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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UH student earns prestigious award for cancer vaccine research

up-and-comer

Cole Woody, a biology major in the College of Natural Sciences and Mathematics at the University of Houston, has been awarded a Barry Goldwater Scholarship, becoming the first sophomore in UH history to earn the prestigious prize for research in natural sciences, mathematics and engineering.

Woody was recognized for his research on developing potential cancer vaccines through chimeric RNAs. The work specifically investigates how a vaccine can more aggressively target cancers.

Woody developed the MHCole Pipeline, a bioinformatic tool that predicts peptide-HLA binding affinities with nearly 100 percent improvement in data processing efficiency. The MHCole Pipeline aims to find cancer-specific targets and develop personalized vaccines. Woody is also a junior research associate at the UH Sequencing Core and works in Dr. Steven Hsesheng Lin’s lab at MD Anderson Cancer Center.

“Cole’s work ethic and dedication are unmatched,” Preethi Gunaratne, director of the UH Sequencing Core and professor of Biology & Biochemistry at NSM, said in a news release. “He consistently worked 60 to 70 hours a week, committing himself to learning new techniques and coding the MHCole pipeline.”

Woody plans to earn his MD-PhD and has been accepted into the Harvard/MIT MD-PhD Early Access to Research Training (HEART) program. According to UH, recipients of the Goldwater Scholarship often go on to win various nationally prestigious awards.

"Cole’s ability to independently design and implement such a transformative tool at such an early stage in his career demonstrates his exceptional technical acumen and creative problem-solving skills, which should go a long way towards a promising career in immuno-oncology,” Gunaratne added in the release.

Houston founder on shaping the future of medicine through biotechnology and resilience

Guest Column

Living with chronic disease has shaped my life in profound ways. My journey began in 5th grade when I was diagnosed with Scheuermann’s disease, a degenerative disc condition that kept me sidelined for an entire year. Later, I was diagnosed with hereditary neuropathy with liability to pressure palsies (HNPP), a condition that significantly impacts nerve recovery. These experiences didn’t just challenge me physically, they reshaped my perspective on healthcare — and ultimately set me on my path to entrepreneurship. What started as personal health struggles evolved into a mission to transform patient care through innovative biotechnology.

A defining part of living with these conditions was the diagnostic process. I underwent nerve tests that involved electrical shocks to my hands and arms — without anesthesia — to measure nerve activity. The pain was intense, and each test left me thinking: There has to be a better way. Even in those difficult moments, I found myself thinking about how to improve the tools and processes used in healthcare.

HNPP, in particular, has been a frustrating condition. For most people, sleeping on an arm might cause temporary numbness that disappears in an hour. For me, that same numbness can last six months. Even more debilitating is the loss of strength and fine motor skills. Living with this reality forced me to take an active role in understanding my health and seeking solutions, a mindset that would later shape my approach to leadership.

Growing up in Houston, I was surrounded by innovation. My grandfather, a pioneering urologist, was among the first to introduce kidney dialysis in the city in the 1950s. His dedication to advancing patient care initially inspired me to pursue medicine. Though my path eventually led me to healthcare administration and eventually biotech, his influence instilled in me a lifelong commitment to medicine and making a difference.

Houston’s thriving medical and entrepreneurial ecosystems played a critical role in my journey. The city’s culture of innovation and collaboration provided opportunities to explore solutions to unmet medical needs. When I transitioned from healthcare administration to founding biotech companies, I drew on the same resilience I had developed while managing my own health challenges.

My experience with chronic disease also shaped my leadership philosophy. Rather than accepting diagnoses passively, I took a proactive approach questioning assumptions, collaborating with experts, and seeking new solutions. These same principles now guide decision-making at FibroBiologics, where we are committed to developing groundbreaking therapies that go beyond symptom management to address the root causes of disease.

The resilience I built through my health struggles has been invaluable in navigating business challenges. While my early career in healthcare administration provided industry insights, launching and leading companies required the same determination I had relied on in my personal health journey.

I believe the future of healthcare lies in curative treatments, not just symptom management. Fibroblast cells hold the promise of engaging the body’s own healing processes — the most powerful cure for chronic diseases. Cell therapy represents both a scientific breakthrough and a significant business opportunity, one that has the potential to improve patient outcomes while reducing long-term healthcare costs.

Innovation in medicine isn’t just about technology; it’s about reimagining what’s possible. The future of healthcare is being written today. At FibroBiologics, our mission is driven by more than just financial success. We are focused on making a meaningful impact on patients’ lives, and this purpose-driven approach helps attract talent, engage stakeholders, and differentiate in the marketplace. Aligning business goals with patient needs isn’t just the right thing to do, it’s a powerful model for sustainable growth and lasting innovation in biotech.

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Pete O’Heeron is the CEO and founder of FibroBiologics, a Houston-based regenerative medicine company.


Houston researchers make headway on affordable, sustainable sodium-ion battery

Energy Solutions

A new study by researchers from Rice University’s Department of Materials Science and NanoEngineering, Baylor University and the Indian Institute of Science Education and Research Thiruvananthapuram has introduced a solution that could help develop more affordable and sustainable sodium-ion batteries.

The findings were recently published in the journal Advanced Functional Materials.

The team worked with tiny cone- and disc-shaped carbon materials from oil and gas industry byproducts with a pure graphitic structure. The forms allow for more efficient energy storage with larger sodium and potassium ions, which is a challenge for anodes in battery research. Sodium and potassium are more widely available and cheaper than lithium.

“For years, we’ve known that sodium and potassium are attractive alternatives to lithium,” Pulickel Ajayan, the Benjamin M. and Mary Greenwood Anderson Professor of Engineering at Rice, said in a news release. “But the challenge has always been finding carbon-based anode materials that can store these larger ions efficiently.”

Lithium-ion batteries traditionally rely on graphite as an anode material. However, traditional graphite structures cannot efficiently store sodium or potassium energy, since the atoms are too big and interactions become too complex to slide in and out of graphite’s layers. The cone and disc structures “offer curvature and spacing that welcome sodium and potassium ions without the need for chemical doping (the process of intentionally adding small amounts of specific atoms or molecules to change its properties) or other artificial modifications,” according to the study.

“This is one of the first clear demonstrations of sodium-ion intercalation in pure graphitic materials with such stability,” Atin Pramanik, first author of the study and a postdoctoral associate in Ajayan’s lab, said in the release. “It challenges the belief that pure graphite can’t work with sodium.”

In lab tests, the carbon cones and discs stored about 230 milliamp-hours of charge per gram (mAh/g) by using sodium ions. They still held 151 mAh/g even after 2,000 fast charging cycles. They also worked with potassium-ion batteries.

“We believe this discovery opens up a new design space for battery anodes,” Ajayan added in the release. “Instead of changing the chemistry, we’re changing the shape, and that’s proving to be just as interesting.”

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This story originally appeared on EnergyCapitalHTX.com.

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