SECAUCUS, N.J., July 18, 2020 /PRNewswire/ -- Quest
Diagnostics (NYSE: DGX), the world's leading provider of
diagnostic information services, today announced that it has
received emergency use authorization (EUA) from the U.S. Food and
Drug Administration (FDA) to use specimen pooling with its
proprietary molecular diagnostic test for COVID-19. Quest is the
first lab provider to receive FDA authorization for the technique
for COVID-19 testing in the United
States.
In pooling, specimens must still be collected into individual
vials, but then are combined into small batches or pools by the
laboratory. A negative result for a batch means that all patients
in that pool are considered negative (If a positive result
occurs for the batch, each specimen is retested individually). The
technique is an efficient way to evaluate patients in regions or
populations with low rates of disease. Pooling is used routinely in
blood banking to screen donated blood for a variety of viruses,
among other applications.
With the new pooling EUA, the Quest Diagnostics SARS-CoV-2 RNA
("Quest SARS-CoV-2 rRT-PCR") test* may be used with pooled upper
respiratory specimens (nasopharyngeal, mid-turbinate, anterior
nares or oropharyngeal swabs). **In clinical data presented by
Quest to the FDA, none of 3,091 total specimens from a population
with a prevalence rate of 1-10 percent, if pooled, would have been
incorrectly determined to be negative (95%CI 0.0-0.1%).
The company expects to deploy the technique at its laboratories
in Chantilly, VA and Marlborough, Mass., by the end of next week
with additional laboratories to follow.
"As COVID-19 continues to spread around the country, access to
timely, quality laboratory testing is critical to patients and an
effective public health response," said Steve Rusckowski, Chairman, CEO and President,
Quest Diagnostics. "Pooled specimen testing is a proven technique
that will help us to optimize testing capacity at this critical
time for our country."
"We applaud FDA for taking this important step to empower Quest
to increase capacity across our national laboratory network," said
Jay G. Wohlgemuth, M.D., Senior Vice
President and Chief Medical Officer, Quest Diagnostics. "Pooling
will help expand testing capacity but it is not a magic bullet, and
testing times will continue to be strained as long as soaring
COVID-19 test demand outpaces capacity. Each of us can practice
behaviors that will reduce COVID-19 infections in our communities,
so our national healthcare system can better respond to this
crisis."
On July 13, 2020, Quest issued a
statement that soaring demand for COVID-19 molecular
diagnostics is slowing turnaround times to report results.
FDA EUAs for Telemedicine Self-Collection
Yesterday, the FDA also granted three emergency use authorizations
to Quest Diagnostics for the use of its Quest Diagnostics
Self-Collection Kit with the Hologic Panther Fusion, Hologic Aptima
and Roche cobas molecular platforms. The new EUAs expand the use of
the self-collection kit beyond the EUA, granted on May 27th, for the use of the kit on the Quest
SARS-CoV-2 rRT-PCR test. The company expects the new EUAs will
allow it to use self-collection more broadly on behalf of clients
and patients in the United States.
Self-collected specimens that were not observed by a healthcare
professional are not eligible for pooling.
New FDA EUAs Follows EUAs for Other Quest Innovations
Quest Diagnostics is a leader in infectious disease testing
services, with a broad menu of molecular, antibody, and other test
services to aid diagnosis, treatment and monitoring. The new FDA
EUAs follow several others received by the company for its COVID-19
test innovations.
In March 2020, Quest received FDA
EUA for The Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time
RT-PCR ("Quest SARS-CoV-2 rRT-PCR"), a real-time RT-PCR test
intended for the qualitative detection of nucleic acid from the
SARS-CoV-2 in upper and lower respiratory specimens collected from
individuals suspected of COVID-19 by their healthcare provider. In
May 2020, the company received an FDA
EUA to use the test nasal swab specimens that are self-collected at
home or in a healthcare setting by individuals using an authorized
home-collection kit when determined to be appropriate by a
healthcare provider.
*The Quest Diagnostics molecular test and self-collection kit
have not been FDA cleared or approved, have been authorized by FDA
under an EUA, and have been authorized only for the detection of
nucleic acid from SARS-CoV-2, not for any other viruses or
pathogens. The test and self-collection kit are only authorized for
the duration of the declaration that circumstances exist justifying
the authorization of emergency use of in vitro diagnostic tests for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of
the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
**The Quest Diagnostics molecular test is also for use with
pooled samples containing up to four individual upper respiratory
swab specimens (nasopharyngeal, mid-turbinate, anterior nares
or oropharyngeal swabs) collected under observation in individual
vials containing transport media from individuals suspected of
COVID-19 by their healthcare provider. Negative results from pooled
testing should not be treated as definitive. If patient's
clinical signs and symptoms are inconsistent with a negative result
or results are necessary for patient management, then the patient
should be considered for individual testing. Specimens included in
pools with a positive, inconclusive, or invalid result must be
tested individually prior to reporting a result. Specimens with low
viral loads may not be detected in sample pools due to the
decreased sensitivity of pooled testing.
About Our COVID-19 Testing
Quest Diagnostics is at the forefront of the response to the
COVID-19 pandemic, working to broaden access to laboratory insights
to help us all lead healthier lives. We provide both molecular
diagnostic and antibody serology tests to aid in the diagnosis of
COVID-19 and immune response. Our COVID-19 test services are based
on tests that have received FDA emergency use authorization and
which also meet our high standards for quality. We are providing
these test services under the Public Readiness and Emergency
Preparedness Act. We provide data on COVID-19 testing to various
federal and state public health authorities, including the Centers
for Disease Control and Prevention, and participate in studies with
government and private institutions, aiding COVID-19 public
health response and research. Through our team
of dedicated phlebotomists, air fleet team, couriers and laboratory
professionals, Quest Diagnostics works hard every day to help
patients and communities across the United States access
quality COVID-19 testing.
For more information about the latest developments with our
COVID-19 testing, visit:
newsroom.questdiagnostics.com/COVIDTestingUpdates
About Quest Diagnostics
Quest Diagnostics empowers people to take action to improve health
outcomes. Derived from the world's largest database of clinical lab
results, our diagnostic insights reveal new avenues to identify and
treat disease, inspire healthy behaviors and improve health care
management. Quest annually serves one in three adult Americans and
half the physicians and hospitals in the United States,
and our 47,000 employees understand that, in the right hands and
with the right context, our diagnostic insights can inspire actions
that transform lives. www.QuestDiagnostics.com
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