Patient Reported Outcomes for GRAIL's Galleri® Multi-Cancer Early Detection Blood Test Published in Lancet Oncology
Analysis of Patient Reported Outcomes From PATHFINDER Indicate Minimal Patient Distress Associated with Multi-Cancer Early Detection 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-
"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
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
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
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
Forward Looking Statements
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GRAIL Contacts: Corporate Communications, Kristen Davis, Trish Rowland, pr@grail.com; Investor Relations, Alex Dobbin, Alexis Tosti, ir@grail.com