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 says it will prioritize giving its at-home COVID-19 tests to healthcare professionals. Photo by Siri Stafford/Getty Images

Texas startup provides COVID-19 home-testing kits at no cost to medical professionals

now testing

The on-again, off-again launch of a coronavirus test from Austin startup Everlywell is on again — sort of.

On March 23, Everlywell was supposed to start shipping 30,000 test kits to U.S. consumers. But before a single test was sent, the U.S. Food and Drug Administration (FDA) blocked the distribution of at-home, self-administered tests from Everlywell and other companies.

Now, the Austin-based company is making the tests available primarily to hospitals and other healthcare providers in the U.S. to meet a "desperate need" for front-line medical professionals to be tested.

"In this evolving health crisis, our highest priority is to ensure that the people at highest risk get the accurate testing and care they need," Michelle Davey, CEO of Wheel Health, says in a March 23 release.

Everlywell says that effective March 23, its test is available only to hospitals and healthcare providers that offer it at no cost to their front-line workers, along with high-risk patients who exhibit coronavirus symptoms.

The company, which produces a variety of at-home lab tests, says its shift from testing of consumers to testing of healthcare workers and high-risk patients is "critically important" to help prevent the spread of what's known as the novel coronavirus. The virus causes the highly contagious and potentially deadly COVID-19 respiratory illness.

It's been a confusing few days since Everlywell announced it was making at-home tests for consumers. On March 20, the FDA said it hadn't authorized at-home, self-administered coronavirus tests from Everlywell or any other company. Three days later, on March 23, Dr. Deborah Birx, coronavirus coordinator for the White House, announced the federal government was clearing the way for self-swabbing coronavirus tests such as those made by Everlywell.

In a series of tweets March 23, Everlywell said it's working with the FDA on "a path forward" for at-home coronavirus tests of consumers.

"The FDA sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection," the federal agency says, "and we are actively working with test developers in this space."

Everlywell unveiled a $1 million program design to spur labs to speed up development of an at-home coronavirus diagnostic test. Many labs answered the call, allowing Everlywell to set up a coronavirus testing and diagnosis system in a matter of days. For consumers, each test will cost $135. Some providers of health savings accounts and flexible spending accounts will cover these tests.

Eventually, Everlywell wants to ship 250,000 tests per week.

At the same time, another Austin startup, Wheel Health, and Houston-based Microdrop have unveiled a partnership that will provide at-home coronavirus testing administered by licensed healthcare professionals, rather than consumers themselves, and supported by telemedicine technology. The federally approved product is geared toward people at high risk of the coronavirus or people with limited access to testing. For now, it's available only in Texas.

The test from Wheel, a telehealth provider, and Microdrop, a producer of at-home health tests, also costs $135. At the outset, the companies will roll out 5,000 test kits in Texas. After that, they plan to sell 10,000 test kits per week. Nationwide, the companies hope to offer 100,000 test kits per week by the end of April.

"Providing accurate medical guidance to people who are concerned about, or may have been exposed to, COVID-19 will determine the way this pandemic plays out in our country — and collaboration is essential to mobilizing toward this common goal rapidly and efficiently," says Dr. Rafid Fadul, chief medical officer of Wheel.

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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California-based healthcare co. expands to Houston with new bioskills lab

med skills

Axis Research & Technologies, a California-based healthcare innovation solutions and medical research company, has expanded into the Houston area via a new 10,800-square-foot bioskills lab in Shenandoah last month.

The facility includes a main lab that’s configurable into a single space with over 20 stations, two more lab suites for specialized bioskills training, a conference room for presentations and a large multipurpose area.

Medical professionals can simulate a fully functional operating room in the lab for training and education. It also has the capability of handling cadaver specimens.

The company says the new facility aims to serve surgeons, medical device companies, hospitals and research institutions.

Axis was attracted to Houston thanks to the Texas Medical Center and other world-class medical groups, according to a release from the company. The facility in Shenandoah will be near medical facilities in The Woodlands.

“We are thrilled to expand into the Houston market,” Jill Goodwin, COO of Axis, said in a news release. “This new facility was driven by demand from our clients who have expressed a need for a high-quality bioskills lab in Houston. We repeatedly heard this feedback at the most recent American Academy of Orthopaedic Surgeons (AAOS) conference, which reinforced our decision to bring Axis to the region.”

Axis hosted its first lab event at its Houston-area venue on Feb. 22. The facility is currently accepting bookings for medical trainings, research collaborations and use of its bioskills lab.

“Our goal is to create an environment where groundbreaking medical advancements can take place,” Goodwin added in a news release. “Houston is home to one of the largest medical communities in the country, making it a perfect fit for our expansion.”

Axis' other bioskills labs are located in Nasvhille; Irvine, California; and Columbia, Maryland.

Texas institute grants $12M to bring leading cancer researchers to Houston

cha-ching

Rice University has recruited a prominent Swedish cancer researcher thanks to a $6 million grant from the Cancer Prevention and Research Institute of Texas.

It’s among $68 million in research grants recently awarded by the state agency, and six recruitment grants totaling $16 million to bring leading cancer researchers to Texas.

A news release from the Cancer Prevention and Research Institute of Texas (CPRIT) describes Pernilla Wittung-Stafshede of the Chalmers University of Technology in Gothenburg, Sweden, as “an accomplished and highly gifted biophysical scientist tackling complicated biological questions regarding the role of metals and metal dysregulation in various diseases. She pioneered a new research field around the role of metal ions in the folding and function of metalloproteins.”

Metalloproteins account for nearly half of all proteins in biology, according to the National Institutes of Health. They “catalyze some of the most difficult and yet important functions in [nature], such as photosynthesis and water oxidation,” the federal agency says.

Wittung-Stafshede, a professor of chemical biology and life sciences at Chalmers, is a former professor at Rice.

Aside from the money for Wittung-Stafshede, Houston recruitment grants also went to:

  • University of Texas M.D. Anderson Cancer Center: $2 million to recruit Rosalie Griffin of the Mayo Clinic
  • Baylor College of Medicine: $2 million to recruit Dr. Nipun Verma of the Yale University School of Medicine
  • Baylor College of Medicine: $2 million to recruit Xin “Daniel” Gao of Harvard University and the Massachusetts Institute of Technology

In Houston, cancer research grants were given to:

  • Baylor College of Medicine: $7.8 million
  • M.D. Anderson Cancer Center: $20.7 million
  • Rice University: $ 1 million
  • University of Houston: $1.2 million
  • University of Texas Health Science Center at Houston: $4.5 million

“The awards … represent the depth and diversity of CPRIT funding for cancer research in Texas,” says Kristen Doyle, CEO of CPRIT. “These grants develop new approaches to preventing, diagnosing, treating, and surviving cancer for all Texans.”

See the full list of awards here.