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 company awarded $2.5B NASA contract to support astronaut health and space missions

space health

Houston-based technology and energy solution company KBR has been awarded a $2.5 billion NASA contract to support astronaut health and reduce risks during spaceflight missions.

Under the terms of the Human Health and Performance Contract 2, KBR will provide support services for several programs, including the Human Research Program, International Space Station Program, Commercial Crew Program, Artemis campaign and others. This will include ensuring crew health, safety, and performance; occupational health services and risk mitigation research for future flights.

“This contract reinforces KBR’s leadership in human spaceflight operations and highlights our expertise in supporting NASA’s vision for space exploration,” Mark Kavanaugh, KBR president of defense, intel and space, said in a news release.

The five-year contract will begin Nov. 1 with possible extension option periods that could last through 2035. The total estimated value of the base period plus the optional periods is $3.6 billion, and the majority of the work will be done at NASA’s Johnson Space Center.

“We’re proud to support NASA’s critical work on long-duration space travel, including the Artemis missions, while contributing to solutions that will help humans live and thrive beyond Earth,” Kavanaugh adde in the news release.

Recently, KBR and Axiom Space completed three successful crewed underwater tests of the Axiom Extravehicular Mobility Unit (AxEMU) at NASA's Neutral Buoyancy Laboratory (NBL) at Johnson Space Center. The tests were part of an effort to help both companies work to support NASA's return to the Moon, according to a release.

KBR also landed at No. 3 in a list of Texas businesses on Time and Statista’s new ranking of the country’s best midsize companies.

UH receives $1M grant to advance research on rare pediatric disorder

peds research

The University of Houston has received a two-year, $1.1 million gift from the Cynthia and George Mitchell Foundation to advance research on a rare genetic disorder that can lead to both deafness and blindness in children, known as Usher Syndrome.

The current grant will support the research of UH biomedical engineering professors Muna Naash and Muayyad Al-Ubaidi, who work in the Laboratory for Retinal Molecular and Cellular Biology and Gene Therapy in the Cullen College of Engineering. The professors have published their findings in the journal Nature Communications.

Naash and Al-Ubaidi’s research focuses on mutations in the USH2A gene, which is crucial to the development and maintenance of the inner ear and retina. The work was inspired by a chance meeting that changed Naash’s life.

“Our work began more than two decades ago when I met a young boy who had lost his both his vision and hearing, and it made me realize just how precious those two senses are, and it truly touched my heart,” Naash said in a news release from UH. “Thanks to the generosity of the Cynthia and George Mitchell Foundation, we can now take the next critical steps in our research and bring hope to families affected by this challenging condition.”

The grant from the foundation comes in addition to a previous $1.6 million award from the National Eye Institute in 2023, which helped create a research platform for innovative gene therapy approaches for the condition.

Usher Syndrome affects 25,000 people in the U.S. and is the most common genetic condition worldwide that impacts both hearing and vision in children. Currently, there is no cure for any of the main three types of the condition. UH believes support from the Cynthia and George Mitchell Foundation will help elevate research, advance real-world solutions in health and improve lives.

“What makes UH such a powerful hub for research is not just its own resources, but also its location and strategic partnerships, including those with the Texas Medical Center,” Al-Ubaidi said in a news release. “We have access to an extraordinary network, and that kind of collaborative environment is essential when tackling complex diseases like Usher syndrome, where no single lab can do it alone.”

Members-only coworking club Switchyards to open first Houston location

Where to Work

An innovative take on the coworking space is coming to Houston. Switchyards will open its first location in the Bayou City on Monday, September 29.

Located in the former Buffalo Exchange at 2901 S Shepherd Drive, Switchyards is well located on the border of Montrose, River Oaks, and Upper Kirby. Founded in Atlanta, the Houston location will join 30 outposts in cities such as Austin, Dallas, Denver, Kansas City, and Nashville.

Unlike WeWork, which caters to companies looking for office space for groups of employees, Switchyards pitches itself as a club for individuals who want to get a little work done away from their home offices.

“Working from home all the time is pretty lonesome,” Switchyards creative director Brandon Hinman says. “It feels good to have places to get out and mix it up. To change paces and change scenery.”

Switchyards facilitates that change of scenery with an environment that blends touches of hotel lobbies, college libraries, and coffee shops. As seen in the photos of the company’s other location, the furniture is a mix of desks, comfy chairs, and couches for individuals or small groups. It’s a far cry from the cube farms of the Office Space era.

“They tend to be historic, textured, layered,” Hinman says about the company’s locations. “A lot of really good furniture. Really thoughtful for getting a couple hours of work done.”

Each location features fast wi-fi, plenty of electrical outlets, and good quality coffee and tea. All 250 members have 24/7 access to the space. And by choosing the real estate they lease carefully, Switchyards keeps its membership price to $100 per month.

“Packaging it together like that and opening in these neighborhoods where people actually live has been pretty magical,” Hinman says. "The big opportunity, I think, is that 90 percent of our members have never had a shared space before. It is unlocking a new thing for people.”

Those who are interested in learning more can sign up at switchyards.com/houston-tx to get early access to memberships and an invite to a sneak peek party.

Memberships go on sale Thursday, September 25 at 10 am. Switchyards notes that the last 14 clubs have sold out on day one.

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This story originally appeared on CultureMap.com.

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