Everlywell issued the following announcement on May 18.
Everlywell, the digital health company which offers individuals access to at-home collection lab tests for cholesterol, diabetes, STIs, hormones, and more, today announced that the company has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a COVID-19 at-home collection kit. Everlywell's EUA is the first to be issued to a digital health company such as Everlywell, which connects people and organizations with laboratory testing and is not a laboratory or diagnostics manufacturer. It is also the only EUA for at-home collection COVID-19 testing that is not tied to one specific lab and allows the company to work with a number of certified labs offering several authorized tests, rather than being limited to a single laboratory or a single test.
"We appreciate the FDA's close partnership and guidance in issuing this authorization, which is the first EUA for a digital health company such as Everlywell," said Dr. Frank Ong, Chief Medical and Scientific Officer at Everlywell. "Working with a growing number of authorized laboratories over time enables Everlywell to scale COVID-19 testing for Americans where they need it most - in their homes."
The at-home sample collection kit authorized by this EUA enables individuals to obtain a molecular PCR test designed to diagnose the presence or absence of the virus that causes COVID-19 through one of the company's FDA-authorized laboratory partners. Everlywell's collection kit uses a short nasal swab and includes a digital screening questionnaire reviewed by a healthcare provider, instructions on how individuals can safely ship their samples to the lab, digital results within 48 hours of the sample being received by the lab, and results reviewed by an independent physician. Positive test results will include a telehealth consult and be reported to the appropriate mandated federal and local public health agencies.
The company will use at least two CLIA-certified high-complexity partner laboratories to process tests at launch, with the intention of adding more laboratory partners as they receive authorization from the FDA for tests using Everlywell's at-home sample collection kit. More information about Everlywell's EUA can be found here.
As with the company's COVID-19 test offering for healthcare providers and organizations, this test kit will also be offered at no profit to Everlywell. The $109 price will cover its costs, such as overnight shipping to the lab, lab processing fees, physician review and diagnosis, and kit components. Everlywell will provide the information necessary for patients to submit a claim to their insurance company to seek reimbursement for the cost of the test, although coverage will depend on individuals' insurance policies. The cost of the test will be covered by participating FSA and HSA plans.
Everlywell believes COVID-19 testing should be available at no cost and is working with Congress to find a legislative solution to limitations that prevent companies like Everlywell, which provides access to testing but is neither a medical provider or a laboratory providing COVID-19 testing services, from being directly reimbursed by insurers. The company has also reached out to policymakers to explore funding possibilities for making the tests 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," said Julia Cheek, CEO and Founder of Everlywell.
The company will also continue to supply qualifying healthcare organizations with access to testing. Qualifying healthcare organizations and government organizations in need of COVID-19 tests for samples collected by a healthcare provider can visit this link to learn more. Individuals interested in Everlywell's at-home COVID-19 collection test can sign up to receive updates here.
About Everlywell
Everlywell believes consumers deserve access to affordable lab tests and insightful, digitally-enabled results with actionable next steps. The company connects consumers to lab partners offering a suite of validated lab tests including Cholesterol, Heart Health, Fertility, STIs, Lyme Disease, Testosterone, Thyroid and more. Prices are straightforward starting at $49 and tests are generally covered by Flexible Spending and Health Savings Accounts. Physician-reviewed, actionable test results from CLIA-certified labs are provided within days of sample receipt. The company also provides testing for health plans, healthcare organizations, and employers, including some of the largest health plans in the nation.
The Austin-based company was founded in 2015 and is advised by a Scientific Advisory Board that includes some of the nation's top scientists from Harvard, MIT, Google and NYU. Everlywell was selected as one of Fast Company's Most Innovative Companies in 2019.
For more information please visit www.everlywell.com.
Original source can be found here.
