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.

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MD Anderson makes AI partnership to advance precision oncology

AI Oncology

Few experts will disagree that data-driven medicine is one of the most certain ways forward for our health. However, actually adopting it comes at a steep curve. But what if using the technology were democratized?

This is the question that SOPHiA GENETICS has been seeking to answer since 2011 with its universal AI platform, SOPHiA DDM. The cloud-native system analyzes and interprets complex health care data across technologies and institutions, allowing hospitals and clinicians to gain clinically actionable insights faster and at scale.

The University of Texas MD Anderson Cancer Center has just announced its official collaboration with SOPHiA GENETICS to accelerate breakthroughs in precision oncology. Together, they are developing a novel sequencing oncology test, as well as creating several programs targeted at the research and development of additional technology.

That technology will allow the hospital to develop new ways to chart the growth and changes of tumors in real time, pick the best clinical trials and medications for patients and make genomic testing more reliable. Shashikant Kulkarni, deputy division head for Molecular Pathology, and Dr. J. Bryan, assistant professor, will lead the collaboration on MD Anderson’s end.

“Cancer research has evolved rapidly, and we have more health data available than ever before. Our collaboration with SOPHiA GENETICS reflects how our lab is evolving and integrating advanced analytics and AI to better interpret complex molecular information,” Dr. Donna Hansel, division head of Pathology and Laboratory Medicine at MD Anderson, said in a press release. “This collaboration will expand our ability to translate high-dimensional data into insights that can meaningfully advance research and precision oncology.”

SOPHiA GENETICS is based in Switzerland and France, and has its U.S. offices in Boston.

“This collaboration with MD Anderson amplifies our shared ambition to push the boundaries of what is possible in cancer research,” Dr. Philippe Menu, chief product officer and chief medical officer at SOPHiA GENETICS, added in the release. “With SOPHiA DDM as a unifying analytical layer, we are enabling new discoveries, accelerating breakthroughs in precision oncology and, most importantly, enabling patients around the globe to benefit from these innovations by bringing leading technologies to all geographies quickly and at scale.”

Houston company plans lunar mission to test clean energy resource

lunar power

Houston-based natural resource and lunar development company Black Moon Energy Corporation (BMEC) announced that it is planning a robotic mission to the surface of the moon within the next five years.

The company has engaged NASA’s Jet Propulsion Laboratory (JPL) and Caltech to carry out the mission’s robotic systems, scientific instrumentation, data acquisition and mission operations. Black Moon will lead mission management, resource-assessment strategy and large-scale operations planning.

The goal of the year-long expedition will be to gather data and perform operations to determine the feasibility of a lunar Helium-3 supply chain. Helium-3 is abundant on the surface of the moon, but extremely rare on Earth. BMEC believes it could be a solution to the world's accelerating energy challenges.

Helium-3 fusion releases 4 million times more energy than the combustion of fossil fuels and four times more energy than traditional nuclear fission in a “clean” manner with no primary radioactive products or environmental issues, according to BMEC. Additionally, the company estimates that there is enough lunar Helium-3 to power humanity for thousands of years.

"By combining Black Moon's expertise in resource development with JPL and Caltech's renowned scientific and engineering capabilities, we are building the knowledge base required to power a new era of clean, abundant, and affordable energy for the entire planet," David Warden, CEO of BMEC, said in a news release.

The company says that information gathered from the planned lunar mission will support potential applications in fusion power generation, national security systems, quantum computing, radiation detection, medical imaging and cryogenic technologies.

Black Moon Energy was founded in 2022 by David Warden, Leroy Chiao, Peter Jones and Dan Warden. Chiao served as a NASA astronaut for 15 years. The other founders have held positions at Rice University, Schlumberger, BP and other major energy space organizations.

Houston co. makes breakthrough in clean carbon fiber manufacturing

Future of Fiber

Houston-based Mars Materials has made a breakthrough in turning stored carbon dioxide into everyday products.

In partnership with the Textile Innovation Engine of North Carolina and North Carolina State University, Mars Materials turned its CO2-derived product into a high-quality raw material for producing carbon fiber, according to a news release. According to the company, the product works "exactly like" the traditional chemical used to create carbon fiber that is derived from oil and coal.

Testing showed the end product met the high standards required for high-performance carbon fiber. Carbon fiber finds its way into aircraft, missile components, drones, racecars, golf clubs, snowboards, bridges, X-ray equipment, prosthetics, wind turbine blades and more.

The successful test “keeps a promise we made to our investors and the industry,” Aaron Fitzgerald, co-founder and CEO of Mars Materials, said in the release. “We proved we can make carbon fiber from the air without losing any quality.”

“Just as we did with our water-soluble polymers, getting it right on the first try allows us to move faster,” Fitzgerald adds. “We can now focus on scaling up production to accelerate bringing manufacturing of this critical material back to the U.S.”

Mars Materials, founded in 2019, converts captured carbon into resources, such as carbon fiber and wastewater treatment chemicals. Investors include Untapped Capital, Prithvi Ventures, Climate Capital Collective, Overlap Holdings, BlackTech Capital, Jonathan Azoff, Nate Salpeter and Brian Andrés Helmick.

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This article originally appeared on our sister site, EnergyCapitalHTX.com.

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