Analysis of Patient Reported Outcomes From
PATHFINDER Indicate Minimal Patient Distress Associated with
Multi-Cancer Early Detection Testing
MENLO
PARK, Calif., Jan. 13,
2025 /PRNewswire/ -- GRAIL, Inc. (Nasdaq: GRAL) a
healthcare company whose mission is to detect cancer early when it
can be cured, today announced that patient-reported outcomes (PRO)
assessing patient perspectives from the PATHFINDER study were
published in Lancet Oncology. The PATHFINDER study included
secondary and exploratory outcomes with the objective of assessing
PRO and perceptions of multi-cancer early detection (MCED)
testing.
PRO assessment was conducted for eligible PATHFINDER study
participants with either a cancer signal detected (CSD) or no
cancer signal detected (NCSD) over a 12-month follow-up period. In
the PATHFINDER study, general anxiety, distress and uncertainty
after results disclosure, health-related quality of life,
satisfaction with the Galleri® test, and intent towards
guideline-recommended screening and repeat MCED testing were
assessed. Three instruments used to assess PRO included an
adapted Multidimensional Impact of Cancer Risk Assessment (MICRA)
for distress, uncertainty and positive experience at MCED test
result disclosure, PRO Measurement Information System (PROMIS)
Anxiety short-form for anxiety symptoms, the Short Form 12-Item
Health Survey (SF-12v2) for health-related quality of life, and a
satisfaction questionnaire.
"Previous studies have shown that there is a temporary increase
in anxiety symptoms after cancer screening, particularly for those
with a test result indicating they may have cancer," said
Lincoln Nadauld, MD, lead author of
the study and was vice president, chief of Precision Health &
Academics at Intermountain Health during the PATHFINDER study and
currently CEO at Culmination Bio, Inc. "PRO results in the
PATHFINDER study were consistent with other studies and showed the
transient nature of the anxiety increase coupled with satisfaction
with the screening and commitment to continue their standard
screenings along with MCED testing. These encouraging results
indicate that MCED could be a valuable tool for early detection
with minimal distress for patients."
Overall the study demonstrated minimal patient distress
associated with MCED testing. Most participants with a NCSD result
responded that they were "relieved about my test result." The
negative patient-reported impacts associated with a CSD test result
were small and returned to baseline within 12 months. High overall
satisfaction with the MCED test was reported across participant
groups regardless of signal detection status and eventual
diagnosis. Most participants reported they were "likely"/"very
likely" to adhere to future guideline recommended screening tests
as recommended by their healthcare provider.
"As the pioneer in multi-cancer early detection, GRAIL is
committed to not only evaluating the performance of the Galleri
test but also the impact of MCED screening on patients," said
Eric Klein, MD, Distinguished
Scientist at GRAIL and co-author on the study. "Collecting
participant perspectives and appropriately supporting recipients of
cancer screening may improve adherence rates and early detection.
The patient-reported outcome findings from the PATHFINDER study
suggest MCED testing is associated with a high level of
satisfaction."
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.
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 extrapolation of data, expectations and projections of
performance and impact of future tests or products, technology,
clinical studies, regulatory compliance, future investment and
strategy and anticipated trends in our business.
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.
