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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Rice University researchers unveil new model that could sharpen MRI scans

MRI innovation

Researchers at Rice University, in collaboration with Oak Ridge National Laboratory, have developed a new model that could lead to sharper imaging and safer diagnostics using magnetic resonance imaging, or MRI.

In a study recently published in The Journal of Chemical Physics, the team of researchers showed how they used the Fokker-Planck equation to better understand how water molecules respond to contrast agents in a process known as “relaxation.” Previous models only approximated how water molecules relaxed around contrasting agents. However, through this new model, known as the NMR eigenmodes framework, the research team has uncovered the “full physical equations” to explain the process.

“The concept is similar to how a musical chord consists of many notes,” Thiago Pinheiro, the study’s first author, a Rice doctoral graduate in chemical and biomolecular engineering and postdoctoral researcher in the chemical sciences division at Oak Ridge National Laboratory, said in a news release. “Previous models only captured one or two notes, while ours picks up the full harmony.”

According to Rice, the findings could lead to the development and application of new contrast agents for clearer MRIs in medicine and materials science. Beyond MRIs, the NMR relaxation method could also be applied to other areas like battery design and subsurface fluid flow.

“In the present paper, we developed a comprehensive theory to interpret those previous molecular dynamics simulations and experimental findings,” Dilipkumar Asthagiri, a senior computational biomedical scientist in the National Center for Computational Sciences at Oak Ridge National Laboratory, said in the release. ”The theory, however, is general and can be used to understand NMR relaxation in liquids broadly.”

The team has also made its code available as open source to encourage its adoption and further development by the broader scientific community.

“By better modeling the physics of nuclear magnetic resonance relaxation in liquids, we gain a tool that doesn’t just predict but also explains the phenomenon,” Walter Chapman, a professor of chemical and biomolecular engineering at Rice, added in the release. “That is crucial when lives and technologies depend on accurate scientific understanding.”

The study was backed by The Ken Kennedy Institute, Rice Creative Ventures Fund, Robert A. Welch Foundation and Oak Ridge Leadership Computing Facility at Oak Ridge National Laboratory.

Houston-area lab grows with focus on mobile diagnostics and predictive medicine

mobile medicine

When it comes to healthcare, access can be a matter of life and death. And for patients in skilled nursing facilities, assisted living or even their own homes, the ability to get timely diagnostic testing is not just a convenience, it’s a necessity.

That’s the problem Principle Health Systems (PHS) set out to solve.

Founded in 2016 in Clear Lake, Texas, PHS began as a conventional laboratory but quickly pivoted to mobile diagnostics, offering everything from core blood work and genetic testing to advanced imaging like ultrasounds, echocardiograms, and X-rays.

“We were approached by a group in a local skilled nursing facility to provide services, and we determined pretty quickly there was a massive need in this area,” says James Dieter, founder, chairman and CEO of PHS. “Turnaround time is imperative. These facilities have an incredibly sick population, and of course, they lack mobility to get the care that they need.”

What makes PHS unique is not only what they do, but where they do it. While they operate one of the largest labs serving skilled nursing facilities in the state, their mobile teams go wherever patients are, whether that’s a nursing home, a private residence or even a correctional facility.

Diagnostics, Dieter says, are at the heart of medical decision-making.

“Seventy to 80 percent of all medical decisions are made from diagnostic results in lab and imaging,” he says. “The diagnostic drives the doctor’s or the provider’s next move. When we recognized a massive slowdown in lab results, we had to innovate to do it faster.”

Innovation at PHS isn’t just about speed; it’s about accessibility and precision.

Chris Light, COO, explains: “For stat testing, we use bedside point-of-care instruments. Our phlebotomists take those into the facilities, test at the bedside, and get results within minutes, rather than waiting days for results to come back from a core lab.”

Scaling a mobile operation across multiple states isn’t simple, but PHS has expanded into nine states, including Texas, Oklahoma, Kansas, Missouri and Arizona. Their model relies on licensed mobile phlebotomists, X-ray technologists and sonographers, all trained to provide high-level care outside traditional hospital settings.

The financial impact for patients is significant. Instead of ambulance rides and ER visits costing thousands, PHS services often cost just a fraction, sometimes only tens or hundreds of dollars.

“Traditionally, without mobile diagnostics, the patient would be loaded into a transportation vehicle, typically an ambulance, and taken to a hospital,” Dieter says. “Our approach is a fraction of the cost but brings care directly to the patients.”

The company has also embraced predictive and personalized medicine, offering genetic tests that guide medication decisions and laboratory tests that predict cognitive decline from conditions like Alzheimer's and Parkinson’s.

“We actively look for complementary services to improve patient outcomes,” Dieter says. “Precision medicine and predictive testing have been a great value-add for our providers.”

Looking to the future, PHS sees mobile healthcare as part of a larger trend toward home-based care.

“There’s an aging population that still lives at home with caretakers,” Dieter explains. “We go into the home every day, whether it’s an apartment, a standalone home, or assisted living. The goal is to meet patients where they are and reduce the need for hospitalization.”

Light highlighted another layer of innovation: predictive guidance.

“We host a lot of data, and labs and imaging drive most treatment decisions,” Light says. “We’re exploring how to deploy diagnostics immediately based on results, eliminating hours of delay and keeping patients healthier longer.”

Ultimately, innovation at PHS isn’t just about technology; it’s about equity.

“There’s an 11-year life expectancy gap between major metro areas and rural Texas,” Dieter says. “Our innovation has been leveling the field, so everyone has access to high-quality diagnostics and care, regardless of where they live.”

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