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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Pharma giant considers Houston for $1B 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.

Houston health tech co. lands NIH grant for AI cancer prediction tool

fresh funding

Houston-based CellChorus and Stanford Medicine were recently awarded a Phase I Small Business Innovation Research grant for the company's AI platform to test how certain cancer patients will respond to therapies.

The funding comes from the National Cancer Institute of the National Institutes of Health. According to a filing, the grant totaled just under $400,000.

CellChorus, which spun out from the University of Houston’s Technology Bridge, has developed TIMING (Time-lapse Imaging Microscopy In Nanowell Grids), which analyzes the behavior of thousands of individual immune cells over time and can identify early indicators of treatment success or failure.

The company will work with Stanford's Dr. David Miklos and Dr. Saurabh Dahiya, who have built the Bone Marrow Transplantation and Cell Therapy Biobank. The biobank manages and stores biological samples from patients treated at their clinic and in clinical trials.

"Predicting which patients will achieve durable responses after CAR-T therapy remains one of the most important challenges in the field,” Miklos said in a news release. “We aim to uncover functional cellular signatures that can guide treatment decisions and improve patient outcomes.”

The project will specifically profile cells from patients with relapsed/refractory large B-cell lymphoma (r/rLBCL). According to CellChorus, only about half of r/rLBCL patients who receive CAR-T therapy "achieve a durable, long-term remission." Others do not respond to therapy or experience relapse.

“The sooner we know whether a cancer therapy is working, the better. To maximize patient benefit, we need technology that can provide a robust and early prediction of response to therapy. The technology needs to be scalable, cost-efficient, and capable of rapid turnaround times,” Rebecca Berdeaux, chief scientific officer of CellChorus, added in the release. “We are excited to work with Drs. David Miklos and Saurabh Dahiya and their colleagues on this very important project.”

CellChorus has previously received SBIR grants from federal agencies, including a $2.5 million award in 2024 from its National Center for Advancing Translational Sciences (NCATS) and a $2.3 million SBIR Fast-Track award from the National Institute of General Medical Sciences in 2023.

Houston museum showcases America's founding documents in rare exhibit

Experience History

As the United States prepares to celebrate its 250th birthday, Houstonians have a chance to see rare documents from the founding of the nation. Freedom Plane National Tour: Documents That Forged a Nation, presented by the National Archives Foundation, will be on display at the Houston Museum of Natural Science through Monday, May 25.

The collection includes a rare engraving of the original Declaration of Independence; official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton; a draft of the Bill of Rights; the Treaty of Paris, the documented that recognized America's independence from Great Britain; and the tally of votes approving the Constitution.

The National Archives specifically chose Houston as one of only eight cities in the country to host the exhibit as a means to help the documents reach a wider audience outside of the main hub of semiquincentennial events in New England and the Washington, D.C. area.

"One of the things we decided when we put the tour together because we wanted to be off the East Coast," said Patrick Madden, CEO of the National Archives Foundation, who was onsite for the exhibit's opening in Houston. "There's a lot of 250th celebration stuff happening in the original 13 colonies. How do we get it to major markets where larger numbers of people can see it? So in the case of Houston, obviously, [is a] major market in this part of the country, but also we've partnered with the museum twice before with National Archives exhibits, so we knew that they would be up to the task of handling the exhibit and the crowds."

The star of the collection is a rare engraving of the original Declaration of Independence. Secretary of State and future president John Quincy Adams commissioned 200 exact replicas of the document from engraver William J. Stone in 1823. Less than 50 now remain. Madden joyfully pointed out that there are errors in this document, a potent reminder that the men who forged a nation made mistakes.

"There's a couple of typos in it where they had to make corrections," said Madden. "So even the founders, you know, they're all human. That resonates because here these people are making this move against the most powerful nation in the world and putting their lives on the line for a country based on ideas."

Other impressive parts of the collection include official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton, as well as one of the drafts of the Bill of Rights. Many states would not ratify the Constitution until certain rights were included in the document, leading to Washington going on a national tour assuring state leaders enshrining protections was first on the list. The draft copy on display specifically shows the First Amendment in progress.

Houston is the fourth stop on the exhibition's tour, which will take the documents to Denver, Miami, Dearborn, and Seattle through the summer. Freedom Plane is just one part of a larger patriotic celebration at the HMNS, which includes a film series celebrating American science and culture and general Americana decoration throughout the main hall.

Admission to Freedom Plane is free to the public, but separate from general admission to the museum. Space is limited, and passes are available on a first-come, first-serve basis. Non-members should expect long waits or the possibility that the day's passes are sold out. Only museum members can reserve passes for specific times. Flash photography is prohibited due to the fragile nature of the documents.

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This article originally appeared on CultureMap.com.

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