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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Houston medtech startup clears FDA approval for new surgical tool

precision surgery

Houston-based Prana Surgical will soon bring a new electrosurgical tool to operating rooms around the country. The Prana System officially cleared U.S. Food and Drug Administration (FDA) approval earlier this month.

"Receiving FDA clearance for the Prana System represents a defining milestone for our company," Joanna Nathan, CEO and co-founder of Prana Surgical, said in a news release. "Surgeons today are increasingly focused on achieving precise outcomes while minimizing disruption to healthy tissue. The Prana System was designed to support that shift by integrating targeting and excision into a single, streamlined tool."

Prana Surgical began as Prana Thoracic in 2022. Back then, the company primarily focused on developing screening tools for lung cancer diagnosis. It raised $6 million in series A funding rounds in 2023 and 2024 before transitioning to broader surgical needs in 2025.

The Prana System is a minimally invasive, image-guided, single-use tissue extraction tool designed to retrieve samples without damaging healthy tissue. The tool is still designed with the respiratory system in mind, helping Prana in the fight against lung cancer and other thoracic diseases.

Reducing the impact of tissue extraction via electrosurgery and enhanced image scanning can significantly reduce complications. The Prana System combines localization and tissue-cutting capabilities in one, which keeps surgeons from having to swap out components during a procedure, making for a smoother process. It can core, cut and feel blood vessels on the way toward the intended target, giving surgeons greater control over tissue preservation.

"Electrosurgery is foundational to modern surgery, but there is still opportunity to improve how energy-based tools are applied in minimally invasive settings," Nathan added. "Our goal is to introduce a new class of image-guided surgical tools that enable more precise intervention across a range of procedures."

The company projects sales of $7.5 billion from the Prana System in the United States, estimating that 2.5 million surgical modules will be able to use the new tool. While starting out focused on biopsies, the company plans to evolve the system into other procedures, such as ablation, in the future. It is also planning for a controlled U.S. clinical rollout as it moves toward commercialization

Texas still ranks as No. 1 in U.S. for inbound moves, but growth dips

by the numbers

Texas continues to be the country’s No. 1 magnet for newcomers from other states, giving a boost to the state’s economy. However, Texas’ appeal weakened in 2024 compared with the previous year, due in large part to spiking home prices.

An analysis of U.S. Census Bureau data by self-storage platform StorageCafe shows Texas saw net interstate migration of 76,000 people in 2024. Texas’ net interstate migration dropped nearly 50 percent from 2023, according to the analysis. Net migration refers to the number of incoming residents minus the number of outgoing residents.

California remained the top source of newcomers for Texas, sending nearly 77,000 residents to the Lone Star State in 2024, the analysis says. Florida ranked second, followed by New York, Colorado and Illinois.

“These trends reveal Texas’ continued pull from both high-cost coastal markets and other large Sun Belt states, resulting in a mix of affordability-driven and job-driven relocation,” StorageCafe says.

Putting a damper on the influx of new residents: a roughly 124 percent surge in Texas home prices over the past decade, according to StorageCafe.

“While the state remains significantly more affordable than California, its top feeder state, the once-wide pricing gap has narrowed,” says StorageCafe. “For many movers, Texas is still a relative bargain, but no longer an undisputed one.”

Nonetheless, Texas keeps attracting young, highly educated people, which bodes well for the state’s long-term economic outlook, StorageCafe says. More than half of new arrivals to Texas in 2024 held at least a bachelor’s degree, and the age of newcomers averaged 32.

Where are most of these young, highly educated newcomers settling?

Lloyd Potter, former Texas state demographer, tells StorageCafe that population growth in Texas is happening most rapidly in suburban “ring counties” at the expense of slowing growth in urban cores. Ring counties are on the outskirts of major metro areas.

“Many people are moving from urban cores to suburban rings seeking lower costs, newer housing, better schools, and more space,” Potter says. “Typically, a move to a suburban county will be within commuting or hybrid‑commuting distance of major metro economies.”

Artemis II makes historic call to space station with help from Houston Mission Control

History in the making

Still aglow from their triumphant lunar flyby, the Artemis II astronauts made more history Tuesday, April 7: calling their friends aboard the International Space Station hundreds of thousands of miles away as they headed home from the moon.

It was the first moonship-to-spaceship radio linkup ever. NASA's Apollo crews had no off-the-planet company back in the 1960s and 1970s, the last time humanity set sail for deep space.

"We have been waiting for this like you can’t imagine,” Artemis II commander Reid Wiseman called out.

For Christina Koch on Artemis II and Jessica Meir aboard the space station, it marked a joyous space reunion despite being 230,000 miles (370,000 kilometers) apart. The two teamed up for the world's first all-female spacewalk in 2019 outside the orbiting lab.

Koch told her “astro-sister” that she'd hoped to meet up with her again in space “but I never thought it would be like this — it's amazing.”

“I'm so happy that we are back in space together,” Meir replied, “even if we are a few miles apart.”

Houston's Mission Control arranged the cosmic chitchat between the four lunar travelers and the space station's three NASA and one French residents.

Koch described being awe-struck by not just the beauty of Earth, “but how much blackness there was around it.”

“It just made it even more special. It truly emphasized how alike we are, how the same thing keeps every single person on planet Earth alive,” she told the space station crew. “The specialness and preciousness of that really is emphasized” when viewing the home planet from the moon.

By late Tuesday afternoon, the Artemis II astronauts had beamed back more than 50 gigabytes' worth of pictures and other data from the previous day's lunar rendezvous, which set a new distance record for humanity. The highlight: an Earthset photo reminiscent of Apollo 8's Earthrise shot from 1968.

"While they are inspirational and, I think, allow all of us to really feel a little bit of what they were feeling, there's also a lot of science hidden inside of those images," said Mission Control's lead lunar scientist Kelsey Young. “The conversations and the science lessons learned are just beginning."

During a debriefing with Young, the astronauts recounted how they spotted a cascade of pinpricks of light on the lunar surface from impacting cosmic debris. The flashes lasted mere milliseconds and coincided by chance with Monday evening's total solar eclipse.

Young said it was too soon to know whether the crew witnessed an actual meteor shower or more random, run-of-the-mill micrometeoroid hits. Either way, there were “audible screams of delight” in the science operations center, she said.

Koch described being awe-struck by not just the beauty of Earth, “but how much blackness there was around it.”

“It just made it even more special. It truly emphasized how alike we are, how the same thing keeps every single person on planet Earth alive,” she told the space station crew. “The specialness and preciousness of that really is emphasized” when viewing the home planet from the moon.

The first lunar explorers since Apollo 17 in 1972, Wiseman and his crew are aiming for a splashdown off the San Diego coast on Friday to wrap up the nearly 10-day test flight. The recovery ship USS John P. Murtha left port Tuesday for the target zone.

It sets the stage for next year's Artemis III, a lunar lander docking demo in orbit around Earth. Artemis IV will follow in 2028 with two astronauts attempting to land near the lunar south pole.

As for the Orion capsule’s pesky potty, Mission Control assured the astronauts that no maintenance was required Tuesday. The toilet has been on-and-off limits to the crew ever since last week’s launch, prompting them to rely on a backup bag-and-funnel system for urinating.

NASA Administrator Jared Isaacman told the crew following the lunar flyby Monday night: “We definitely have to fix some of the plumbing” ahead of the next Artemis mission. Engineers suspect a clogged filter in the overboard flushing system.

Aside from the toilet and other relatively minor matters, the mission has gone well, Isaacman noted at a news conference Tuesday, “but I'll breathe easier when we get through reentry and everybody's under chutes and in the water.”

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