Everlywell Signs Agreement to Distribute FDA-Authorized Rapid Antigen Testing for Organizations and Public Health Agencies
The company also unveiled a newly expanded suite of enterprise tools to help organizations stay safe and compliant, including new features designed to assist with testing logistics, deployment, reporting, and compliance
AUSTIN, Texas, Jan. 8, 2021 /PRNewswire/ -- Everlywell, a leading digital health company and provider of one of the only FDA-authorized at-home sample collection kits for COVID-19, today announced it has signed an agreement to work with Concentric by Ginkgo, the biosecurity and health delivery platform of Ginkgo Bioworks, and their partner, innovative testing and distribution company Intrivo Diagnostics, to bring Access Bio's FDA-authorized CareStart COVID-19 Antigen test to workplaces, clinics, schools, government offices and health plans.
The CareStart™ COVID-19 Antigen test from Access Bio is designed to be administered by healthcare professionals and includes a disposable rapid antigen testing lateral flow device to detect active COVID-19 infection in as little as 15 minutes. The agreement will enable Everlywell to distribute the rapid antigen test to organizations in need of diagnostic tests for COVID-19.
Following receipt of the first FDA emergency use authorization of its kind for its COVID-19 Test Home Collection Kit in May, Everlywell's enterprise line of business has supplied COVID-19 testing to over 250 organizations, including some of the largest health plans in the nation. As part of today's announcement, the company unveiled new digital tools to help organizations stay safe and compliant, along with new features for its reporting platform, Everlywell Lens, which debuted earlier in 2020 and has been used at universities, workplaces, and organizations across the country to support safer reopening or continued operations. The company now offers the following solutions for organizations in need of testing, reporting and compliance tools:
The Everlywell COVID-19 Test Home Collection Kit: An FDA-authorized RT-PCR test that results in 24-72 hours after processing at a CLIA-certified lab, digitally enabled by the Everlywell platform. Shipping both ways is included, including overnight shipping to the lab.
The CareStart™ COVID-19 Antigen test from Access Bio: An FDA-authorized rapid antigen test that results in as little as 15 minutes and is designed to be administered by a healthcare provider.
Coming soon: The Cellex qSARS-COV-2 Antigen Rapid Test, pending Cellex's receipt of an Emergency Use Authorization from the FDA.
Enterprise Tools for Organizations
Everlywell Lens Everlywell Lens is a comprehensive reporting dashboard that helps organizations test their participants for COVID-19, certain chronic conditions (including diabetes and colon cancer), or certain infectious diseases (such as STDs) at scale. Everlywell Lens provides visibility into the status of individual tests, from registration to digital results. Everlywell's solution also helps organizations stay compliant with federal and local reporting requirements by automatically transmitting test results to mandated agencies using a HIPAA-compliant interface. Additionally, the program administrators at each organization receive real-time alerts as positive or abnormal test results become available, helping to direct attention to those who need it most. Everlywell's digital interface allows participants to easily share their results to gain entry into workplaces or events where a negative COVID-19 test result is required, and organizations can confirm these results in Lens.
Everlywell Opt-In Portal This digital solution was designed to help organizations facilitate online distribution and shipment of at-home test kits, regardless of the manufacturer. The Everlywell Opt-In Portal can be customized for each organization, allowing individual participants to input their shipping information via their organization's unique landing page. Everlywell then fulfills each order directly by shipping tests to participants for home use, if desired. A helpful component of this solution is the ability for participants to opt into sharing their test results with their organization, enabling the organization to see positive results in their COVID-19 testing program.
Telehealth Consults Individuals who receive positive results on any COVID-19 tests offered through Everlywell will be offered a telehealth consult with an independent physician to discuss next steps, included in the cost of the test. Results discussions or telehealth consults with registered healthcare professionals are also included in the cost of each kit in the rest of Everlywell's test menu.
Customer Support Organizations who work with Everlywell to provide testing programs have access to Everlywell's team of highly trained support representatives for their testing staff and test-takers. Everlywell's enterprise customer support team was recently named one of the top B2B support teams in North America based on customer satisfaction.
Everlywell believes Americans deserve access to affordable lab tests and insightful, digitally-enabled results with actionable next steps. The company connects individuals to certified labs offering a suite of validated lab tests including Cholesterol, Heart Health, Fertility, STIs, Lyme Disease, Testosterone, Thyroid and more. Everlywell offers one of the only FDA-authorized at-home sample collection test kits for COVID-19, and was the first to provide access to at-home sample collection lab tests for fertility, high-risk HPV, and indoor & outdoor allergies. 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 and engagement programs 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.