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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XSpace plans $250M industrial condo expansion with RAFA Racing Club

growth mode

Houston-based XSpace Group has teamed up with two other Houston companies, RAFA Racing Club and Maximo Capital, to develop five industrial condo projects that pair flex space and high-end car storage space with a members-only clubhouse for motorsports enthusiasts.

The five projects will be built in the Dallas-Fort Worth; Miami-Boca Raton; Charlotte-Mooresville, North Carolina; Phoenix-Scottsdale; and Los Angeles markets. Other markets, including Las Vegas, are under consideration for future phases.

XSpace says the initial five-project venture will generate estimated sales of $250 million. Condos will be available to rent or own.

The ground floor of each project will feature a RAFA Racing Club Social & Performance Centre, a members-only clubhouse, event space and lifestyle hub. The remaining floors will offer space for car storage, collectibles, offices and studios. RAFA will operate the ground floor of each building.

“Our goal from day one with RAFA Racing has been to connect people through a shared love of performance and community,” Rafael Martinez, founder of RAFA Racing Club and principal of Maximo Capital, said in a news release. “By pairing XSpace’s forward-thinking condominium design with the exclusive hospitality, networking and high-performance environment of a RAFA Racing Club clubhouse, we’re establishing a community blueprint where passion meets community.”

Each clubhouse will offer:

  • Lounges
  • Dining, working and networking spaces
  • Concierge service
  • Driving simulators
  • Fitness and conditioning capabilities

“We’re building the most valuable community-driven real estate product in America — and RAFA Racing Club is the anchor that makes it unlike anything else on the market," Byron Smith, founder of XSpace, added in a release. “By integrating our flexible, high-end industrial condominiums with RAFA’s world-class hospitality and automotive community spaces, we are completely redefining what commercial real estate can be for the motorsports enthusiast.”

RAFA operates facilities for motorsports fans in Houston and Austin. The clubs, geared toward wealthy people, entrepreneurs, executives, and brand partners, combine a clubhouse, garage, paddock (racing’s version of a locker room), a “human performance” center and driver training programs.

RAFA plans to open seven clubs in the U.S. and three outside the U.S. over the next four years.

XSpace operates a high-end office, warehouse, and lifestyle condo project in Austin and is building a project in Houston that’s set to open in 2027.

Walmart expands drone delivery service to 8 new Houston-area stores

Now Landing

More Walmart delivery drones are now buzzing around Houston-area skies.

In January, Walmart launched its drone delivery service in partnership with Wing at five locations in the Houston area. The retail giant just added eight more stores to its Houston-area drone delivery network.

Wing says the expansion makes drone delivery available to more than 1 million residents of the Houston area. “Many can now bypass notorious Houston traffic to get everyday Walmart essentials delivered by drone in minutes,” Wing said in a release.

The eight Walmart stores that joined the drone delivery network are:

  • 13003 Tomball Pkwy. Houston
  • 12353 FM 1960 Rd. West, Houston
  • 2901 Riley Fuzzel Rd., Spring
  • 20310 U.S. Highway 59, New Caney
  • 1025 Sawdust Rd., Spring, TX 77380
  • 13484 Northwest Fwy., Houston, TX
  • 13750 East Fwy., Houston
  • 3506 Highway 6 South, Houston

Stores where drone delivery was already available are:

  • 14215 FM 2100 Rd., Crosby
  • 1313 N. Fry Rd., Katy
  • 15955 FM 529 Rd., Houston
  • 255 FM 518, Kemah
  • 6060 N. Fry Rd., Katy

Houstonians can learn whether their address is eligible for drone delivery from a Walmart store by visiting wing.com/walmart. Drone-delivered orders can be placed on the Walmart app, the Wing app, or at Walmart.com.

Once an order is ready, it’s loaded onto a delivery drone. The drone then flies up to 60 mph and at a cruising altitude of about 150 feet to reach the customer’s home. The average flight takes less than 5 minutes.

Once it arrives at the customer’s home, the drone stops, hovers at roughly 23 feet, and lowers the order via a tether. Wing says its drones gently lower orders to the ground to protect fragile items like eggs and coffee.

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This article originally appeared on CultureMap.com.

TMC expands Korea BioBridge, welcomes 12 biotech companies to Houston

welcome to hou

The powerful partnership between Texas Medical Center (TMC) innovation and the world of Korean biotech advancement is already growing in scope. Just six months after the new TMC Republic of Korea BioBridge was first announced, 12 new companies from the Republic of Korea will establish on-site presences in Houston to further collaboration between the two nations and medical industries.

The expansion comes from a new agreement between TMC and the Korea Health Industry Development Institute (KHIDI). William McKeon, president and CEO of Texas Medical Center, applauded the move and predicted it would benefit both Houston and Korea immensely.

“Korea has established itself as a global leader in biohealth innovation, with a growing pipeline of breakthrough technologies across digital health, biotechnology, and medical devices,” McKeon said in the news release. “Through the TMC Korea BioBridge, we are creating a direct connection between Korea’s innovators and the world’s largest medical city. This collaboration between TMC and KHIDI provides companies with a place to establish a presence, build strategic relationships, engage with leading clinicians and researchers, and accelerate the path toward commercialization and patient impact in the United States.”

The companies that will be in residence at the TMC Innovation Factory include Ardens Lifescience, whose new CAROL device is currently in human trials tackling lung cancer by using the airway network as electrodes to perform bronchoscopic ablation; stem cell-based gene therapy firm CELLeBRAIN, currently working on neurological disorders and solid cancers; and Wellysis, the developer of the S-Patch wearable cardiac monitoring device.

Additional companies include:

  • Antigravity
  • ARPI
  • CTCELLS
  • elecell
  • HUVER Inc.
  • Hutom
  • ORGANOIDSCIENCES
  • YOUTH BIO GLOBAL
  • Seoul Medical Informatics Intelligence Lab Inc.

“This collaboration establishes a strong foundation for connecting Korea’s biohealth innovation ecosystem with world-class clinical and innovation resources in the United States,” Younghun Jeong, executive director of the KHIDI, added in the news release. “Through partnerships with Texas Medical Center and the Korean-American Medical Association Texas, we look forward to fostering meaningful collaboration among innovators, clinicians, and industry leaders while creating new opportunities for clinical validation, commercialization, and global growth. KHIDI remains committed to expanding global partnerships that support biohealth innovation, clinical collaboration, commercialization, and international growth.”

This is the seventh international strategic partnership for the TMC. It launched its first BioBridge with the Health Informatics Society of Australia in 2016. It launched its TMC Japan BioBridge, focused on advancing cancer treatments, last year. It also has BioBridge partnerships with the Netherlands, Ireland, Denmark and the United Kingdom.

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