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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Houston researchers develop breakthrough device that could bypass spinal injuries

breakthrough research

Scientists at Houston Methodist have announced a significant leap forward for spinal cord injury recovery.

The researchers have developed a device that essentially bypasses spinal injuries, allowing signals from previously “lost” functions to reach the brain, a new study published in Nature Communications shows.

“Most current technologies try to improve whatever function remains after a spinal cord injury,” Dr. Damiano Barone, assistant professor of neurosurgery in the Department of Neurosurgery at Houston Methodist and co-lead on the study, said in a news release. “Our goal is different. Rather than fixing the injury itself, we want to bypass it completely and create an alternative route for signals to travel.”

The study involved a single ultrathin circumferential electrode array made to conform around the spinal cord without penetrating neural tissue, which was implanted into rodent and pig models with spinal injuries. The electrode array was able to interpret motor, sensory and autonomic signals around the injury. Think of it as a set of detours that restore road access to isolated towns after a disaster destroys the highway instead of just rebuilding the highway.

Over the course of three days, the arrays detected signals of intended movement from low-frequency spinal oscillations with more than 94 percent accuracy. This worked across species and was replicated in feasibility studies on human cadavers.

This research could serve as a new foundation for neuroprosthetic implants that could restore connectivity to the 2.5 million people worldwide suffering from spinal injuries that result in loss of ability. Future development could result in everything from restored organ function to mobility, according to Houston Methodist.

George Malliaras, the Prince Professor of Technology in the Department of Engineering at the University of Cambridge, who co-led the study, sees it as a fundamental restructuring of the science of spinal trauma.

“This could represent a paradigm change in how we think about spinal cord injuries,” Malliaras said. “Instead of starting from the idea that what is lost is gone forever, this approach asks whether we can restore function by carrying the signal around the injury.”

Further work involving laboratory models will need to be completed before launching human trials.

Grants from the National Institutes of Health, Houston Methodist Katz Investigator Award, Helaers Research Award and the Engineering and Physical Sciences Research Council helped support the study. Other collaborators on the study include Salim Hadwe, Ruben Serrano, George Psaltakis, Margaux Forner, Chaeyeon Lee, Sydney Swedick, Moleca Ghnnam, Tawfique Hasan and Alejandro Carnicer-Lombarte from the University of Cambridge; and Anton Banta and Xueer Zhang from Houston Methodist.

Abbott assembles expert team to help lure U.S. Space Academy to Texas

space race

State Rep. Greg Bonnen of Friendswood has been tapped to lead a new team that will promote Texas as the future home of the U.S. Space Academy.

Bonnen, a neurosurgeon, chairs Houston Physicians’ Hospital and the powerful Texas House Appropriations Committee. His House district is close to NASA’s Johnson Space Center.

Gov. Greg Abbott appointed the seven-member team. Last month, President Trump signed an executive order establishing the Presidential Commission on the U.S. Space Academy. Commission members, who held their first meeting this month, will recommend a permanent location for the academy.

Texas officials are pushing a site near Johnson Space Center to host the academy. Alabama, Colorado and Florida are among Texas’ competitors.

In a joint statement, U.S. Sen. Ted Cruz and U.S. Rep. Brian Babin, both of Texas, issued a statement backing the state’s bid for the academy. Cruz lives in Houston. Babbin lives in Woodville, about 55 miles south of Beaumont.

“America’s space program is built across the country, but Texas is where the pieces come together,” the lawmakers said. “We are ready to lead the next generation of space pioneers and look forward to showing why Texas is the right home for the U.S. Space Academy.”

The academy’s curriculum will include technical education, leadership development and public service components. Graduates will be set up for careers in the U.S. military, civil service, and aerospace sectors.

The Abbott-appointed team will work with the Texas Space Commission to prepare the state’s proposal for the academy.

In addition to Bonnen, team members with ties to Houston include:

  • Robert Ambrose, who grew up in Houston. He worked at Johnson Space Center before becoming associate director of the Texas A&M Space Institute.
  • Former NASA astronaut Nancy Curry-Gregg, director of the Texas A&M Space Institute. She earned a doctoral degree from the University of Houston and previously worked at Johnson Space Center.
  • Former NASA astronaut Jack Fischer, senior vice president of Houston-based Intuitive Machines. The company builds spacecraft, delivers payloads to the moon and launches satellites.

“Texas is the home of America’s human spaceflight program,” Abbott said in a release. “No state can match what Texas brings to this mission.”

“NASA’s Johnson Space Center, world-class universities, a premier commercial space industry, major military installations, and an unmatched aerospace workforce give Texas every asset the United States Space Academy requires,” the governor added.