OSUR: Direct to Consumer COVID Saliva PCR Test

LENEXA, Kan. , Nov. 9, 2020 /PRNewswire/ -- Today, Clinical Reference Laboratory (CRL), one of the largest privately held clinical testing laboratories in the U.S., announced that it has begun selling its best-in-class CRL Rapid Response ™ saliva-based COVID-19 RT-PCR test directly to consumers. At $110 (which includes the cost of prepaid FedEx Priority Overnight shipping in both directions), the easy-to-use, highly accurate test is one of the most affordable COVID-19 home tests currently available in the market and the least expensive at-home saliva test.


"Through our ongoing work with organizations and businesses nationwide, we saw that there was high demand for a reliable, convenient test that can be self-collected at home," said Robert Thompson , CRL CEO. "Individual consumers no longer have to wait in line or make appointments to get an invasive swab test when they can conduct an easier saliva-based one right in their own homes."

The CRL Rapid Response ™ saliva-based COVID-19 RT-PCR test is for symptomatic individuals or those who believe they may have been exposed. The test simply requires that the individual's saliva be deposited in a collection vial provided and sent to CRL using the provided prepaid one-day shipping package. Results are typically available within 24 hours of receipt at the lab and can be accessed online through a unique two-factor authentication protected portal—accessible by computer or mobile device. For those who test positive, Cynergy, a telemedicine provider, will reach out to provide critical next-step information including the option to speak with a licensed physician about their results. Prior to taking the test, individuals will need to give consent for the telemedicine provider and their local public health departments to receive the test results.

"People can be confident that CRL gets their results right, using highly sensitive and accurate RT-PCR testing from a CLIA and CAP certified laboratory," said Heather Fehling , PhD, CRL's Chief Scientific Officer, Molecular Diagnostics. "In our FDA filing, we were able to demonstrate that CRL Rapid Response ™ had the highest sensitivity and specificity. Our test was at least as accurate as nasopharyngeal swabs and far more accurate than the shorter anterior nasal swabs, which are used in most at-home COVID tests ."

CRL Rapid Response ™ offers convenient self-testing with better sample collection, protection and transport, combined with superior testing methodology incorporating technology from trusted partners Co-Diagnostics and DNA Genotek that ultimately leads to the most accurate results.

Individual CRL Rapid Response ™ tests can be purchased through the website order.CRLcorp.com . For group purchases, email covidtesting@crlcorp.com or call 833- 567-8376.

Since receiving FDA Emergency Use Authorization (EUA) in July, CRL has distributed and processed over 150,000 CRL Rapid Response ™ tests across multiple industries including education (K-12 & universities), film & TV, financial institutions, manufacturers, governments (state & local) and professional sports, among many others. The test can be used in virtually any setting, and doesn't use uncomfortable nasopharyngeal swabs, which require that testing be done by a health professional in full personal protective equipment (PPE) and depend on the test taker's technique in order to get accurate results .

With CRL Rapid Response ™, saliva is collected in a DNA Genotek OMNIgene ® ORAL (OM-505) saliva collection device, specifically designed for self-collection, stabilization, storage and shipment to the laboratory. Studies conducted by CRL and DNA Genotek, a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), demonstrate sample stability of up to twenty-one days post-collection, enabling at-home collection. CRL tests the saliva sample by RT-PCR (reverse transcriptome-polymerase chain reaction) technology, using Patented CoPrimer™ probes and primers developed by CRL partner Co-Diagnostics Inc. (NASDAQ: CODX) to detect SARS-CoV-2 (the virus caused by COVID-19) viral RNA with high sensitivity and specificity.

Clinical Reference Laboratory 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. Our 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. Visit us at: www.crlcorp.com or call 833-567-8376 for more information.