Patient Reported Outcomes for GRAIL's Galleri® Multi-Cancer Early Detection Blood Test Published in Lancet Oncology
GRAIL (NASDAQ: GRAL) published patient-reported outcomes (PRO) from their PATHFINDER study in Lancet Oncology, evaluating patient perspectives on their Galleri® multi-cancer early detection (MCED) blood test. The study assessed participants with cancer signal detected (CSD) and no cancer signal detected (NCSD) over 12 months.
Key findings showed minimal patient distress associated with MCED testing. Most participants with NCSD results reported feeling relieved, while those with CSD results experienced only small negative impacts that returned to baseline within 12 months. The study measured anxiety, distress, uncertainty, health-related quality of life, and satisfaction using three assessment instruments.
High overall satisfaction was reported across all participant groups, regardless of signal detection status. Most participants indicated they were likely to continue with both standard screening and MCED testing in the future.
GRAIL (NASDAQ: GRAL) ha pubblicato i risultati degli outcomes riportati dai pazienti (PRO) del loro studio PATHFINDER sulla rivista Lancet Oncology, valutando le prospettive dei pazienti sul test del sangue Galleri® per la rilevazione precoce multi-cancro (MCED). Lo studio ha valutato i partecipanti con segnale di cancro rilevato (CSD) e senza segnale di cancro rilevato (NCSD) per un periodo di 12 mesi.
I risultati principali hanno mostrato minimo disagio per i pazienti associato al test MCED. La maggior parte dei partecipanti con risultati NCSD ha riportato una sensazione di sollievo, mentre coloro che avevano risultati CSD hanno sperimentato solo piccoli impatti negativi che sono tornati ai livelli iniziali entro 12 mesi. Lo studio ha misurato ansia, disagio, incertezza, qualità della vita correlata alla salute e soddisfazione utilizzando tre strumenti di valutazione.
È stata riportata un'alta soddisfazione generale tra tutti i gruppi di partecipanti, indipendentemente dallo stato di rilevamento del segnale. La maggior parte dei partecipanti ha indicato di essere probabilmente inclinati a continuare sia con lo screening standard che con il test MCED in futuro.
GRAIL (NASDAQ: GRAL) publicó los resultados de los resultados reportados por los pacientes (PRO) de su estudio PATHFINDER en Lancet Oncology, evaluando las perspectivas de los pacientes sobre su análisis de sangre Galleri® para la detección temprana de múltiples cánceres (MCED). El estudio evaluó a los participantes con señal de cáncer detectada (CSD) y sin señal de cáncer detectada (NCSD) durante 12 meses.
Los hallazgos clave mostraron mínimo malestar en los pacientes asociado con el análisis MCED. La mayoría de los participantes con resultados NCSD reportaron sentirse aliviados, mientras que aquellos con resultados CSD experimentaron solo pequeños impactos negativos que regresaron a la línea de base en un plazo de 12 meses. El estudio midió ansiedad, malestar, incertidumbre, calidad de vida relacionada con la salud y satisfacción usando tres instrumentos de evaluación.
Se reportó una alta satisfacción general entre todos los grupos de participantes, independientemente del estado de detección de señales. La mayoría de los participantes indicó que era probable que continuaran tanto con el screening estándar como con el análisis MCED en el futuro.
GRAIL (NASDAQ: GRAL)은 Lancet Oncology에 PATHFINDER 연구에서 환자가 보고한 결과(PRO)를 발표하며, Galleri® 다중 암 조기 발견(MCED) 혈액 검사에 대한 환자의 관점을 평가했습니다. 이 연구는 암 신호가 감지된(CSD) 참가자와 암 신호가 감지되지 않은(NCSD) 참가자를 12개월 동안 평가했습니다.
주요 결과는 MCED 검사와 관련하여 환자의 불편함이 최소화되었음을 보여주었습니다. 대부분의 NCSD 결과를 가진 참가자들은 안도감을 느꼈다고 보고했으며, CSD 결과를 가진 사람들은 12개월 이내에 기저선으로 돌아오는 소량의 부정적인 영향을 경험했습니다. 연구는 불안, 고통, 불확실성, 건강 관련 삶의 질 및 만족도를 세 가지 평가 도구를 사용하여 측정했습니다.
모든 참가자 그룹에서 신호 감지 상태에 관계없이 높은 전반적 만족도가 보고되었습니다. 대부분의 참가자들은 앞으로 표준 검진 및 MCED 검사를 계속할 가능성이 높다고 표시했습니다.
GRAIL (NASDAQ: GRAL) a publié les résultats des résultats rapportés par les patients (PRO) de leur étude PATHFINDER dans la revue Lancet Oncology, évaluant les perspectives des patients sur leur test sanguin Galleri® pour la détection précoce de plusieurs cancers (MCED). L'étude a évalué des participants avec un signal de cancer détecté (CSD) et sans signal de cancer détecté (NCSD) sur une période de 12 mois.
Les principaux résultats ont montré un minimum de détresse chez les patients associée au test MCED. La plupart des participants ayant des résultats NCSD ont déclaré se sentir soulagés, tandis que ceux ayant des résultats CSD ont uniquement ressenti de petits impacts négatifs qui sont revenus à la normale sous 12 mois. L'étude a mesuré l'anxiété, la détresse, l'incertitude, la qualité de vie liée à la santé et la satisfaction à l'aide de trois outils d'évaluation.
Une satisfaction générale élevée a été reportée dans tous les groupes de participants, indépendamment de l'état de détection du signal. La plupart des participants ont indiqué qu'ils étaient susceptibles de continuer avec le dépistage standard et le test MCED à l'avenir.
GRAIL (NASDAQ: GRAL) veröffentlichte die patientenberichteten Ergebnisse (PRO) aus ihrer PATHFINDER-Studie in der Lancet Oncology, die die Perspektiven der Patienten zu ihrem Galleri®-Bluttest zur Früherkennung von mehreren Krebsarten (MCED) bewertete. Die Studie untersuchte Teilnehmer mit nachgewiesenem Krebssignal (CSD) und ohne Krebssignal (NCSD) über einen Zeitraum von 12 Monaten.
Die wichtigsten Ergebnisse zeigten minimale Belastung der Patienten im Zusammenhang mit dem MCED-Test. Die meisten Teilnehmer mit NCSD-Ergebnissen berichteten von Erleichterung, während diejenigen mit CSD-Ergebnissen nur kleine negative Auswirkungen erlebten, die innerhalb von 12 Monaten auf das Ausgangsniveau zurückkehrten. Die Studie maß Angst, Belastung, Ungewissheit, gesundheitsbezogene Lebensqualität und Zufriedenheit anhand von drei Bewertungsinstrumenten.
Eine hohe allgemeine Zufriedenheit wurde über alle Teilnehmergruppen hinweg berichtet, unabhängig vom Signalstatus. Die meisten Teilnehmer gaben an, dass sie wahrscheinlich weiterhin sowohl mit dem Standard-Screening als auch mit dem MCED-Test in der Zukunft fortfahren würden.
- High patient satisfaction reported across all participant groups
- Minimal patient distress associated with testing
- Strong patient commitment to continue both standard and MCED screening
- None.
Insights
The publication of PATHFINDER's patient-reported outcomes in Lancet Oncology, a top-tier medical journal, provides critical validation for GRAIL's Galleri® test implementation strategy. The study's findings address a important concern in cancer screening - patient psychological impact - which directly influences adoption rates and commercial success.
The key metrics demonstrate remarkably positive outcomes:
- Minimal distress reported by patients receiving negative results
- Temporary anxiety increases that normalized within 12 months for positive results
- High satisfaction rates across all participant groups
- Strong intent to maintain both standard screening and MCED testing
From a market perspective, these results significantly de-risk the commercial rollout of Galleri®. Patient acceptance and minimal psychological burden are important factors for healthcare providers considering test adoption and insurance companies evaluating coverage. The data suggests GRAIL has effectively addressed a major potential barrier to widespread implementation.
This publication represents a significant milestone in GRAIL's commercial strategy. The positive patient experience data creates a compelling narrative for healthcare systems and insurance providers - key stakeholders in driving widespread adoption. The results effectively address two critical market barriers:
- Patient compliance concerns
- Healthcare provider hesitation about psychological impact
For investors, this validation from a prestigious journal strengthens GRAIL's market position and potential revenue growth trajectory. The $584M market cap company now has robust evidence to support accelerated market penetration, particularly important as early cancer detection becomes increasingly central to healthcare strategies. The demonstrated patient satisfaction and minimal psychological impact could accelerate insurance coverage decisions, potentially leading to broader market access and revenue growth.
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-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
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:
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.
FAQ
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