GRAIL's Galleri Test Now
Directly Available to Physicians in the U.S. Through Collaboration
With Quest Diagnostics, Delivering a More Streamlined Provider and
Patient Experience
MENLO
PARK, Calif. and SECAUCUS,
N.J., Feb. 12, 2025 /PRNewswire/ -- GRAIL, Inc.
(Nasdaq: GRAL), a healthcare company whose mission is to detect
cancer early when it can be cured, and Quest Diagnostics (NYSE:
DGX), a leading provider of diagnostic information services, today
announced the initial phase of a program to improve provider access
to GRAIL's Galleri® multi-cancer early detection (MCED)
test. Providers can now order the Galleri test directly from GRAIL
through the Quest Diagnostics connectivity system. The Quest
Diagnostics connectivity system enables providers in the United States to order and receive reports
of laboratory tests electronically through Quest's Quanum
laboratory portal and more than 900 electronic health record (EHR)
systems. More than 500,000 providers used the Quest connectivity
system last year.
The integration will help streamline the process of ordering the
Galleri test for physicians. It will also increase availability by
allowing patients access to the test at any of Quest's
approximately 7,400 patient access points nationwide. Patients with
a test order from their physician can now go directly to Quest
without needing to bring a Galleri test kit to the blood draw
appointment.
"Quest Diagnostics and GRAIL share a commitment to improving
access to cancer screening and have worked productively together to
enable patient access to GRAIL's Galleri test via Quest's
phlebotomy network since 2021," said Mark
Gardner, Senior Vice President, Molecular Genomics and
Oncology for Quest Diagnostics. "Integrating GRAIL's Galleri test
into the Quest connectivity system is the next step in this
collaboration. We expect it to increase patient access by giving
Quest's provider clients the ability to seamlessly order the test
through Quest, same as they do for other blood work. This
collaboration brings to life the tremendous value of Quest's
ability to scale diagnostic innovation to make it accessible for
all."
Cancers growing in the body shed DNA into the bloodstream. These
DNA fragments act like a unique "fingerprint" of cancer. With a
single blood draw, the Galleri test screens for the "fingerprint"
of many of the deadliest cancers before they become symptomatic,
including those with no recommended screening tests today. It can
also provide doctors with information on the cancer's origin to
help predict the tissue type or organ associated with the cancer
signal. The Galleri test is prescription only, recommended for
adults with an elevated risk for cancer, such as those age 50 or
older, and is to be used in addition to recommended cancer
screenings.
"We know every minute counts for busy providers, their staff and
their patients, which is why we're so pleased to work with Quest to
offer a seamless experience that fits into providers' existing
ordering process," said Josh Ofman,
MD, MSHS, President at GRAIL. "While today there are recommended
screenings for five cancers, nearly 70% of deaths are caused by
cancers with no recommended screening test. We believe this
integration will help to make it easier to incorporate the Galleri
test into routine exams to help screen for cancer before it becomes
symptomatic when outcomes may be improved."
About Quest Diagnostics
Quest Diagnostics works
across the healthcare ecosystem to create a healthier world, one
life at a time. We provide diagnostic insights from the results of
our laboratory testing to empower people, physicians and
organizations to take action to improve health outcomes. Derived
from one of the world's largest databases of de-identifiable
clinical lab results, Quest's diagnostic insights reveal new
avenues to identify and treat disease, inspire healthy behaviors
and improve healthcare management. Quest Diagnostics annually
serves one in three adult Americans and half the physicians and
hospitals in the United States,
and our more than 55,000 employees understand that, in the right
hands and with the right context, our diagnostic insights can
inspire actions that transform lives and create a healthier world.
www.QuestDiagnostics.com.
About GRAIL
GRAIL is a healthcare company whose
mission is to detect cancer early, when it can be cured. GRAIL is
focused on alleviating the global burden of cancer by using the
power of next-generation sequencing, population-scale clinical
studies, and state-of-the-art machine learning, software, and
automation to detect and identify multiple deadly cancer types in
earlier stages. GRAIL's targeted methylation-based platform can
support the continuum of care for screening and precision oncology,
including multi-cancer early detection in symptomatic patients,
risk stratification, minimal residual disease detection, biomarker
subtyping, treatment and recurrence monitoring. GRAIL is
headquartered in Menlo Park, CA
with locations in Washington,
D.C., North Carolina, and
the United Kingdom.
For more information, visit grail.com.
About Galleri®
The Galleri multi-cancer early detection test is a proactive tool
to screen for cancer. With a simple blood draw, the Galleri test
can identify DNA shed by cancer cells, which can act as a unique
"fingerprint" of cancer, to help screen for some of the deadliest
cancers that don't have recommended screening today, such as
pancreatic, esophageal, ovarian, liver, and others.* The Galleri
test can be used to screen for cancer before a person becomes
symptomatic, when cancer may be more easily treated and potentially
curable. The Galleri test can indicate the origin of the cancer,
giving healthcare providers a roadmap of where to explore further.
The Galleri test requires a prescription from a licensed healthcare
provider and should be used in addition to recommended cancer
screenings such as mammography, colonoscopy, prostate-specific
antigen (PSA) test, or cervical cancer screening. The Galleri test
is recommended for adults with an elevated risk for cancer, such as
those aged 50 or older.
For more information, visit galleri.com.
Sensitivity in study participants with –
Pancreas cancer: 83.7% overall (61.9% stage I, 60.0% stage II,
85.7% stage III, 95.9% stage IV). Esophagus cancer 85.0% overall
(12.5% stage I, 64.7% stage II, 94.7% stage III, 100% stage IV).
Ovary cancer: 83.1% overall (50.0% stage I, 80.0% stage II, 87.1%
stage III, 94.7% stage IV). Liver/bile duct cancer: 93.5% overall
(100% stage I, 70.0% stage II, 100% stage III, 100% stage IV).
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated
risk for cancer, such as those aged 50 or older. The Galleri test
does not detect all cancers and should be used in addition to
routine cancer screening tests recommended by a healthcare
provider. Galleri is intended to detect cancer signals and predict
where in the body the cancer signal is located. Use of Galleri is
not recommended in individuals who are pregnant, 21 years old or
younger, or undergoing active cancer treatment.
Results should be interpreted by a healthcare provider in the
context of medical history, clinical signs and symptoms. A test
result of No Cancer Signal Detected does not rule out cancer. A
test result of Cancer Signal Detected requires confirmatory
diagnostic evaluation by medically established procedures (e.g.
imaging) to confirm cancer.
If cancer is not confirmed with further testing, it could mean
that cancer is not present or testing was insufficient to detect
cancer, including due to the cancer being located in a different
part of the body. False-positive (a cancer signal detected when
cancer is not present) and false-negative (a cancer signal not
detected when cancer is present) test results do occur. Rx
only.
Laboratory/Test Information
The GRAIL clinical laboratory is certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) and accredited by
the College of American Pathologists. The Galleri test was
developed and its performance characteristics were determined by
GRAIL. The Galleri test has not been cleared or approved by the
Food and Drug Administration. The GRAIL clinical laboratory is
regulated under CLIA to perform high-complexity testing. The
Galleri test is intended for clinical purposes.
GRAIL Forward Looking Statements
This press release contains forward-looking statements. In some
cases, you can identify these statements by forward-looking words
such as "aim," "anticipate," "believe," "continue," "could,"
"estimate," "expect," "intend," "may," "might," "plan,"
"potential," "predict," "should," "would," or "will," the negative
of these terms, and other comparable terminology. These
forward-looking statements, which are subject to risks,
uncertainties, and assumptions about us, may include statements
about benefits of the integration between the Quest connectivity
system and Galleri.
These statements are only predictions based on GRAIL's current
expectations and projections about future events and trends. There
are important factors that could cause our actual results, level of
activity, performance, or achievements to differ materially and
adversely from those expressed or implied by the forward-looking
statements, including those factors discussed under the section
entitled "Risk Factors" in GRAIL's most recent Quarterly Report on
Form 10-Q filed with the SEC. Moreover, GRAIL operates in a dynamic
and rapidly changing environment. New risks emerge from time to
time. It is not possible for GRAIL's management to predict all
risks, nor can they assess the impact of all factors on GRAIL's
business or the extent to which any factor, or combination of
factors, may cause actual results, level of activity, performance,
or achievements to differ materially and adversely from those
contained in any forward-looking statements GRAIL may make.
Forward-looking statements relate to the future and,
accordingly, are subject to inherent uncertainties, risks, and
changes in circumstances that are difficult to predict and many of
which are outside of GRAIL's control. Although GRAIL believes the
expectations and projections expressed or implied by the
forward-looking statements are reasonable, GRAIL cannot guarantee
future results, level of activity, performance, or achievements.
GRAIL's actual results and financial condition may differ
materially from those indicated in the forward-looking statements.
Except to the extent required by law, GRAIL undertakes no
obligation to update any of these forward-looking statements after
the date of this press release to conform its prior statements to
actual results or revised expectations or to reflect new
information or the occurrence of unanticipated events.
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SOURCE GRAIL, Inc.
