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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NASA unveils Artemis III astronauts at Johnson Space Center in Houston

To the moon

NASA on Tuesday, June 9, revealed the crew for its Artemis III mission, the next step in the space agency's plan to eventually land astronauts on the moon.

The announcement came two months after Artemis II's record-breaking trip around the moon that surpassed the distance record of Apollo 13.

NASA's Randy Bresnik, Frank Rubio, Andre Douglas and the European Space Agency's Luca Parmitano won't fly to the moon or land on the surface. Instead, they’ll orbit Earth while practicing docking their Orion capsule with two lunar landers.

“To the Artemis III crew, we wish you Godspeed on the journey ahead,” said NASA administrator Jared Isaacman.

Elon Musk’s SpaceX and Jeff Bezos’ Blue Origin are racing to deliver the lunar landers. The two-week demo is targeted for 2027. Blue Origin suffered a recent setback when its massive rocket exploded during an engine-firing test on the launch pad in Florida, shaking nearby homes and illuminating the sky with an orange fireball.

NASA's Jeremy Parsons said the setback is a learning opportunity and that the space agency is confident Blue Origin's rocket will be ready in time.

NASA's Artemis program aims to return astronauts to the moon's surface for the first time since the 1970s. A recent revamp of the program announced by Isaacman aims to fast-track it similarly to the Apollo era, adding the upcoming spaceflight around Earth before eyeing a lunar landing in 2028.

“We are certainly humbled as a crew to be able to be your crew that executes this Artemis III mission in space,” said Bresnik, Artemis III commander.

Added Douglas, mission specialist: “My brain — it is going a mile a minute right now. But my heart, it is so warm. It is so full."

In May, NASA awarded hundreds of millions of dollars in contracts to four companies, including Blue Origin, to build landers, rovers and drones for a future moon base. Isaacman said the goal of the moon base is to lay the foundation for a Mars expedition.

Meta to bring $115 million AI data center training initiative to Houston

ai workforce

Meta and Associated Builders and Contractors have entered into a partnership to invest $115 million in training programs for the construction of AI data centers, with a portion of the project launching in Houston.

The companies announced June 8 that they would open America’s Workforce Academies at ABC chapter training centers in Houston; Indianapolis; Baton Rouge, Louisiana; and Columbus, Ohio.

The academies will offer career readiness and safety training, plus five weeks of hands-on education. Participants who complete the program will be granted a job offer from contractors working on Meta projects.

“The AI revolution is bringing change but also historic opportunities,” Dina Powell McCormick, Meta president and vice-chairman, said in a news release. “Skilled workers electrified rural America one pole at a time. They manned the factories that built the arsenal that won World War II. Now a new generation will pour the foundations and lay the fiber that secures American strength in this new age.”

Overall, the Meta and ABC aim for the academies to build a more sustainable pipeline of skilled construction workers and ensure safety and job readiness for the surging number of data center projects underway.

“This new program is an innovative talent solution that is a critical part of addressing the construction industry’s ongoing workforce shortage and creates an accelerated, new-entrant strategy for job seekers ... The sustained demand for data center construction technicians means the industry needs an all-of-the-above approach to address this shortage and grow the construction talent pool,” Michael Bellaman, ABC president and CEO, added in the release.

In Texas, Meta, the parent company of Facebook and Instagram, has launched or broken ground on data centers in El Paso, Fort Worth and Temple. The company announced in March that it planned to grow its El Paso Data center by 1 gigawatt, representing more than a $10 billion investment.

Apart from Meta, Texas has attracted data center development to power other giants like Google and Amazon in recent years. In turn, Texas has been predicted to become the biggest data center market. Commercial real estate services provider JLL reported this spring that the state could topple Northern Virginia as the world’s largest data-center market by 2030. Similarly, CBRE predicted that Houston's data center capacity could double by 2028. Read more here.

New Houston biotech co. lands $30M for pulmonary fibrosis drug

drug money

Most of us can claim a scar or two on our bodies. But when scarring develops inside the body, it’s known as a fibrotic disorder. A freshly launched Houston company, Oorja Bio Inc., is working on a treatment that can help to repair cells and reduce the damage wrought by the growth of fibrotic tissue in patients.

Late last month, Oorja Bio hit the scene with a pair of big announcements. Not only has the company raised a $30 million Series A thanks to founding investor California-based Westlake BioPartners, but it has also already paved the way for a Phase 2 study to take place this year.

Oorja Bio received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA), allowing the company to test its treatment in patients with idiopathic pulmonary fibrosis (IPF), a scarring of the lung tissue. IPF affects more than 150,000 adults in the United States and can result in a range of symptoms from shortness of breath to organ failure and death as it progresses.

Oorja Bio’s lead drug candidate, ORJ-001, was shown in a Phase 1 in-human trial to demonstrate “therapeutically relevant exposure and favorable tolerability” in 64 healthy adult volunteers in whom it was administered daily or weekly, according to a news release. Pre-clinical studies of ORJ-001 showed durable target tissue engagement and biomarker activity in bleomycin-induced lung fibrosis.

Administered subcutaneously, ORJ-001 is intended to improve and even restore function in cells that can reduce the signaling that causes IPF. It stops advancement of IPF and also allows for tissue repair. Currently available treatments for the disease can slow the development of IPF down, but do not address the declining lung function that’s inherent in its progression.

“The clinical and preclinical results from our studies to date give us confidence that ORJ-001 represents a novel treatment approach with the potential to repair and reverse fibrosis and modify disease progression in IPF,” Dr. Janethe Pena, CMO of Oorja Bio, said in the release.

“Our team is energized to deliver on our goal of redefining the future of fibrotic diseases, beginning with ORJ-001,” CEO and founder Sujay Kango added. “As we advance ORJ-001 in the clinic, we are embracing the paradigm shift in our biological understanding of IPF pathology that aligns with the central role of the alveolar epithelium. ORJ-001 was designed with this biology in mind and may provide, for the first time, a therapeutic intervention that repairs and reverses fibrosis and promotes disease modification.”

Most patients live only three to five years following their IPF diagnosis. Soon, ORJ-001 and Oorja Bio could give them a fighting chance.