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.

------

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.

------

This article originally ran on CultureMap.

Ad Placement 300x100
Ad Placement 300x600

CultureMap Emails are Awesome

Baylor College of Medicine launches VC fund to invest in biotech startups

fresh funding

Houston’s Baylor College of Medicine just unveiled a new venture capital fund that backs early-stage biotech startups—and it’s already made its first investment.

BCM Legacy Fund I, funded by philanthropies, invested an undisclosed amount in Houston biotech startup Nemea Therapeutics. Nemea, a spinout of the Baylor College of Medicine and Germany’s Lead Discovery Center, is developing an oral drug to treat metastatic triple-negative breast cancer that no longer responds to currently available therapies.

This type of aggressive cancer spreads from the breast to other areas of the body, such as the bones, liver, lungs or brain. Roughly 38,000 to 57,000 Americans are diagnosed each year with metastatic triple-negative breast cancer. One study showed about half of patients survive past the one-year mark following diagnosis and about one-third survive two years.

“Baylor College of Medicine’s laboratories produce discoveries with the potential to change patients’ lives, and too many of them stall where academic funding ends and private investment has not yet begun,” Dr. Jakub Tolar, president, CEO and executive dean of the Baylor College of Medicine, said in a press release. “The BCM Legacy Fund fills that gap, giving our scientists a path to advance their discoveries to patients.”

The National Institutes of Health awards more than $36 billion per year for biomedical research in the U.S., Baylor said. But some biomedical discoveries “never leave the starting line because they don’t yet fit the economics of venture capital,” the college said.

“The forefront of a new model”

The BCM Legacy Fund aggregates philanthropic capital from private foundations and donor-advised funds. It then invests in startups so they can move beyond that starting line and into later-stage investment rounds. The Greater Houston Community Foundation is the fund’s philanthropic partner.

“It’s exciting to be on the forefront of a new model for philanthropic capital,” said Houston entrepreneur and investor Burton Hanson, managing partner of the fund.

“Not only do we hope to solve a real problem by advancing these therapies to the patients who need them most, but we also hope this model will inspire others in the city and beyond toward philanthropic creativity and a posture of ‘I sacrifice; we win.’”

The fund expects to invest in about 15 early-stage startups over a five-year span. Baylor declined to divulge the amount of money in the fund and the size of the investment in Nemea.

Nemea’s “world-class chemistry”

Hanson oversees the Baylor fund alongside Chicago investor Steve Lehmann, who led the University of Chicago’s Innovation Fund.

Lehmann said Nemea, the fund’s first portfolio company, “has world-class chemistry, Baylor biology, and patients with no good options. Our job is to fund the experiments that carry it to the next handoff, so that industry and later-stage investors can take it from there.”

Based at Houston’s massive Texas Medical Center, Nemea plans to start clinical trials next year in collaboration with Baylor’s Lester and Sue Smith Breast Center.

Nemea previously received $9 million from the Lead Discovery Center and a $1.6 million grant from Baylor. Last year, the startup said it was seeking $25 million to $30 million in seed and Series A funding.

Debra McCoy of Houston, a former managing director at BlackRock and former partner at Bain & Co., and Paul Thomas, co-founder and CEO of Spring-based benefits manager Luscinia Health, sit on the Baylor fund’s governing board. Dr. Paul Klotman, former president, CEO and executive dean of Baylor, is a senior strategic adviser.

How does the fund find investment targets?

The Baylor Legacy Fund relies on two tools to help unearth early-stage biotech startups:

  • High-resolution “innovation maps” of research institutions. These maps surface hidden clusters of innovation, identify rising-star researchers and tie pockets of “innovation supply” at Baylor to areas of “innovation demand” in biotech.
  • AI-enhanced due diligence. AI agents assist with due diligence of early-stage biotech startups. The fund says the platform “distills the frameworks we’ve developed over a decade of teaching and investing into a flexible … diligence environment.”

MD Anderson unveils $3.4B expansion with two new Houston cancer care facilities

major expansion

The cutting edge of cancer-fighting technology and science is getting even sharper after MD Anderson announced last week that it will open two new facilities in the Texas Medical Center within the next five years. Inspiration Tower and Prism will expand MD Anderson’s annual patient load in the TMC to 250,000 annually and will incorporate a variety of new techniques.

The $3.4 billion project will add 2 million square feet to MD Anderson's TMC footprint, bringing its total campus size to 22 million square feet by 2032. Located at the corner of Fannin Street and Holcombe Boulevard, the cancer center says the two new facilities will serve as its new "front door" to the TMC.

“Every detail of these buildings, from the technology to the treatment rooms, was designed around our patients who will receive their care in them and our employees who will work in them. The facilities will serve as a physical representation of hope for the patients and their families who will walk through the doors,” Dr. Jeffrey E. Lee, president ad interim of UT MD Anderson, said in a news release. “Inspiration Tower and Prism are the future of cancer care, and we are grateful for the longstanding support and guidance we’ve received from the UT System Board of Regents to bring these projects to life. These facilities are part of the most impactful capital expansion in UT MD Anderson’s history.”

Prism is especially exciting as it will represent fully half of the linear accelerator treatment in the TMC. Linear accelerator is a radiation treatment that uses magnetically charged fields to deliver targeted external radiation therapy, like shooting cancer with a rail gun. The treatment is safer and has fewer side effects than older radiation treatments.

In addition, Prism will contain 12 MRI machines, four CT scanners, two PET-CT units, 18 radiation vaults and seven radiation simulators. Patient comfort has also been put at a premium with multiple gardens and roof overlooks.

“Every patient we treat deserves an environment that reflects the excellence of the care they receive at UT MD Anderson,” Chris McKee, executive vice president and chief strategy officer at UT MD Anderson, added in the release. “Our new facilities will be innovative, agile, adaptable and beautiful, and they will allow us to care for more patients, more effectively – in an environment that enhances healing and well-being. We are building for our future and for every patient who will be counting on us.”

Prism is slated to open in 2030.

Inspiration Tower will have 25 floors of surgical, diagnostic, and treatment services. At 1.4 million square feet, it’s currently expected to be the largest cancer-specific treatment facility in the United States. The tower will be divided into units for specific types of cancer, making it easy to integrate the advancing research being done all over Houston.

Like Prism, Inspiration Tower is specifically designed to offer comfort and reassurance, with more garden space, terraces, and beautiful scenery to ease patient distress. It is expected to open in 2032.

Tesla will pull the plug on Cybertruck production at Texas factory in 2027

Tesla Talk

Tesla’s Cybertruck, the hulking, stainless-steel pickup that inspired devotion and derision with its science-fiction looks, will cease production next year.

CEO Elon Musk announced the model’s demise Friday, November 6, with a curt post on X, his social media site, simply noting production of the vehicle “will be winding down” around the middle of 2027 at its facility outside Austin, Texas. Musk said the move was to allow increased production of its Cybercab robotaxi.

For the Cybertruck, a pet project of Musk who insisted it was Tesla’s best product, it marks an unceremonious end to one of the auto industry’s most ballyhooed debuts.

“Few vehicles in history have generated as much attention,” said Armen Hareyan, whose Torque News site covers autos. “The Cybertruck became a cultural symbol – loved, mocked and impossible to ignore.”

The Cybertruck rolled onto the scene in a dramatic unveiling in 2019, when a Tesla designer hurled a metal ball at the vehicle to demonstrate its supposedly unbreakable glass, only to see it shatter. He repeated the stunt on another window of the truck only to shatter that one, too.

Even as some critics scoffed, Musk was steadfast.

“I just wanted to make a futuristic battle tank — something that looks like it could come out of ‘Blade Runner’ or ‘Aliens’ or something like that but was also highly functional,” he told Automotive News. He called it “a better sports car than a Porsche 911” and “a better truck than an F-150.”

It struck some as the perfect vehicular reflection of the brash, convention-busting Musk.

“A really controversial vehicle unveiled by a controversial individual into a market where none of the electric trucks have been able to really capture demand,” said Spencer Penn, a former Tesla executive who left the company before the Cybertruck’s launch and now heads software developer LightSource.

Penn remembered watching the unveiling and feeling initially revolted by the sight of the Cybertruck, calling its appearance “madness.” But the more he looked at it, the more his opinion changed. He signed up for a pre-sale reservation, though ended up not getting a Cybertruck when Musk’s promises of a price tag under $40,000 went unmet and the first trucks sold for double or more. Penn called the Cybertruck part of Tesla’s adventurous spirit that drives innovation.

“Some of these bets work and some of these bets don’t,” he said.

While the decision to end Cybertruck production may be driven by sales realities, it's also a reflection of Tesla’s shift to autonomous vehicles, on which Musk is betting the company’s future.

Musk once forecast he’d make 250,000 Cybertrucks a year. Kelley Blue Book estimated Tesla sold just 20,237 of the vehicles last year, down about half from the year prior. Sales through the end of September this year were down another 28%, according to Kelley Blue Book.

If the imposing, sharp-angled, dystopian appearance of the Cybertruck weren’t enough to turn many potential buyers away, Musk did so himself by allying with a panoply of right-wing figures, most notably U.S. President Donald Trump. He alienated some customers as his image morphed from eccentric innovator to polarizing force trading his billions for political influence.

Once-passionate Tesla drivers rushed to sell off their cars, or slapped stickers on the bumper declaring, “I bought this before Elon went crazy.” Organizers staged demonstrations outside Tesla showrooms and urged investors to dump shares of the company’s stock. Anger spilled into violence, with Molotov cocktails hurled at Tesla vehicles, charging stations set ablaze, and dealerships covered in graffiti.

Lovers of the Cybertruck became targets, too, subjected to shouts of “Nazi!” and extended middle fingers.

Ross Blankenship is one of them. When he first laid eyes on the Cybertruck, he felt transported to a world from his childhood, when he would play “Halo,” the sci-fi video game. He had to have it.

“I had that sort of child in me wanting to be part of something cool that would change the future of automotive,” Blankenship said in a call from his Cybertruck as he drove through Sunnyside, Colorado. Even as Blankenship found he agreed with Musk on politics, he hated seeing a vehicle he loved turned into a political symbol. “I never bought it for any other reason than the fascination with the future technology of trucks … so that was a little heartbreaking.”

He would buy another Cybertruck again in a heartbeat, calling its end “a sad moment.”