The FDA-authorized, saliva-based COVID-19 RT-PCR test expands testing access with a comfortable, at-home alternative - eliminating in-person waits and reducing exposure risk
The FDA-authorized, saliva-based COVID-19 RT-PCR test expands testing access with a comfortable, at-home alternative - eliminating in-person waits and reducing exposure risk
DEERFIELD, Ill. and LENEXA, Kan., Feb. 24, 2021 /PRNewswire/ -- Clinical Reference Laboratory (CRL), one of the largest privately held clinical testing laboratories in the U.S., and Walgreens today announced that the FDA-authorized CRL Rapid Response COVID-19 Saliva Test is now available through Walgreens Find Care®, a digital health platform available on the Walgreens app and Walgreens.com. Sold under CRL’s HealthConfirm® brand, the COVID-19 Saliva Test is non-invasive and highly accurate, offering consumers the convenience of self-collecting the test right in their homes without supervision.
“Testing continues to be a critical tool to keep Americans safe even as the vaccine rolls out,” said Robert Thompson, CEO at Clinical Reference Laboratory. “The HealthConfirm®-branded COVID-19 Saliva Test uses Clinical Reference Laboratory’s PCR testing technology, which demonstrated highly accurate results with 100 percent sensitivity and specificity in its FDA EUA filing. Our goal is to make the test as accessible and convenient as possible to encourage consistent, widespread testing.”
Using Walgreens Find Care®, individuals can connect with CRL’s website to order the test if they meet one or more of the clinical guidelines for COVID-19 testing by completing a short online questionnaire. Once the kit arrives, individuals register their test online, deposit a sample of their saliva in the provided collection vial and then drop the sample off using the prepaid FedEx Priority Overnight shipping package at their local FedEx locations. Results are typically available within 24-48 hours of receipt at the lab through a secure portal and are also delivered directly to individuals’ mobile phone via text or landline by voice message. For those who test positive, an independent telemedicine provider will reach out to provide critical next steps including the option to speak with a licensed physician. The test costs $119 per kit.
“Increasing access to COVID-19 testing is a priority for Walgreens and CRL’s at-home test provides a convenient way to offer testing and care when and how patients need it,” said Giovanni Monti, Senior Vice President of Healthcare Services, Walgreens Boots Alliance. “This adds to the growing list of healthcare and COVID offerings available through Walgreens Find Care to help our communities access care when and how they need it.”
The HealthConfirm®-branded COVID-19 Saliva Test leverages the same FDA-authorized Clinical Reference Laboratory COVID-19 PCR testing technology used by numerous organizations across various industries including major universities and school districts, top financial institutions, film and TV productions as well as casinos and more.
Walgreens Find Care® helps patients manage their healthcare from the comfort of their own home, including accessing convenient in-person and virtual doctor visits for a range of services, like urgent care, telehealth, physician second opinions, mental health and even optical services. The platform offers an integrated healthcare and pharmacy experience to empower people to get care when and how they need it from local and national providers they trust, all through the convenience of the Walgreens mobile app or online at Walgreens.com/findcare.
Currently through Walgreens Find Care®, patients can access more than 45 trusted providers that together offer more than 65 services and treat more than 120 conditions. The launch of additional features and providers on Walgreens Find Care® coincided with guidance from the Centers for Disease Control and Prevention (CDC) to use telehealth to help address medical needs while supporting social distancing, an important step in managing the impact of COVID-19. Walgreens currently offers COVID-19 testing in 3,500 drive-thru locations across the country.
CRL’s Rapid Response COVID-19 Saliva Test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by Clinical Reference Laboratory, Inc., located in Lenexa, Kan.; has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Similar to other tests with FDA EUAs currently in the market, this test has not been formally FDA cleared or approved.
About HealthConfirm® and the CRL Rapid Response COVID-19 Saliva Test
Clinical Reference Laboratory received FDA Emergency Use Authorization (EUA) for its saliva-based COVID-19 RT-PCR test in July 2020. In the FDA filing, the test demonstrated 100 percent sensitivity and specificity. The test incorporates technology from trusted partners DNA Genotek and Co-Diagnostics. Saliva samples are collected in a DNA Genotek OMNIgene® ORAL (OM-505) saliva collection device and tested via patented CoPrimer™ probes and primers developed by Co-Diagnostics (NASDAQ: CODX) to detect SARS-CoV-2 (the virus that causes COVID-19) viral RNA. Clinical Reference Laboratory has distributed and processed more than 500,000 tests to date across multiple industries including education (K-12 & universities), film & TV, financial institutions, manufacturers, governments (state & local) and professional sports, among many others.
About Clinical Reference Laboratory
Clinical Reference Laboratory (CRL) is one of the largest privately held clinical testing laboratories in the U.S., performing hundreds of thousands of tests every day for clients large and small. Our staff of more than 700 associates works around-the-clock to process and report results seven days a week for many of the largest retail, transportation, pharmaceutical, healthcare and financial service organizations in the world. From high-complexity molecular diagnostic COVID-19 testing, to our toxicology and general lab testing, our partners are as diverse as the testing we perform. In late 2020, CRL acquired Confirm BioSciences, a leading provider of high-quality, comprehensive screening tools and solutions, including its health and wellness testing portfolio HealthConfirm®. CRL’s mission isn’t to be the most recognized laboratory partner, but to be the most trusted by providing personalized service, accurate testing, rapid turnaround time, and innovative systems and solutions. CRL is a CLIA certified and CAP accredited laboratory. Visit us at: https://www.crlcorp.com or call 833-567-8376 for more information.
About Walgreens
Walgreens (www.walgreens.com) is included in the Retail Pharmacy USA Division of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), a global leader in retail and wholesale pharmacy. As America’s most loved pharmacy, health and beauty company, Walgreens purpose is to champion the health and wellbeing of every community in America. Operating more than 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving approximately 8 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with platforms bringing together physical and digital, supported by the latest technology to deliver high-quality products and services in local communities nationwide.
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SOURCE Clinical Reference Laboratory; Walgreens
Company Codes: NASDAQ-SMALL:CODX, NASDAQ-NMS:WBA
