LENEXA, Kan., July 31, 2020 /PRNewswire/ -- Today,
Clinical Reference Laboratory (CRL), one of the largest privately
held clinical testing laboratories in the U.S., announced that it
received FDA Emergency Use Authorization (EUA) and is scaling up
capacity for CRL Rapid Response™, a saliva-based COVID-19
RT-PCR test that can be self-collected at home, work or any other
setting. The test, shown in CRL's EUA studies to be more sensitive
and accurate than the standard COVID-19 anterior nasal swab test,
detects the presence of coronavirus in the saliva of the test
taker. In addition, the test is more comfortable and easier to
administer, is not "technique dependent" and virtually anyone can
self-collect an adequate sample for testing, with test results
available in 24-48 hours of receipt at CRL. CRL Rapid
Response™ is ready for immediate commercial launch, making it
the first large-scale service of its kind focused on the American
workforce. Testing is critical to safely helping America get
back to work, which is why CRL is offering these tests to
employers in businesses, universities, government agencies, nursing
homes and other organizations. CRL has already lined up several
partnerships for CRL Rapid Response™ testing.
In CRL conducted studies of paired samples required for the FDA
EUA, the CRL Rapid Response™ test had 100% sensitivity
and specificity (higher than any other saliva-based COVID-19
molecular diagnostic test) — accurately detecting the presence or
absence of the virus in known COVID-19 positive and negative
patients as compared to only 55% detection using anterior nasal
swabs, the common method of self-collection. The higher sensitivity
and accuracy of the CRL Rapid Response™ saliva test is due
to a combination of factors. First, saliva typically contains a
larger sample of genetic material than what is usually collected
using an anterior nasal swab. Additionally, collection of a CRL
sample is not technique dependent and can be easily self-collected.
The 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
technology, using Patented CoPrimer™ probes and primers developed
by CRL partner Co-Diagnostics Inc. (NASDAQ: CODX) to detect
SARS-CoV-2 viral RNA with high sensitivity and specificity.
"Experts agree that testing is the key to getting America back
to work, but concerns about reliability and availability of testing
are an impediment for many states, cities and businesses as they
consider their re-opening plans," said CRL CEO Robert Thompson. "FDA authorization of the
CRL Rapid Response™ saliva test answers the call on both
fronts with a convenient, highly accurate test that can be
self-collected, supported by a world-class CLIA certified and CAP
accredited clinical laboratory accustomed to providing testing on a
large scale. Our over thirty-year track record of delivering high
quality and accurate testing enables us to manufacture, deploy and
process the tests very quickly. We currently service employers and
insurance companies by processing over 300,000 tests a day and we
are aggressively scaling up for mass COVID-19 testing in the next
2-3 weeks, and expect to eventually process over 50,000 tests a
day."
"People should not have to choose between comfort or convenience
and accuracy. CRL Rapid Response™ offers convenient
self testing with better sample collection, protection and
transport, combined with superior testing methodology, which leads
to more accurate results and, ultimately, better public health
outcomes," said Dr. Heather Fehling,
CRL's Chief Scientific Officer, Molecular Diagnostics. "Together
with our partners Co-Diagnostics and OraSure DNA Genotek, we are
committed to providing the most accurate and user-friendly testing
process available. We believe this test will make a meaningful
difference in our nation's ability to re-open safely."
CRL Rapid Response™ tests can be purchased by government
agencies, universities, and businesses for their employees. The
test itself is easy to use and simply requires that the
individual's saliva be deposited in a collection vial provided and
sent back to the CRL laboratories using the company provided
prepaid one-day shipping package. Specimens are processed within
24-48 hours of receipt and individuals can access their test
results online through a unique two-factor authentication protected
portal. Individuals have the option to speak with a licensed
physician about their results. Prior to taking the test,
individuals will need to give consent for their employers and their
local public health departments to receive the test results.
About Clinical Reference Laboratory:
Clinical
Reference Laboratory is one of the largest privately held clinical
testing laboratories in the U.S. With dedicated facilities in
North America and Europe, and through our global laboratory
partners, we perform hundreds of thousands of tests every day for
clients large and small. Our staff of more than 600 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. Visit us at: https://www.crlcorp.com or call
833-567-8376 for more information.
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SOURCE Clinical Reference Laboratory (CRL)