Study Participants from
Veteran Affairs Sites Include a Diverse Population With
Toxic Exposure
MENLO
PARK, Calif., Oct. 23,
2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL), a
healthcare company whose mission is to detect cancer early when it
can be cured, today announced early results from the
REFLECTION study, which aims to understand the real-world
experience of the Galleri® multi-cancer early detection (MCED)
test in routine clinical settings. The Galleri test is recommended
for adults with an elevated risk for cancer, such as those age 50
or older. In this study, a diverse population of veterans
from U.S. Department of Veterans Affairs (VA) sites with toxic
exposure but with no symptoms suggestive of cancer were included in
study enrollment. Initial results showed that among study
participants, the veteran cohort had a cancer signal detection rate
consistent with other populations that have received the MCED test.
The findings were presented during a presentation at the 2024 Early
Detection of Cancer Conference (EDCC).
Overall, the cancer signal detection rate in this veteran cohort
was 1.30% (37/2854 participants; 95% CI: 0.94% - 1.78%), which is
consistent with other populations that have received the MCED test
(0.88%1 and 0.95%2). Among the 37
participants with a Cancer Signal Detected (CSD) at the time of
analysis, 28 completed 180 days of follow-up, and of these, 12
cancer diagnoses were confirmed. More than half of the cases were
identified at early stages (I-III) and the most common cancer
signal of origin prediction was lung cancer (7). A positive
predictive value (PPV), meaning that the test accurately detects a
signal for cancer in someone that has cancer, was 42.9%, which is
consistent with PPVs from previous Galleri testing
datasets.1,3 Additional cancers could be diagnosed
during the remainder of the one-year follow-up period.
"While today doctors screen individually for five specific
cancers, nearly 70% of cancers have no recommended screening tests.
With 50,000 veterans diagnosed with cancer every year, these
initial findings from REFLECTION showing a consistent cancer signal
detection rate among the veteran cohort suggest that when added to
recommended screenings, MCED tests like Galleri may address an
unmet medical need," said Charles
Atwood, M.D., pulmonologist and lead researcher on the
REFLECTION study at VA Pittsburgh.
"We look forward to longer-term data that will provide
veteran-reported experience with MCED testing and cancer outcomes
that may provide additional insights for veterans with
service-related toxic exposures."
The REFLECTION study (NCT05205967) is a multi-center,
prospective, non-interventional, cohort study designed to
understand the real-world experience of Galleri in clinical
settings. This initial analysis included data from seven VA sites
with 180 days of post-test follow-up. A total of 2,924 veterans
were enrolled in the study at the time of the analysis and 2,854
are analyzable in these initial study data. Within the veteran
cohort with data, 70% of participants had been exposed to one
or more toxic environmental or occupational hazards during their
service, including open burn pits/airborne hazards, Gulf
War-related exposures, Agent Orange, radiation and others. The
study included recruitment of veterans aged ≥22 years. The mean age
of the cohort was 60 years old and the cohort was 79% male.
"With many veterans at elevated risk of developing cancer, the
initial results from the REFLECTION study provide important
insights into the impact of MCED testing to help transform early
cancer detection in a real-world setting," said Josh Ofman, MD, MSHS, President at GRAIL. "We're
honored to be working with the VA, the largest national integrated
health system in the U.S., to evaluate how Galleri can screen for
many of the deadliest cancers before they become symptomatic, when
there may be more treatment options."
About the REFLECTION Study
REFLECTION is a
multi-center, prospective, non-interventional, cohort study that
will enroll approximately 17,000 individuals who have opted to be
screened with the Galleri, multi-cancer early detection (MCED) test
in routine clinical settings. The purpose of the study is to
understand the real-world experience of Galleri in clinical
settings. Patients who have been prescribed the Galleri test as
part of medical care by their healthcare provider will have the
opportunity to consent for participation into this data collection
study and will be actively followed for 12 months from the time of
enrollment through data capture from electronic health records and
periodic self-report questionnaires.
About GRAIL, Inc.
GRAIL, Inc. 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 in finding cancer early.
With a simple blood draw, the Galleri test can identify DNA shed by
cancer cells (unique "fingerprints") 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. It is recommended
for people over the age of 50, or those with an elevated risk for
cancer due to genetics, family history, environmental exposure, or
other risk factors.
For more information about Galleri, visit galleri.com
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 U.S. 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.
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
expectations and projections of test performance , clinical study
results, regulatory compliance, potential market opportunity,
anticipated growth strategies, and anticipated trends in our
business.
These statements are only predictions based on our 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 the Quarterly Report on Form 10-Q for
the period ended June 30, 2024 and in
GRAIL's other filings with the U.S. Securities and Exchange
Commission (the "SEC") . Moreover, we operate in a dynamic and
rapidly changing environment. New risks emerge from time to time.
It is not possible for our management to predict all risks, nor can
we assess the impact of all factors on our 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 we 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 our control. Although we believe the
expectations and projections expressed or implied by the
forward-looking statements are reasonable, we cannot guarantee
future results, level of activity, performance, or achievements.
Our actual results and financial condition may differ materially
from those indicated in the forward-looking statements. Except to
the extent required by law, we undertake no obligation to update
any of these forward-looking statements after the date of this
press release to conform our prior statements to actual results or
revised expectations or to reflect new information or the
occurrence of unanticipated events. Footnotes:
- Schrag D et al. Lancet. 2023;402(10409):1251-1260.
- Westgate C et al. Poster presented at American Society of
Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023, Chicago, IL.
- Klein et al. Ann Oncol. 2021;32(9):1167-1177.
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