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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Intuitive Machines strikes $49.3M deal to expand lunar communications network

space deal

Houston-based Intuitive Machines is bulking up its space-to-ground data network with the acquisition of United Kingdom-based Goonhilly Earth Station and its U.S. arm, COMSAT.

The $49.3 million cash-and-stock deal would add 44 antennas to Intuitive Machines’ network. The acquisition is expected to close in the third quarter.

Intuitive Machines, a space infrastructure and services company, designs, builds, and operates spacecraft and data networks for lunar and deep-space missions. Goonhilly operates a satellite Earth station in Cornwall, England.

Intuitive Machines says Goonhilly’s and COMSAT’s civil, commercial, and government customers will complement its current customer base and broaden its reach into related sectors.

“Customers have been clear that they want a single, integrated, and resilient solution for their communications and [position, navigation, and timing] needs as they accelerate missions at an unprecedented pace,” Steve Altemus, co‑founder and CEO of Intuitive Machines, said in a news release.

Kenn Herskind, executive chairman of Goonhilly, says the acquisition “will allow us to scale that capability globally and directly support the next era of lunar exploration. Together, we will be creating a commercial lunar communications network that is interoperable, resilient, and ready to support Artemis and international missions.”

Modular nuclear reactor co. NuScale Power moves into Houston market

New to Hou

The nuclear energy renaissance continues in Texas with an announcement by NuScale Power. The Oregon-based provider of proprietary and innovative advanced small modular reactor (SMR) nuclear technology announced in April it would be opening office space in Houston’s CityCentre.

“Opening this space in Houston underscores our commitment to meeting rising energy demand with safe, scalable nuclear technology,” John Hopkins, NuScale president and CEO, said in a news release. “This move expands our presence in a key market for partners, prospective customers, and stakeholders in addition to positioning us for the future as we focus on the near-term deployment of our industry-leading technology. Texas is leading the way in embracing advanced nuclear for grid resilience and industrial decarbonization, and we’re proud to expand our footprint and capabilities in this important region.”

Interest in nuclear power has been growing in recent years thanks to tensions with oil-rich nations, concerns about man-made climate change from fossil fuels, and the rapidly increasing power needs of data centers. Both Dow and Texas A&M University have announced expanded nuclear power projects in the last year, with an eye of changing the face of Texas’s energy industry through smaller, safer fission reactors.

Enter NuScale, founded in 2007 from technology developed at the University of Oregon. Their modular SMR technology generates 77 megawatts and is one of the only small modular reactors (SMR) to receive design approval from the U.S. Nuclear Regulatory Commission (NRC). These advances have led to runaway success for NuScale, whose stock has risen by more than 1,670 percent since the start of 2024.

The new operations campus in CityCentre is expected to facilitate the movement, installation and coordination of NuScale technology into the various energy systems. Typically, SMRs are used for off-grid installations, desalination operations, mining facilities and similar areas that lack infrastructure. However, the modularity means that they can be easily deployed to a variety of areas.

It comes none too soon. ERCOT projects that Texas data centers alone will require 77,965 megawatts by 2030.

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This article first appeared on EnergyCapitalHTX.com.

Pharma giant considers Houston for $1 billion manufacturing campus

in the works

Another pharmaceutical giant is considering Houston’s Generation Park for a manufacturing hub.

According to a recent filing with the Texas Jobs, Energy, Technology and Innovation (JETI) program, Bristol Myers Squibb Co. is considering the northeast Houston management district for a new $1 billion multi-modal pharmaceutical manufacturing campus.

If approved, the campus, known as Project Argonaut, could create 489 jobs in Texas by 2031. Jobs would include operations technicians, engineering roles, administrative and management roles, production specialists, maintenance support, and quality control/assurance. The company predicts annual average wages for these positions to be around $96,000, according to the filing.

The project currently includes the 600,000-square-foot facility, but according to the filing, Bristol Myers Squibb “envisions this site growing in scale and capability well beyond its opening configuration."

The Texas JETI program offers companies temporary school property tax limitations in exchange for major capital investment and job creation. E.R. Squibb & Sons LLC applied for a 10-year tax abatement agreement in the Sheldon Independent School District.

The agreement promises a $ 1 billion investment. Construction would begin in 2027 and wrap in 2029.

“The proposed project reflects [Bristol Myers Squibb Co.’s] enduring commitment to bringing innovative medicines to patients and ensuring the long-term supply reliability they depend on,” the filing says. “The proposed project is purpose-built to support and manufacture medicines spanning multiple therapeutic areas and modalities, positioning the site as a long-term launch and commercial campus for decades to come. These medicines will provide therapies to the [Bristol Myers Squibb Co.’s] patients located in markets both nationally and internationally.”

The Fortune 100 company is considering 16 other cities for the new manufacturing facility in the Central and Eastern markets in the U.S. According to the Houston Chronicle, Bristol Myers Squibb Co is still in the “evaluation process” for its potential manufacturing site.

Last fall, Eli Lilly and Co. selected Generation Park for its $6.5 billion manufacturing plant. More than 300 locations in the U.S. competed for the factory. Read more here.

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