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2ms
GRAIL Presents New Data on Galleri and Its Methylation Platform at the Annual American Association for Cancer Research (AACR) Meeting (Businesswire)
"GRAIL, LLC...will present new data on the clinical utility of its Methylation Platform across the cancer continuum, and the impact of multi-cancer early detection (MCED) testing in guiding diagnostic evaluation at the American Association for Cancer Research (AACR) Annual Meeting in San Diego, Calif., April 5-10, 2024....Demonstrating the first real-world evaluation of repeat MCED / Galleri testing showing the potential value of adding repeat MCED screening. The timeframe for repeat testing occurred 10-18 months from initial MCED testing. Exhibiting 4-year overall survival follow-up demonstrating the prognostic significance of detecting cancer with a methylation-based cfDNA platform like Galleri."
Real-world evidence • Clinical data
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Galleri Test
3ms
A blood-based multi-omics test for multicancer early detection: Combined retrospective and prospective studies (AACR 2024)
The performances of SeekInCare in both retrospective and prospective studies demonstrate that SeekInCare is an effective blood-based MCED test with similar performance as Grail's Galleri test, which paves the way for clinical utility as a cancer screening test in average-risk populations.
Retrospective data
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Galleri Test • SeekInCare™
3ms
Getlabs to add GRAIL's Galleri multi-cancer early detection test to suite of at-home diagnostic services (PRNewswire)
"Getlabs...announced that it will be adding GRAIL's Galleri multi-cancer early detection test to its list of test offerings. Getlabs will facilitate the sample collection process for the Galleri test by bringing the convenience of at-home blood draws to patients, eliminating the need for visits to clinics and reducing barriers to testing."
Licensing / partnership
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Galleri Test
4ms
Curative Insurance Company adds GRAIL’s Galleri® Test to member benefits for multi-cancer early detection (Businesswire)
"Curative Insurance Company...and GRAIL...announced the availability of Galleri®, a multi-cancer early detection (MCED) screening test to eligible insurance plan members. The Galleri test will be available to all members, across all plan types, who are over the age of 50 and to all other members with risk factors for developing cancer. The Galleri test is part of the expansive list of benefit offerings available for $0 copay and $0 deductible* on Curative's health insurance plan."
Clinical
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Galleri Test
5ms
BeniComp to offer GRAIL’s multi-cancer early detection test for employee health screening (Grail Press Release)
"GRAIL, LLC...and BeniComp...announced the availability of Galleri®, a multi-cancer early detection (MCED) screening test, to eligible patients initially through BeniComp Select members. This partnership underscores BeniComp’s commitment to proactive and preventive health management, enabling an even broader reach of their transformative health insurance products."
Licensing / partnership
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Galleri Test
6ms
GRAIL to initiate REACH study to evaluate clinical impact of Galleri® Multi-Cancer Early Detection (MCED) test among the Medicare population (Grail Press Release)
"GRAIL, LLC...announced that it will initiate Real-world Evidence to Advance Multi-Cancer Early Detection Health Equity (REACH/Galleri-Medicare study) following the U.S. Food and Drug Administration’s (FDA) approval of GRAIL’s Investigational Device Exemption (IDE) application and the Centers for Medicare and Medicaid Services’ (CMS) approval for Medicare coverage of the study. With age being the most significant risk factor for cancer, Medicare beneficiaries face the highest unmet need for early cancer detection."
Medicare • Real-world evidence • Reimbursement • New trial
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Galleri Test
7ms
Circulating tumor DNA (ctDNA): can it be used as a pan-cancer early detection test? (PubMed, Crit Rev Clin Lab Sci)
"To demonstrate clinical utility in an asymptomatic population, these tests must be shown to reduce cancer mortality without causing excessive overdiagnosis in a large randomized prospective randomized trial. Such trials are currently ongoing for Galleri and CancerSEEK."
Journal • Review • Pan tumor • Circulating tumor DNA
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CancerSEEK • Galleri Test
7ms
Detection and quantification of triple-negative breast cancer (TNBC) across ethnicities through analysis of cell-free DNA (cfDNA) methylation (SABCS 2023)
In this pilot study, we observed that MCED testing was effective in detecting Stage II, III, and IV TNBC across SRE. These findings, in combination with the association of estimated ctDNA abundance with cancer stage but not patient SRE, provide hypothesis-generating evidence that analysis of methylation signals from across the genome can provide meaningful TNBC screening/detection information, independent of self-reported race/ethnicity. Table 1.
Cell-free DNA
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Galleri Test
7ms
Multi-Cancer Early Detection Test Is Sensitive and Accurate in Detecting Shared DNA Methylation Signal in a Variety of Lymphoid and Plasma Cell Neoplasms (ASH 2023)
Findings from two large validation studies and RWE demonstrate that Galleri promises to be a state of the art molecular tool that detects a shared cancer signal and is able to identify a large variety of histopathologic entities of lymphoid and plasmacytic origin, which currently have no other standard of care screening regimen. This tool may lead to better treatment outcomes and decreased mortality saving lives through the early detection of these previously unscreened cancers.
Epigenetic controller
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Galleri Test
7ms
HCA Healthcare and GRAIL collaborate to advance comprehensive cancer care with multi-cancer early detection screening (Grail Press Release)
"...Sarah Cannon Cancer Institute, part of HCA Healthcare, and GRAIL, LLC...announced a strategic collaboration to advance comprehensive cancer care through early detection...GRAIL’s Galleri® multi-cancer early detection (MCED) test will be available to patients who meet screening criteria at select HCA Healthcare physician practices."
Licensing / partnership
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Galleri Test
8ms
Final results from PATHFINDER study of GRAIL’s multi-cancer early detection blood test published in The Lancet (Grail Press Release)
"GRAIL, LLC...announced that detailed findings from the PATHFINDER study of its multi-cancer early detection (MCED) blood test have been published in The Lancet. The study, conducted in 6,662 adults over the age of 50 without symptoms suggestive of cancer, demonstrated that an earlier version of GRAIL’s MCED test identified many cancer types that do not currently have recommended screening tests, enabled targeted cancer diagnostic evaluations, and supported diagnostic resolution for the majority of participants in less than three months."
Clinical data
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Galleri Test
8ms
Point32Health and GRAIL expand pilot to access Galleri® multi-cancer early detection blood test (Grail Press Release)
"Point32Health...GRAIL...announced the expansion of their pilot to offer GRAIL’s groundbreaking Galleri® multi-cancer early detection screening test. The pilot includes members meeting eligibility requirements whose primary care provider (PCP) is a Mass General Brigham affiliated provider and who are covered under a Harvard Pilgrim Health Care or Tufts Health Plan employer-sponsored plan or a Harvard Pilgrim Health Care Massachusetts Connector plan."
Licensing / partnership
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Galleri Test
9ms
Whitman-Walker Institute, Cancer Support Community and GRAIL collaborate on research aimed at advancing health equity in cancer screening and care through multi-cancer early detection (Grail Press Release)
"Whitman-Walker Institute...Cancer Support Community (CSC)...and GRAIL, LLC...announced a research collaboration aimed at advancing health equity in cancer screening and care with GalleriⓇ, a multi-cancer early detection (MCED) test, in diverse patient populations...The Implementation and Navigation of Cancer Liquid biopsy to Understand Diverse Patient Experiences (INCLUDE) study will evaluate established community outreach strategies intended to build awareness and increase early cancer screening."
Licensing / partnership
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Galleri Test
10ms
Psychological Impact of the Galleri test (sIG(n)al): protocol for a longitudinal evaluation of the psychological impact of receiving a cancer signal in the NHS-Galleri trial. (PubMed)
P=N/A; A separate consent form will be required for interview. Results will be disseminated via peer-reviewed publication and conference presentations.
Journal
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Galleri Test
12ms
GRAIL presents real-world experience with the Galleri® multi-cancer early detection test at 2023 ASCO Annual Meeting (Grail Press Release)
"GRAIL, LLC...announced data evaluating the Galleri® multi-cancer early detection (MCED) test’s ability to detect a cancer signal and predict the cancer signal origin (CSO) in asymptomatic individuals in the real-world setting...Positive Galleri results with a CSO prediction were associated with a diagnosis of invasive cancer across multiple cancer types, including stage I and II cancers. The findings were presented during a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting."
Real-world evidence
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Galleri Test
12ms
New PATHFINDER study analysis demonstrates efficient diagnostic resolution following multi-cancer early detection testing (Grail Press Release)
"GRAIL, LLC...announced results from a retrospective analysis of the interventional PATHFINDER study to assess whether diagnostic evaluations of individuals who received a cancer signal detected (CSD) result with the Galleri® multi-cancer early detection (MCED) test were appropriately directed by the test’s cancer signal origin (CSO) predictions. The findings demonstrated that in the majority of cases (78%), the test’s CSO-directed initial diagnostic evaluation led to a diagnostic resolution. The findings were presented during a poster discussion session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting."
Retrospective data
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Galleri Test
1year
Grail to present new multi-cancer early detection data at the 2023 ASCO Annual Meeting (Grail Press Release)
"GRAIL, LLC...will present new data evaluating the use and potential of its methylation-based multi-cancer early detection (MCED) platform at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 2-6. Presentations include interim results from SYMPLIFY, the first large-scale prospective study to evaluate GRAIL’s MCED test in symptomatic patients referred for cancer suspicion, as well as Galleri® real-world clinical surveillance data and subset analyses from the PATHFINDER clinical implementation study. An evaluation of Galleri implementation using a centralized model within Mercy’s multi-state health system will also be presented."
Real-world evidence • Observational data
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Galleri Test
1year
Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combin (clinicaltrials.gov)
P=N/A; Not yet recruiting --> Recruiting | Initiation date: Oct 2023 --> May 2023
Enrollment open • Trial initiation date • Pan tumor
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Galleri Test
1year
Multi-cancer early detection screening tools: A dream come true or a nightmare in the offing. (ASCO 2023)
In sum, Galleri, as a population-based cancer screening test, is not economically affordable, not ethically equitable, and only marginally medically beneficial.
Galleri Test
1year
Early real-world (RW) experience with a multi-cancer early detection (MCED) test. (ASCO 2023)
RW experience with the MCED test was consistent with previous large-scale clinical studies with an average CSDR of 1.0%, which increased with age. The test detected a CS and predicted CSO across multiple cancers, including early-stage cancers and cancers w/o recommended screening. This indicates that the MCED test can reliably detect a CS, which is essential to support population screening.
Real-world evidence • Clinical • Real-world
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Galleri Test
1year
Implementation of a multi-cancer early detection (MCED) test using a centralized model within (w/i) a multi-state health system. (ASCO 2023)
This model allowed for efficient time to diagnosis and tx or triage of eligible-risk pts using an MCED test and is an example of how a healthcare system can incorporate and scale the implementation of the MCED test into clinical practice.
Galleri Test
1year
FirstHealth of the Carolinas to offer GRAIL’s Galleri®, a multi-cancer early detection blood test (Grail Press Release)
"FirstHealth of the Carolinas, Inc...and GRAIL, LLC...announced the availability of Galleri®, a multi-cancer early detection (MCED) screening test to eligible patients initially through FirstHealth’s Concierge Medicine Clinic in Southern Pines. FirstHealth will be the first health system in North Carolina to offer the Galleri MCED test to those at an elevated risk of cancer, including those aged 50 or older, as part of its comprehensive cancer screening and care. Additional primary care clinics will offer the test in the coming months."
Licensing / partnership
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Galleri Test
1year
GRAIL showcases methylation platform performance across cancer continuum with new data at American Association for Cancer Research (AACR) Annual Meeting (Grail Press Release)
"GRAIL, LLC...will present new data showcasing the performance of its methylation platform to detect cancer across the early- and post-diagnosis settings at the American Association for Cancer Research (AACR) Annual Meeting in Orlando, April 14-19, 2023."
Clinical data
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Galleri Test
1year
Trial initiation date • Pan tumor
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Galleri Test
1year
Providence and GRAIL Expand Partnership to Increase Access to Galleri Multi-Cancer Early Detection Screening (Businesswire)
"Providence...and GRAIL, LLC...today announced the expansion of their partnership to offer multi-cancer early detection screening as part of clinical care to eligible individuals across the entire Providence health system....Through the partnership, eligible patients at Providence’s 52 hospitals and 900 clinics across seven states will have access to GRAIL’s Galleri® multi-cancer early detection (MCED) test, as part of a comprehensive range of health services."
Licensing / partnership
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Galleri Test
over1year
John Hancock expands access to Galleri®, GRAIL’s breakthrough cancer screening technology (Grail Press Release)
"John Hancock, a unit of Manulife (NYSE: MFC), announced it will expand access to GRAIL’s Galleri® multi-cancer early detection test to eligible life insurance customers participating in the John Hancock Vitality PLUS program, a significant milestone in John Hancock’s ongoing efforts to help customers live longer, healthier, better lives. The expanded access comes after John Hancock became the first life insurance carrier to make the breakthrough screening technology available to a pilot group of customers in September 2022."
Clinical
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Galleri Test
over1year
Galleri Test: FDA Final submission in 2024/25 (Illumina)
J.P. Morgan 41st Annual Healthcare Conference Presentation
FDA event
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Galleri Test
over1year
Galleri Test: Planned launch in 2023 (Illumina)
J.P. Morgan 41st Annual Healthcare Conference Presentation
Launch
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Galleri Test
over1year
Point32Health and GRAIL expand Galleri® multi-cancer early detection blood test pilot to Harvard Pilgrim Health Care members on the Maine Health Insurance marketplace (Grail Press Release)
"Point32Health...and GRAIL...announced the expansion of their pilot to offer GRAIL’s groundbreaking Galleri® multi-cancer early detection blood test to Harvard Pilgrim members at no cost who purchase their insurance on the Maine Health Insurance Marketplace. This expansion is the second phase of a pilot focused on collecting real-world evidence to assess the impact of the Galleri test on health care resource utilization and patient-reported outcomes."
Real-world evidence
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Galleri Test
over1year
Cost effectiveness of liquid biopsy for colorectal cancer screening. (ASCO-GI 2023)
CRC screening with LB alone or with LB in conjunction with colonoscopy among nonadherent patients is not cost-effective in the US context. At this time, LB is unable to detect pre-cancerous colon polyps, which may limit its effectiveness as a CRC screening strategy. >
HEOR • Cost-effectiveness • Cost effectiveness • Liquid biopsy • Biopsy
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Galleri Test
over1year
GRAIL CCGA discovery results published in Cancer Cell reveal methylation as promising DNA hallmark for multi-cancer early detection (Grail Press Release)
"GRAIL, LLC...announced findings from a fundamental substudy of the Circulating Cell-free Genome Atlas (CCGA; NCT02889978) study, demonstrating that methylation had the most promising combination of cancer detection and prediction of cancer signal origin when compared with other evaluated approaches. This is the first rigorous and systematic comparison of various genomic measures from circulating cell-free DNA (cfDNA) for multi-cancer early detection (MCED) testing, and the largest comprehensive genome-wide comparison of cfDNA approaches. Findings were published online in Cancer Cell in a manuscript titled 'Evaluation of Cell-Free DNA Approaches for Multi-Cancer Early Detection.'"
Clinical data
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Galleri Test
over1year
GRAIL and Carrum Health partner to include Galleri® as part of comprehensive cancer care offering to employers (Grail Press Release)
"GRAIL, LLC...and Carrum Health...today announced a first-of-its-kind partnership to include the Galleri® multi-cancer early detection (MCED) test as part of Carrum Health’s oncology offering to self-insured employers. This product integration will enable employers who offer Carrum Health benefits to provide eligible employees the Galleri test as part of the comprehensive cancer care Carrum delivers."
Licensing / partnership
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Galleri Test
over1year
Henry Ford Health first in Michigan to offer multi-cancer early detection blood test (PRNewswire)
"Henry Ford Health...and GRAIL...today announced Henry Ford Health as the first healthcare provider in Michigan to offer Galleri®, GRAIL's Multi-Cancer Early Detection (MCED) blood test. Henry Ford is among an early group of healthcare providers in the U.S. to offer this MCED test."
Licensing / partnership • Clinical
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Galleri Test
over1year
John Hancock becomes first life insurance carrier to offer access to GRAIL’s multi-cancer early detection test to customers (Grail Press Release)
"John Hancock, the US division of Toronto-based Manulife...announced it is offering access to GRAIL’s Galleri® multi-cancer early detection test to a pilot group of existing customers through the John Hancock Vitality Program, in collaboration with reinsurer Munich Re Life US...Through this pilot, John Hancock will assess customer adoption of Galleri, as well as the overall user experience, before deciding how best to offer the test in the future."
Clinical
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Galleri Test
over1year
GRAIL announces final results from the PATHFINDER multi-cancer early detection screening study at ESMO Congress 2022 (Grail Press Release)
"GRAIL, LLC...announced final results from the interventional PATHFINDER study, which evaluated multi-cancer early detection (MCED) screening using a blood test and the clinical care pathways following a 'cancer signal detected' MCED test result in 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer. Results were presented in a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris."
Clinical data
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Galleri Test
over1year
GRAIL to present final multi-cancer early detection data from the interventional PATHFINDER study at ESMO Congress 2022 (Grail Press Release)
"GRAIL, LLC...announced final results from the interventional PATHFINDER study will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris. PATHFINDER data evaluating the Galleri® multi-cancer early detection (MCED) blood test will be shared in a September 11 proffered paper session."
Clinical data
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Galleri Test
almost2years
Grail and National Health Service (NHS) England complete enrollment of 140,000 participants in largest study of multi-cancer early detection test (Grail Press Release)
"GRAIL, LLC...announced today that the NHS-Galleri trial successfully completed enrollment in just over 10 months. The trial, which is the largest-ever study of a multi-cancer early detection (MCED) test, has enrolled 140,000 healthy volunteers aged 50-77 from select regions throughout England who have not had a cancer diagnosis or undergone treatment for cancer in the last three years."
Enrollment closed • Clinical
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Galleri Test
almost2years
Mercy offers new GRAIL blood test to detect 50+ types of cancer (Grail Press Release)
"Mercy and GRAIL, LLC...announced plans to offer a multi-cancer early detection (MCED) blood test. GRAIL’s Galleri® test uses advanced testing capabilities to detect early cancer signals of more than 50 types of cancer. Mercy is early among health systems to offer this first-of-its-kind test."
Licensing / partnership
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Galleri Test
almost2years
Community Health Network and GRAIL Partner to offer Galleri® multi-cancer early detection test in central Indiana (Grail Press Release)
"Indianapolis-based Community Health Network and GRAIL, LLC...announced a partnership to offer Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test, to individuals at Community Health Network’s sites of care. Community Health Network, central Indiana’s leading integrated healthcare system with more than 200 sites of care, will be the first healthcare system to offer the Galleri test to patients in its area."
Licensing / partnership
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Galleri Test
almost2years
GRAIL and Westminster Fire Department partner to offer Galleri® multi-cancer early detection test to firefighters (Grail Press Release)
"GRAIL...announced today a partnership with the Westminster Fire Department (WFD) in Colorado to provide Galleri®, GRAIL’s groundbreaking multi-cancer early detection (MCED) blood test, to WFD’s firefighters and staff. WFD, which operates six fire stations across Westminster, will be the first fire department in Colorado to offer the Galleri test to its workforce."
Licensing / partnership
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Galleri Test
almost2years
GRAIL and Fountain Health Insurance partner to provide coverage of Galleri® multi-cancer early detection test (Grail Press Release)
"GRAIL, LLC...and Fountain Health Insurance (“Fountain Health”) today announced a partnership that will offer Galleri®, GRAIL’s multi-cancer early detection (MCED) blood test, to Fountain Health customers at 100% coverage as part of its annual wellness benefits."
Licensing / partnership • Reimbursement
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Galleri Test
almost2years
GRAIL and England’s National Health Service (NHS) present trial design for largest study of multi-cancer early detection test at ASCO Annual Meeting (Grail Press Release)
"GRAIL, LLC...announced today that the study design of the NHS-Galleri trial was presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The poster, titled 'NHS-Galleri Trial Design: Equitable Study Recruitment Tactics for Targeted Population-Level Screening With a Multi-Cancer Early Detection (MCED) Test,' was presented...The collaboration between GRAIL and the NHS supports the NHS Long Term Plan to transform cancer care with three in four cancers diagnosed at an early stage by 2028."
New trial
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Galleri Test