/U P D A T E -- GRAIL, Inc./
GRAIL (Nasdaq: GRAL) reported PATHFINDER 2 results showing the Galleri® multi-cancer early detection blood test substantially increased cancer detection when added to USPSTF A and B screenings.
In a 35,878-enrolled study (25,578 with ≥12 months follow-up; 23,161 analyzable for performance), adding Galleri produced a >7-fold increase in cancers found within a year versus recommended screenings alone. Galleri detected 216 cancer signals (0.93%) with 133 confirmed cancers (0.57%) and a PPV of 61.6%. Episode sensitivity was 73.7% for 12 high‑mortality cancers and 40.4% for all cancers; specificity was 99.6%. More than half (53.5%) of Galleri‑detected new cancers were stage I–II; Cancer Signal Origin accuracy was 92%.
GRAIL (Nasdaq: GRAL) ha riportato i risultati PATHFINDER 2 che mostrano che il test di rilevamento precoce di cancro multi-cancro Galleri® aggiunto ai screening USPSTF A e B aumenta sostanzialmente la rilevazione dei tumori.
In uno studio con 35.878 partecipanti (25.578 con ≥ 12 mesi di follow-up; 23.161 analizzabili per le prestazioni), aggiungere Galleri ha prodotto un incremento di >7 volte nelle diagnosi di cancro entro un anno rispetto agli screening raccomandati da soli. Galleri ha rilevato 216 segnali di cancro (0,93%) con 133 cancri confermati (0,57%) e una PPV di 61,6%. La sensibilità dell’episodio era 73,7% per 12 tumori ad alta mortalità e 40,4% per tutti i tumori; la specificità era 99,6%. Più della metà (53,5%) dei nuovi tumori rilevati da Galleri erano di stadio I–II; l’accuratezza dell’Origine del Segnale Cancro era 92%.
GRAIL (Nasdaq: GRAL) informó los resultados de PATHFINDER 2 que muestran que la prueba de sangre Galleri® para detección temprana de múltiples tipos de cáncer aumentó sustancialmente la detección de cáncer cuando se añadió a los cribados USPSTF A y B.
En un estudio con 35.878 inscritos (25.578 con ≥ 12 meses de seguimiento; 23.161 analizados para rendimiento), añadir Galleri produjo un aumento de >7 veces en los cánceres detectados dentro de un año frente a los cribados recomendados por sí solos. Galleri detectó 216 señales de cáncer (0,93%) con 133 cánceres confirmados (0,57%) y una PPV de 61,6%. La sensibilidad del episodio fue 73,7% para 12 cánceres de alta mortalidad y 40,4% para todos los cánceres; la especificidad fue 99,6%. Más de la mitad (53,5%) de los nuevos cánceres detectados por Galleri eran estadio I–II; la precisión del Origen de la Señal de Cáncer fue 92%.
GRAIL (나스닥: GRAL)는 PATHFINDER 2 결과를 발표했으며 Galleri® 다중 암 조기 발견 혈액 검사가 USPSTF A 및 B 선별에 추가되었을 때 암 탐지율을 상당히 증가시켰습니다.
참가자 35,878명(≥12개월 추적관찰 25,578명; 성능 분석 가능한 23,161명)에서 Galleri를 추가하면 1년 내 암 발견이 권고 선별만 사용했을 때보다 >7배 증가했습니다. Galleri는 216개의 암 신호(0.93%)를 탐지했고 133개의 확인된 암(0.57%) 및 PPV 61.6%를 보였습니다. 사건 민감도는 고사망률 암 12종에서 73.7%, 모든 암에서 40.4%였으며 특이도는 99.6%였습니다. Galleri에 의해 새로 탐지된 암의 절반 이상(53.5%)이 병기 I–II였고 Cancer Signal Origin의 정확도는 92%였습니다.
GRAIL (Nasdaq : GRAL) a communiqué les résultats PATHFINDER 2 montrant que le test sanguin Galleri® de détection précoce multi-cancers augmente substantiellement la détection du cancer lorsqu'il est ajouté aux dépistages USPSTF A et B.
Dans une étude de 35 878 participants (25 578 avec ≥ 12 mois de suivi; 23 161 analytiques pour la performance), l'ajout de Galleri a produit une augmentation de >7 fois des cancers détectés dans l'année par rapport aux dépistages recommandés seuls. Galleri a détecté 216 signaux de cancer (0,93%) avec 133 cancers confirmés (0,57%) et une VPP de 61,6%. La sensibilité de l'épisode était 73,7% pour 12 cancers à haute mortalité et 40,4% pour tous les cancers; la spécificité était 99,6%. Plus de la moitié (53,5%) des nouveaux cancers détectés par Galleri étaient au stade I–II; l'exactitude de l'Origine du Signal Cancéreux était 92%.
GRAIL (Nasdaq: GRAL) berichtete PATHFINDER 2-Ergebnisse, die zeigen, dass der Galleri®-Bluttest zur Multi-Krebs-Früherkennung die Krebsdetektion deutlich erhöht, wenn er zu USPSTF A- und B-Screenings hinzugefügt wird.
In einer Studie mit 35.878 eingeschriebenen Teilnehmern (25.578 mit ≥ 12 Monaten Follow-up; 23.161 analytisch für die Leistungskennzahlen) führte das Hinzufügen von Galleri zu einer >7-fachen Steigerung der im ersten Jahr gefundenen Krebsfälle im Vergleich zu den empfohlenen Screenings alleine. Galleri dros 216 Krebs-Signale (0,93%) mit 133 bestätigten Krebsfällen (0,57%) und einer PPV von 61,6%. Die Episoden-Sensitivität betrug 73,7% für 12 Krebsarten mit hoher Mortalität und 40,4% für alle Krebsarten; die Spezifität betrug 99,6%. Mehr als die Hälfte (53,5%) der von Galleri entdeckten neuen Krebse waren Stadium I–II; Die Genauigkeit der Krebs-Signal-Ursache betrug 92%.
GRAIL (ناسداك: GRAL) أعلنت عن نتائج PATHFINDER 2 التي أظهرت أن اختبار Galleri® الدموي للكشف المبكر عن عدة أنواع من السرطان يزيد بشكل كبير من اكتشاف السرطان عند إضافته إلى فحص USPSTF من الفئة A والفئة B.
في دراسة شملت 35,878 مشاركاً (25,578 بمتابعة ٪12 شهرًا؛ 23,161 قابل للتحليل للأداء)، أدى إضافة Galleri إلى زيادة >7 أضعاف في اكتشاف السرطان خلال عام مقارنة بالفحوصات الموصى بها وحدها. اكتشف Galleri 216 إشارة سرطان (0.93%) مع 133 سرطانًا مؤكدًا (0.57%) و PPV قدره 61.6%. كانت حساسية الحلقة 73.7% لـ12 سرطاناً عالي الوفيات و40.4% لجميع السرطانات؛ وكانت الخصوصية 99.6%. أكثر من نصف (53.5%) من السرطانات الجديدة التي اكتشفها Galleri كانت في المراحل I–II؛ ودقة أصل إشارة السرطان كانت 92%.
GRAIL (纳斯达克：GRAL) 报告了 PATHFINDER 2 的结果，显示 Galleri® 多发癌早期血液检测在加入 USPSTF A 与 B 筛查后显著提高了癌症检测率。
在一项有 35,878 名参与者的研究中（≥12 个月随访的有 25,578 名；用于性能分析的有 23,161 名），加入 Galleri 导致一年内发现的癌症数量相对于单独推荐筛查增加了 >7 倍。Galleri 检测到 216 个癌症信号（0.93%），其中确认癌症 133 例（0.57%），PPV 为 61.6%。情节敏感性为对 12 种高死亡率癌症 73.7%，对所有癌症为 40.4%；特异性为 99.6%。Galleri 发现的新癌症中超过一半（53.5%）为 I–II 期；癌症信号来源的准确性为 92%。
- Study size: 35,878 enrolled participants
- >7-fold increase in cancers found within one year
- Positive predictive value of 61.6%
- Episode sensitivity 73.7% for 12 high‑mortality cancers
- Specificity 99.6% (false positive rate 0.4%)
- 53.5% of Galleri‑detected cancers were stage I–II
- Cancer Signal Origin accuracy 92%
- Overall episode sensitivity 40.4% for all cancers
- Cancer signal detected in 0.93% of participants
- Confirmed cancer rate 0.57% of participants
- Only 0.6% of participants underwent invasive procedures
Insights
PATHFINDER 2 shows adding Galleri to standard screening materially increased cancer detection and supports a PMA submission timeline.
The data show that adding Galleri to USPSTF A and B screenings produced a more than seven-fold increase in cancers found within 12 months and a
Dependencies and risks remain regulatory and operational: the company will submit PATHFINDER 2 data to the FDA as part of a PMA filing and plans a bridging analysis to align versions, with completion expected in the
In the news release, GRAIL PATHFINDER 2 Results Show Galleri ® Multi-Cancer Early Detection Blood Test Increased Cancer Detection More Than Seven-Fold When Added to USPSTF A and B Recommended Screenings, issued 17-Oct-2025 by GRAIL, Inc. over PR Newswire, we are advised by the company that updated media assets have been attached to the news release. The complete, updated release follows:
GRAIL PATHFINDER 2 Results Show Galleri ® Multi-Cancer Early Detection Blood Test Increased Cancer Detection More Than Seven-Fold When Added to USPSTF A and B Recommended Screenings
More Than Half of Cancers Detected by Galleri Were Early Stage
Approximately Three-Quarters of Galleri-Detected Cancers Do Not Have Recommended Screenings
PATHFINDER 2 is the Largest
PATHFINDER 2 evaluated the safety and performance of the Galleri® multi-cancer early detection (MCED) test when used alongside standard-of-care cancer screenings. The largest interventional study of an MCED test in
"Cancer is the second leading cause of death worldwide as most deadly cancers are found too late. Adding Galleri to recommended screening for breast, cervical, colorectal, and lung cancers in PATHFINDER 2 yielded a more than seven-fold increase in the cancer detection rate, and more than half of the Galleri detected new cancers were found in early stages, when cancers are more treatable and potentially even curable. Galleri's ability to accurately predict where in the body the cancer signal comes from also helps to guide a more efficient diagnostic workup," said Josh Ofman, MD, MSHS, President at GRAIL. "These results are extremely compelling as approximately three-quarters of the Galleri-detected cancers do not have recommended screening tests today. Galleri is the only MCED test available that has been validated in an interventional trial in the screening population and could transform how we deliver cancer screening at a population level."
Finding More Cancers, Earlier By Adding the Galleri Test
Data from the performance analyzable cohort of 23,161 participants with 12 months of follow-up found that adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a more than seven-fold increase in the number of cancers found within a year. Galleri detected approximately three times as many cancers when added to standard-of-care screening for breast, cervical, colorectal, lung, and prostate cancers (USPSTF A, B, and C recommendations). Approximately three-quarters of the cancers detected by Galleri do not have standard of care screening options.
More than half (
"Cancer screening saves lives, but we routinely screen for just four or five cancer types in
High Performance and Low Risk of False Alarms
The Galleri test detected a cancer signal in 216 participants (cancer signal detection rate of
Since PATHFINDER 2 is a prospective clinical trial where the cancer status of participants is unknown at the outset, episode sensitivity – the ability to detect cancer that could be confirmed within 12 months after the blood draw – is a performance measure of the study. Galleri demonstrated strong performance, with
"Any multi-cancer early detection test used for population screening should aim to detect as many aggressive cancers as possible before symptoms arise and maximize the likelihood that a positive test result is actually cancer. The PATHFINDER 2 results demonstrate that the Galleri test is doing just that, increasing the number of cancers detected more than seven-fold when added to recommended screening for breast, cervical, colorectal, and lung cancers, and with a very low false positive rate," said Ofman. "What's especially promising is that Galleri showed strong sensitivity at detecting many of the cancers responsible for the majority of cancer deaths, which we believe provides clinicians with a clinically valuable and validated screening tool."
High Accuracy of Cancer Signal Origin Enabled Efficient Diagnostic Evaluation
A key benefit of Galleri is its ability to predict where in the body the cancer is coming from. The PATHFINDER 2 study demonstrated that the test correctly identified the Cancer Signal Origin (CSO)
MCED test safety was evaluated in an analyzable cohort of 25,114 participants. No serious, study-related adverse events were reported during the diagnostic workup.
Data from this study will be submitted to the
Conference call and webcast with the investment community
GRAIL management will host a conference call and webcast on Oct. 20 at 5 a.m. PT / 8 a.m. ET to discuss results of the PATHFINDER 2 study. A link to the live webcast and recorded replay will be available at the investor relations section of GRAIL's website at investors.grail.com.
Please register for the live event at this link.
To ensure timely connection, please register for the teleconference and join the webcast at least ten minutes before the scheduled start of the call. The live webcast and recorded replay are open to all interested parties.
About the PATHFINDER 2 Study (NCT05155605)
PATHFINDER 2 is a prospective, multi-center, interventional study evaluating the safety and performance of Galleri in approximately 35,000 individuals aged 50 years and older who are eligible for guideline-recommended cancer screening in
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, Galleri can detect more than 50 types of cancer before symptoms appear — when they can be easier to treat and are potentially curable2. Galleri is the only available MCED test with demonstrated performance in patients screened for cancer2,*. The Galleri test increases the number of cancers detected seven-fold when added to recommended screening for breast, cervical, colorectal and lung cancers, and has the lowest false positive rate of any MCED test on the market1,2,3,4,**. When a cancer signal is found, Galleri provides a cancer signal of origin with high accuracy to help guide an efficient diagnostic work-up4,5,6. 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.
* The Galleri test performance metrics were derived from the outcomes of an interventional clinical study of patients presenting for screening without clinical suspicion of cancer, a study population that reflects the intended use population.
** Test performance metrics do not represent results of a head-to-head comparative study. Separate studies have different designs, objectives, and participant populations, which limits the ability to draw conclusions about comparative performance.
Important Galleri Safety Information
The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those age 50 or older. The test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. The Galleri test is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of the test 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 GRAIL, Inc. (the "Company"), include the benefits and use of the Galleri test, the potential of the Galleri MCED test, expectations regarding the final results of the PATHFINDER 2 study, upcoming events and presentations, the timeline and results of a bridging analysis to the FDA, the applicability of the PATHFINDER 2 results to the commercial or FDA versions of the Galleri test, and the timeline for completion of the PMA modular submission.
These statements are only predictions based on the Company's current expectations and projections about future events and trends. There are important factors that could cause 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 and numerous associated risks discussed under the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the period ended December 31, 2024 and Quarterly Reports on Form 10-Q for the periods ended March 31, 2025 and June 30, 2025. Moreover, the Company operates in a dynamic and rapidly changing environment. New risks emerge from time to time. It is not possible for the Company's management to predict all risks, nor can the Company assess the impact of all factors on its 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.
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 the Company's control. Although the Company believes the expectations and projections expressed or implied by the forward-looking statements are reasonable, it cannot guarantee future results, level of activity, performance, or achievements. Actual results and financial condition may differ materially from those indicated in the forward-looking statements. Except to the extent required by law, the Company undertakes no obligation to update any of these forward-looking statements after the date of this press release to conform prior statements to actual results or revised expectations or to reflect new information or the occurrence of unanticipated events.
References:
- Nabavizadeh N, et al. Safety and Performance of a Multi-Cancer Early Detection (MCED) Test in an Intended-Use Population: Initial Results from the Registrational PATHFINDER 2 Study. Proffered Presentation Presented at: European Society for Medical Oncology (ESMO) Annual Meeting; October 17-21, 2025;
Berlin, Germany . - Klein EA, Richards D, Cohn A, et al. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-77. doi: 10.1016/j.annonc.2021.05.806
- GRAIL, Inc. False positive rate. [Data on file: GR-2025-0256]
- Schrag D, Beer TM, McDonnell CH, et al. Blood-based tests for multi-cancer early detection (PATHFINDER): a prospective cohort study. Lancet. 2023;402:1251-1260. doi: 10.1016/S0140-6736(23)01700-2
- GRAIL, Inc. Enhanced Cancer Signal Origin prediction. [Data on file: VV-TMF-59592]
- Hackshaw A, et al. Cancer Cell. 2022;40(2):109-13.
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FAQ
What did GRAIL announce about PATHFINDER 2 results for Galleri (GRAL) on Oct 17, 2025?
How large was the PATHFINDER 2 study included in GRAIL's Oct 17, 2025 release?
What were Galleri's performance metrics reported in PATHFINDER 2 (GRAL)?
What portion of Galleri‑detected cancers were early stage in PATHFINDER 2?
Will GRAIL submit PATHFINDER 2 data to the FDA and when is PMA expected?
How quickly did diagnostic workups resolve after a positive Galleri result in PATHFINDER 2?
