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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2 Houston space tech cos. celebrate major tech milestones

big wins

Two Houston aerospace companies — Intuitive Machines and Venus Aerospace — have reached testing milestones for equipment they’re developing.

Intuitive Machines recently completed the first round of “human in the loop” testing for its Moon RACER (Reusable Autonomous Crewed Exploration Rover) lunar terrain vehicle. The company conducted the test at NASA’s Johnson Space Center.

RACER is one of three lunar terrain vehicles being considered by NASA for the space agency’s Artemis initiative, which will send astronauts to the moon.

NASA says human-in-the-loop testing can reveal design flaws and technical problems, and can lead to cost-efficient improvements. In addition, it can elevate the design process from 2D to 3D modeling.

Intuitive Machines says the testing “proved invaluable.” NASA astronauts served as test subjects who provided feedback about the Moon RACER’s functionality.

The Moon RACER, featuring a rechargeable electric battery and a robotic arm, will be able to accommodate two astronauts and more than 880 pounds of cargo. It’s being designed to pull a trailer loaded with more than 1,760 pounds of cargo.

Another Houston company, Venus Aerospace, recently achieved ignition of its VDR2 rocket engine. The engine, being developed in tandem with Ohio-based Velontra — which aims to produce hypersonic planes — combines the functions of a rotating detonation rocket engine with those of a ramjet.

A rotating detonation rocket engine, which isn’t equipped with moving parts, rapidly burns fuel via a supersonic detonation wave, according to the Air Force Research Laboratory. In turn, the engine delivers high performance in a small volume, the lab says. This savings in volume can offer range, speed, and affordability benefits compared with ramjets, rockets, and gas turbines.

A ramjet is a type of “air breathing” jet engine that does not include a rotary engine, according to the SKYbrary electronic database. Instead, it uses the forward motion of the engine to compress incoming air.

A ramjet can’t function at zero airspeed, so it can’t power an aircraft during all phases of flight, according to SKYbrary. Therefore, it must be paired with another kind of propulsion, such as a rotating detonation rocket engine, to enable acceleration at a speed where the ramjet can produce thrust.

“With this successful test and ignition, Venus Aerospace has demonstrated the exceptional ability to start a [ramjet] at takeoff speed, which is revolutionary,” the company says.

Venus Aerospace plans further testing of its engine in 2025.

Venus Aerospace, recently achieved ignition of its VDR2 rocket engine. Photo courtesy of Venus Aerospace

METRO rolls out electric shuttles for downtown Houston commuters

on a roll

The innovative METRO microtransit program will be expanding to the downtown area, the Metropolitan Transit Authority of Harris County announced on Monday.

“Microtransit is a proven solution to get more people where they need to go safely and efficiently,” Houston Mayor John Whitmire said in a statement. “Connected communities are safer communities, and bringing microtransit to Houston builds on my promise for smart, fiscally-sound infrastructure growth.”

The program started in June 2023 when the city’s nonprofit Evolve Houston partnered with the for-profit Ryde company to offer free shuttle service to residents of Second and Third Ward. The shuttles are all-electric and take riders to bus stops, medical buildings, and grocery stores. Essentially, it works as a traditional ride-share service but focuses on multiple passengers in areas where bus access may involve hazards or other obstacles. Riders access the system through the Ride Circuit app.

So far, the microtransit system has made a positive impact in the wards according to METRO. This has led to the current expansion into the downtown area. The system is not designed to replace the standard bus service, but to help riders navigate to it through areas where bus service is more difficult.

“Integrating microtransit into METRO’s public transit system demonstrates a commitment to finding innovative solutions that meet our customers where they are,” said METRO Board Chair Elizabeth Gonzalez Brock. “This on-demand service provides a flexible, easier way to reach METRO buses and rail lines and will grow ridership by solving the first- and last-mile challenges that have hindered people’s ability to choose METRO.”

The City of Houston approved a renewal of the microtransit program in July, authorizing Evolve Houston to spend $1.3 million on it. Some, like council member Letitia Plummer, have questioned whether microtransit is really the future for METRO as the service cuts lines such as the University Corridor.

However, the microtransit system serves clear and longstanding needs in Houston. Getting to and from bus stops in the city with its long blocks, spread-out communities, and fickle pedestrian ways can be difficult, especially for poor or disabled riders. While the bus and rail work fine for longer distances, shorter ones can be underserved.

Even in places like downtown where stops are plentiful, movement between them can still involve walks of a mile or more, and may not serve for short trips.

“Our microtransit service is a game-changer for connecting people, and we are thrilled to launch it in downtown Houston,” said Evolve executive director Casey Brown. “The all-electric, on-demand service complements METRO’s existing fixed-route systems while offering a new solution for short trips. This launch marks an important milestone for our service, and we look forward to introducing additional zones in the new year — improving access to public transit and local destinations.”

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This article originally ran on CultureMap.

Cart.com's M&A move, energy innovators recognized, and more top articles from the week

trending news

Editor's note:Let's roundup the most-read Houston innovation news from the week. Trending Houston tech and startup articles from InnovationMap and its daily newsletter included a new health tech grant for Houston researchers, Cart.com's latest acquisition, and more.

Houston med school lands $3.5M grant to rollout genetic telehealth platform for underserved newborns

Baylor College of Medicine received $3.5 million to expand its telehealth platform to improve genomic diagnostics and care for critically ill newborns in underserved neonatal intensive care units in West and South Texas. Photo by Tim Bish on Unsplash

Baylor College of Medicine received $3.5 million to help hospitals in Texas better care for and diagnose some of the state's most vulnerable patients.

The funds come from the National Human Genome Research Institute for the Making Genomics Accessible to Newborns in Texas, or MAGNET, program. They'll be used to adapt BCM's Consultagene telehealth platform to be used in underserved neonatal intensive care units in West and South Texas, according to a statement.

Families in this region of the state currently can travel up to 300 miles to reach the nearest in-state geneticist, according to MAGNET. The program aims to help close that gap through BCM's established remote consultation service. Investigators also plan to create educational videos in English and Spanish to educate providers and patient caregivers on genetic diagnoses.

“Only 20 years ago, less than 3 percent of genetic conditions in newborns could be molecularly diagnosed,” Dr. Brendan Lee, co-principal investigator and professor and chair of the Department of Molecular and Human Genetics and Robert and Janice McNair Endowed Chair in Molecular and Human Genetics at BCM, says in a statement. Continue reading.

Houston e-commerce platform expands logistics network with acquisition of fulfillment operations arm

Cart.com has acquired OceanX, adding two new facilities and expanding its logistics network to enhance efficiency and support high-volume beauty, wellness, and lifestyle brands. Photo courtesy of Cart.com

A Houston e-commerce unicorn has made its latest strategic acquisition.

Cart.com, which operates a multichannel commerce platform, announced that it has acquired Guthy-Renker's wholly-owned fulfillment operations arm OceanX. The terms of the deal were not disclosed. Around 200 OceanX employees will be assumed onto the Cart.com team, and the fast-growing company will add two new facilities totaling over 600,000 square feet to its network, expanding to include a West Coast distribution hub in Southern California and its third facility near Columbus, Ohio.

"Acquiring OceanX is part of Cart.com’s strategy to continue to scale our platform and capabilities across industries, leveraging our proprietary technology to improve efficiency and deliver superior results to our clients and their customers,” Omair Tariq, Cart.com founder and CEO, says in a news release. “By deploying our Constellation OMS and WMS software and seasoned operations team across these two new facilities, we will improve order visibility, labor efficiency, shipping costs and customer satisfaction for the benefit of our new clients.” Continue reading.

3 clean energy innovators make Forbes list of top young energy professionals

Three young professionals have made the cut for this year's Forbes Under 30 list in the Energy and Green Tech list for 2025. Photos via Forbes

A handful of Houstonians have been named to the Forbes 30 Under 30 Energy and Green Tech list for 2025.

Kip Daujotas is an investment associate at Aramco Ventures, a $7.5 billion venture capital arm of the world's largest energy company. Houston is the Americas headquarters for Saudi Aramco. Since its inception in 2012, Aramco Ventures has invested in more than 100 tech startups. Daujotas joined the team over two years ago after studying for an MBA at Yale University. He led Aramco’s first direct air capture (DAC) investment — in Los Alamos, New Mexico-based Spiritus.

Also representing the corporate side of the industry, Wenting Gao immigrated from Beijing to obtain an economics degree from Harvard University, then got a job at consulting giant McKinsey, where she recently became the firm’s youngest partner. Gao works on bringing sustainability strategies to energy and materials companies as well as investors. Her areas of expertise include battery materials, waste, biofuels, and low-carbon products.

Last but not least, Houston entrepreneur Rawand Rasheed is co-founder and CEO of Houston-based Helix Earth. He co-founded the startup after earning a doctoral degree from Rice University and co-inventing Helix’s core technology while at NASA, first as a graduate research fellow and then as an engineer. The core technology, a space capsule air filtration system, has been applied to retrofitting HVAC systems for commercial buildings. Continue reading.

Rice University, Houston Methodist launch new institute to revolutionize health care through AI, innovation

Rice University and Houston Methodist have partnered to create the Digital Health Institute, combining advanced technology, artificial intelligence, and interdisciplinary expertise to transform health care. Photos courtesy

Rice University and Houston Methodist have established through a multi-year joint effort the Digital Health Institute, which aims to transform healthcare through advanced technology and the collaborative expertises of the university and hospital.

Rice’s leadership in engineering, digital health and artificial intelligence will combine with Houston Methodist’s academic medicine and research infrastructure.

“This partnership embodies Rice’s bold vision to lead at the forefront of innovation in health and responsible AI,” Rice President Reginald DesRoches says in a news release. “By combining our strengths with Houston Methodist, we are creating a transformative platform to address critical challenges in healthcare with solutions that are ethical, accessible and impactful. This initiative exemplifies our commitment to driving interdisciplinary collaboration and advancing global health for the benefit of humanity.” Continue reading.

2 Houston professors named as fellows for prestigious group of inventors

Omid Veiseh from Rice University and Edward Ratner from the University of Houston have been named 2024 National Academy of Inventors fellows for their innovative contributions. Courtesy photos

The highest professional distinction awarded to academic inventors, the National Academy of Inventors, have elected two fellows from Rice University and the University of Houston for its 2024 class.

Edward Ratner, computer information systems lecturer in the Department of Information Science Technology at the University of Houston’s Cullen College of Engineering, and Omid Veiseh, bioengineer at Rice University and director of the Biotech Launch Pad, were two of the 170 honorees representing 39 states and 12 countries.

The 2024 class will be honored and presented their medals on June 26 in Atlanta, Georgia by a senior official of the U.S. Patent and Trademark Office. Continue reading.

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