CORONAVIRUS RESPONSE

Texas startup’s at-home COVID-19 test finally approved by feds

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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A research team housed out of the newly launched Rice Biotech Launch Pad received funding to scale tech that could slash cancer deaths in half. Photo via Rice University

A research funding agency has deployed capital into a team at Rice University that's working to develop a technology that could cut cancer-related deaths in half.

Rice researchers received $45 million from the National Institutes of Health's Advanced Research Projects Agency for Health, or ARPA-H, to scale up development of a sense-and-respond implant technology. Rice bioengineer Omid Veiseh leads the team developing the technology as principal investigator.

“Instead of tethering patients to hospital beds, IV bags and external monitors, we’ll use a minimally invasive procedure to implant a small device that continuously monitors their cancer and adjusts their immunotherapy dose in real time,” he says in a news release. “This kind of ‘closed-loop therapy’ has been used for managing diabetes, where you have a glucose monitor that continuously talks to an insulin pump. But for cancer immunotherapy, it’s revolutionary.”

Joining Veiseh on the 19-person research project named THOR, which stands for “targeted hybrid oncotherapeutic regulation,” is Amir Jazaeri, co-PI and professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center. The device they are developing is called HAMMR, or hybrid advanced molecular manufacturing regulator.

“Cancer cells are continually evolving and adapting to therapy. However, currently available diagnostic tools, including radiologic tests, blood assays and biopsies, provide very infrequent and limited snapshots of this dynamic process," Jazaeri adds. "As a result, today’s therapies treat cancer as if it were a static disease. We believe THOR could transform the status quo by providing real-time data from the tumor environment that can in turn guide more effective and tumor-informed novel therapies.”

With a national team of engineers, physicians, and experts across synthetic biology, materials science, immunology, oncology, and more, the team will receive its funding through the Rice Biotech Launch Pad, a newly launched initiative led by Veiseh that exists to help life-saving medical innovation scale quickly.

"Rice is proud to be the recipient of the second major funding award from the ARPA-H, a new funding agency established last year to support research that catalyzes health breakthroughs," Rice President Reginald DesRoches says. "The research Rice bioengineer Omid Veiseh is doing in leading this team is truly groundbreaking and could potentially save hundreds of thousands of lives each year. This is the type of research that makes a significant impact on the world.”

The initial focus of the technology will be on ovarian cancer, and this funding agreement includes a first-phase clinical trial of HAMMR for the treatment of recurrent ovarian cancer that's expected to take place in the fourth year of THOR’s multi-year project.

“The technology is broadly applicable for peritoneal cancers that affect the pancreas, liver, lungs and other organs,” Veiseh says. “The first clinical trial will focus on refractory recurrent ovarian cancer, and the benefit of that is that we have an ongoing trial for ovarian cancer with our encapsulated cytokine ‘drug factory’ technology. We'll be able to build on that experience. We have already demonstrated a unique model to go from concept to clinical trial within five years, and HAMMR is the next iteration of that approach.”

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