Data Support Clinical Performance of
Galleri to Detect More Aggressive Prostate
Cancers
MENLO
PARK, Calif., Aug. 29,
2024 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL) a
healthcare company whose mission is to detect cancer early when it
can be cured, today announced that detailed findings of the
performance of its Galleri® multi-cancer early detection
(MCED) test in prostate cancer were published in JCO Precision
Oncology. The data support the clinical performance of the
Galleri test to preferentially screen for aggressive, clinically
significant prostate cancer as compared to slow-growing (indolent)
cases in the Circulating Cell-free Genome Atlas (CCGA) and
PATHFINDER studies.
![GRAIL, Inc. is a healthcare company whose mission is to detect cancer early when it can be cured. (PRNewsfoto/GRAIL, Inc.) GRAIL, Inc. is a healthcare company whose mission is to detect cancer early when it can be cured. (PRNewsfoto/GRAIL, Inc.)](https://mma.prnewswire.com/media/2460831/Grail_Logo.jpg)
"All screening tests run the risk of overdiagnosis. In the case
of prostate cancer, this is largely due to the high prevalence of
low-grade, indolent cancers," said Brandon
Mahal, M.D., a radiation oncologist at Sylvester
Comprehensive Cancer Center, part of the University of Miami Miller School of Medicine, and
lead author of the study. "The results of this study demonstrate
that the use of MCED tests in a population-based screening program
is unlikely to contribute to overdiagnosis of slow-growing prostate
cancers that may not need treatment. That being said, clinically
validated MCED tests like Galleri reveal that when a prostate
cancer signal is detected, it usually indicates aggressive disease
and additional diagnostic evaluation is necessary."
The published data is from an analysis of 420 prostate cancer
patients identified in the independent clinical validation portion
(substudy 3) of the multi-center, case-control observational study
Circulating Cell-free Genome Atlas (CCGA) study and 18 cases from
the prospective intended-use PATHFINDER study. The data were
previously presented at the American Association for Cancer
Research (AACR) Annual Meeting in March 2024.
Results from this analysis showed that of the prostate cancers
that were detected by the MCED test, most were clinically
significant (93% were intermediate or high grade and 67% were stage
III or IV). For detected prostate cancers, the cancer signal of
origin (CSO) prediction accuracy was > 90%. Detectability for
stage I and II cancers were 4.2% across both studies combined,
which is expected with low shedding prostate cancer tumor fraction
and is consistent with cfDNA literature in prostate cancer. Test
sensitivity of prostate cancer for all stages was 11.2% in substudy
CCGA-3. Notably, the MCED test detected no low-grade cancers, 1.9%
of intermediate-grade cancers, and only 4.2% of stage I and II
cancers across both studies combined. Of the detected cases, 93%
were Gleason grade groups 3-5. This analysis demonstrates the MCED
test preferentially detects high-grade, clinically significant
prostate cancer. This is important because an MCED test, when used
in addition to standard-of-care screening, should not exacerbate
overdiagnosis of indolent cancers. These findings also suggest that
individuals with a cancer signal detected and a prostate CSO
prediction should undergo a prompt diagnostic evaluation to
determine the presence of aggressive disease for which treatment is
generally indicated1.
"This prostate cancer analysis underscores the power of Galleri
in a general population of men at-risk for prostate cancer as it is
able to detect biologically significant cancers that need treatment
without potentially contributing to the burden of overdiagnosis,"
said Dr. Eric Klein, Distinguished
Scientist at GRAIL and an author on the study. "The very high
accuracy of the cancer signal origin prediction for prostate cancer
indicates the need for a prompt diagnostic work-up in those with a
cancer signal detected."
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. GRAIL, LLC, is a subsidiary of
Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina
Inc. under the terms of the Interim Measures Order of the European
Commission.
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
GRAIL's 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. GRAIL's 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 future tests or products,
technology, clinical studies, 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 Registration Statement on Form 10
filed by GRAIL (the "Form 10"), as may be further amended.
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
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may make.
Forward-looking statements relate to the future and,
accordingly, are subject to inherent uncertainties, risks, and
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which are outside of our control. Although we believe the
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Our actual results and financial condition may differ materially
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press release to conform our prior statements to actual results or
revised expectations or to reflect new information or the
occurrence of unanticipated events.
This press release shall not constitute an offer of any
securities for sale, nor shall there be any offer, sale or
distribution of securities in any jurisdiction in which such offer,
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References
- "Initial Treatment of Prostate Cancer, by Stage and Risk
Group." American Cancer Society, 22 Nov.
2023,
www.cancer.org/cancer/types/prostate-cancer/treating/by-stage.html.
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