initiative on Jan. 21 at the World Economic Forum in Davos, Switzerland.

“This initiative positions brain capital, or brain health and brain skills, at the forefront of global economic development, particularly in the age of artificial intelligence,” the university said in a news release.

The Rice-based initiative, whose partners are the University of Texas Medical Branch in Galveston and the Davos Alzheimer’s Collaborative, aligns with a recent World Economic Forum and McKinsey Health Institute report titled “The Human Advantage: Stronger Brains in the Age of AI,” co-authored by Rice researcher Harris Eyre. Eyre is leading the initiative.

“With an aging population and the rapid transformation of work and society driven by AI, the urgency has never been greater to focus on brain health and build adaptable human skills—both to support people and communities and to ensure long-term economic stability,” says Amy Dittmar, a Rice provost and executive vice president for academic affairs.

This initiative works closely with the recently launched Rice Brain Institute.

In its first year, the initiative will establish a global brain research agenda, piloting brain economy strategies in certain regions, and introducing a framework to guide financial backers and leaders. It will also advocate for public policies tied to the brain economy.

The report from the McKinsey Health Institute and World Economic Forum estimates that advancements in brain health could generate $6.2 trillion in economic gains by 2050.

“Stronger brains build stronger societies,” Eyre says. “When we invest in brain health and brain skills, we contribute to long-term growth, resilience, and shared prosperity.”

Rice Alliance and the Ion leader Brad Burke to retire this summer

lasting legacy

Brad Burke—a Rice University associate vice president who leads the Ion District’s Rice Alliance for Technology and Entrepreneurship and is a prominent figure in Houston’s startup community—is retiring this summer after a 25-year career at the university.

Burke will remain at the Rice Alliance as an adviser until his retirement on June 30.

“Brad’s impact on Rice extends far beyond any single program or initiative. He grew the Rice Alliance from a promising campus initiative into one of the most respected university-based entrepreneurship platforms,” Rice President Reginald DesRoches said in a news release.

During Burke’s tenure, the Rice Business School went from unranked in entrepreneurship to The Princeton Review’s No. 1 graduate entrepreneurship program for the past seven years and a top 20 entrepreneurship program in U.S. News & World Report’s rankings for the past 14 years.

“Brad didn’t just build programs — he built an ecosystem, a culture, and a reputation for Rice that now resonates around the world,” said Peter Rodriguez, dean of the business school. “Through his vision and steady leadership, Rice became a place where founders are taken seriously, ideas are rigorously supported, and entrepreneurship is embedded in the fabric of the university.”

One of Burke’s notable achievements at Rice is the creation of the Rice Business Plan Competition. During his tenure, the competition has grown from nine student teams competing for $10,000 into the world’s largest intercollegiate competition for student-led startups. Today, the annual competition welcomes 42 student-led startups that vie for more than $1 million in prizes.

Away from Rice, Burke has played a key role in cultivating entrepreneurship in the energy sector: He helped establish the Energy Tech Venture Forum along with Houston Energy and Climate Startup Week.

Furthermore, Burke co-founded the Texas University Network for Innovation and Entrepreneurship in 2008 to bolster the entrepreneurship programs at every university in Texas. In 2016, the Rice Alliance assumed leadership of the Global Consortium of Entrepreneurship Centers.

In 2023, Burke received the Trailblazer Award at the 2023 Houston Innovation Awards and was recognized by the Deshpande Foundation for his contributions to innovation and entrepreneurship in higher education.

“Working with an amazing team to build the entrepreneurial ecosystem at Rice, in Houston, and beyond has been the privilege of my career,” Burke said in the release. “It has been extremely gratifying to hear entrepreneurs say our efforts changed their lives, while bringing new innovations to market. The organization is well-positioned to help drive exponential growth across startups, investors, and the entrepreneurial ecosystem.”

Starting April 15, John “JR” Reale Jr. will serve as interim associate vice president at Rice and executive director of the Rice Alliance. He is managing director of the alliance. Reale is co-founder of the Station Houston startup hub and a startup investor. He was also recently named director for startups and investor engagement at the Ion.

“The Rice Alliance has always been about helping founders gain advantages to realize their visions,” Reale said. “Under Brad’s leadership, the Rice Alliance has become a globally recognized platform that is grounded in trust and drives transformational founder outcomes. My commitment is to honor what Brad has built and led while continuing to serve our team and community, deepen relationships and deliver impact.”

Burke joined the Houston Innovators Podcast back in 2022. Listen to the full interview here.

Houston team uses CPRIT funding to develop nanodrug for cancer immunotherapy

cancer research

With a relative five-year survival rate of 50 percent, pancreatic cancer is a diagnosis nobody wants. At 60 percent, the prognosis for lung cancer isn’t much rosier. That’s because both cancers contain regulatory B cells (Bregs), which block the body’s natural immunity, making it harder to fight the enemies within.

Newly popular immunotherapies in a category known as STING agonists may stimulate natural cancer defenses. However, they can also increase Bregs while simultaneously causing significant side effects. But Wei Gao, assistant professor of pharmacology at the University of Houston College of Pharmacy, may have a solution to that conundrum.

Gao and her team have developed Nano-273, a dual-function drug, packaged in an albumin-based particle, that boosts the immune system to help it better fight pancreatic and lung cancers. Gao’s lab recently received a $900,000 grant from the Cancer Prevention and Research Institute of Texas (CPRIT) to aid in fueling her research into the nanodrug.

“Nano-273 both activates STING and blocks PI3Kγ—a pathway that drives Breg expansion, while albumin nanoparticles help deliver the drug directly to immune cells, reducing unwanted side effects,” Gao said in a press release. “This approach reduces harmful Bregs while boosting immune cells that attack cancer, leading to stronger and more targeted anti-tumor responses.”

In studies using models of both pancreatic and lung cancers, Nano-273 has shown great promise with low toxicity. Its best results thus far have involved using the drug in combination with immunotherapy or chemotherapy.

With the CPRIT funds, Gao and her team will be able to charge closer to clinical use with a series of important steps. Those include continuing to test Nano-273 alongside other drugs, including immune checkpoint inhibitors. Safety studies will follow, but with future patients in mind, Gao will also work toward improving her drug’s production, making sure that it’s safe and high-quality every time, so that it is eventually ready for trials.

Gao added: “If successful, this project could lead to a new type of immunotherapy that offers lasting tumor control and improved survival for patients with pancreatic and lung cancers, two diseases that urgently need better treatments."

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