Latest news with #MCED
Yahoo
02-06-2025
- Business
- Yahoo
ASCO 2025: Harbinger Health reports clinical data of blood-based MCED test
Harbinger Health has reported clinical data at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, US, highlighting the performance of its blood-based multi-cancer early detection (MCED) test. The test, which employs circulating tumour DNA (ctDNA) methylation patterns, shows promise in detecting various high-incidence cancers, especially in populations at elevated risk due to obesity. It is designed to fill the void in early detection for cancers that lack established screening programmes. Harbinger-developed platform integrates insights of the origin of cancer biology with AI and analytical methods to offer diagnostic and screening tools for diverse clinical settings and cancer types. The reflex test system of the company uses a two-tiered approach. The initial methylome profiling test is said to be optimised for high sensitivity to exclude disease, followed by a confirmatory reflex test with a broader methylation panel to enhance positive predictive value (PPV), rule the cancer presence and detect the tissue of origin. The Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) trial, conducted in collaboration with Sarah Cannon Research Institute, enrolled around 8,095 participants from 126 US sites. It included patients diagnosed with various tumour types and a control group without suspected cancer during the enrolment period. The controls were monitored for one year to verify their cancer-free status. Key findings presented include a focus on a test cohort of 762 obese subjects, who were assembled from CORE-HH. The assessment of the test's performance was made across a range of cancer types. At 98.3% specificity, the reflex test showed a sensitivity of 25.8% for early-stage (I-II) cancers and 80.3% for advanced stages (III-IV). For cancers without current screening options, the sensitivity was 50.9%. The colorectal, breast, prostate, cervix, and lung cancer screening programmes for the general population were excluded. The company noted that in a modelled cohort of 100,000 individuals, the test detected 51 of 86 pancreaticobiliary cancers, including eight at an early stage. Harbinger Health chief medical officer Hutan Ashrafian said: 'While the obesity-associated subset demonstrates our ability to target high-risk groups, the broader results underscore the platform's potential across a wide range of deadly cancers that lack mechanisms for effective, large-scale early detection via routine screening.' In 2023, Harbinger Health raised $140m in a Series B funding round for the completion of the CORE-HH study. "ASCO 2025: Harbinger Health reports clinical data of blood-based MCED test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
02-06-2025
- Business
- Yahoo
ASCO 2025: Harbinger Health reports clinical data of blood-based MCED test
Harbinger Health has reported clinical data at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, US, highlighting the performance of its blood-based multi-cancer early detection (MCED) test. The test, which employs circulating tumour DNA (ctDNA) methylation patterns, shows promise in detecting various high-incidence cancers, especially in populations at elevated risk due to obesity. It is designed to fill the void in early detection for cancers that lack established screening programmes. Harbinger-developed platform integrates insights of the origin of cancer biology with AI and analytical methods to offer diagnostic and screening tools for diverse clinical settings and cancer types. The reflex test system of the company uses a two-tiered approach. The initial methylome profiling test is said to be optimised for high sensitivity to exclude disease, followed by a confirmatory reflex test with a broader methylation panel to enhance positive predictive value (PPV), rule the cancer presence and detect the tissue of origin. The Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) trial, conducted in collaboration with Sarah Cannon Research Institute, enrolled around 8,095 participants from 126 US sites. It included patients diagnosed with various tumour types and a control group without suspected cancer during the enrolment period. The controls were monitored for one year to verify their cancer-free status. Key findings presented include a focus on a test cohort of 762 obese subjects, who were assembled from CORE-HH. The assessment of the test's performance was made across a range of cancer types. At 98.3% specificity, the reflex test showed a sensitivity of 25.8% for early-stage (I-II) cancers and 80.3% for advanced stages (III-IV). For cancers without current screening options, the sensitivity was 50.9%. The colorectal, breast, prostate, cervix, and lung cancer screening programmes for the general population were excluded. The company noted that in a modelled cohort of 100,000 individuals, the test detected 51 of 86 pancreaticobiliary cancers, including eight at an early stage. Harbinger Health chief medical officer Hutan Ashrafian said: 'While the obesity-associated subset demonstrates our ability to target high-risk groups, the broader results underscore the platform's potential across a wide range of deadly cancers that lack mechanisms for effective, large-scale early detection via routine screening.' In 2023, Harbinger Health raised $140m in a Series B funding round for the completion of the CORE-HH study. "ASCO 2025: Harbinger Health reports clinical data of blood-based MCED test" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
31-05-2025
- Business
- Yahoo
Harbinger Health Showcases Multi-Cancer Early Detection Performance in High-Risk Populations at ASCO 2025
Reflex blood-based multi-cancer early detection (MCED) test demonstrated clinically meaningful per-cancer Positive Predictive Value (PPV) and early-stage sensitivity for multiple cancers with elevated incidence and mortality in a high-risk population Data to be presented at ASCO's Clinical Science Symposium on the future of cancer detection CAMBRIDGE, Mass., May 31, 2025 (GLOBE NEWSWIRE) -- Harbinger Health, a biotechnology company pioneering the detection of early cancer, today announced clinical data demonstrating the performance of its blood-based MCED test across multiple high-incidence, high-mortality cancers, including those disproportionately affecting individuals with obesity, at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Results highlight the potential of Harbinger's ctDNA-methylation-based assay and reflex testing paradigm to address gaps in population-level early cancer detection, particularly for cancers without established screening programs, and in high-risk patient populations with limited clinical guidelines. 'The results from our study demonstrate the robust early-stage performance of our test across multiple cancer types. While the obesity-associated subset demonstrates our ability to target high-risk groups, the broader results underscore the platform's potential across a wide range of deadly cancers that lack mechanisms for effective, large-scale early detection via routine screening,' said Hutan Ashrafian, M.D., Ph.D., M.B.A., Chief Medical Officer of Harbinger Health. 'The analysis that we are presenting at ASCO validates the alignment between our test performance and disease burden and reflects our commitment to designing a test for those who need it most, when it matters most.' Harbinger's test uses specific proprietary methylation patterns of cell-free ctDNA in blood to detect the presence of cancer. The company has developed a platform that combines unique insights into the biology of cancer's origin with artificial intelligence and analytical and methodological innovations to create novel diagnostic and screening products in multiple clinical settings and cancer indications. Harbinger's reflex test system uses a two-step approach. The primary methylome profiling test is optimized for high sensitivity to rule out disease. This is followed by a confirmatory reflex test with an expanded methylation panel designed to improve PPV, rule in the presence of cancer, and identify tissue of origin (TOO). Harbinger conducted the Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study (NCT05435066) with Sarah Cannon Research Institute to validate and further develop Harbinger's platform. The multi-center, case-controlled study enrolled approximately 8,095 subjects from 126 sites across the U.S. and included two groups: a cancer group of treatment-naïve patients with confirmed diagnoses across 20+ solid and hematologic tumor types, and a non-cancer (control) group of individuals without suspected cancer at enrollment. All participants provided a single blood sample, and controls were followed for one year to confirm their cancer-free status. Dax Kurbegov, M.D., Senior Vice President at HCA Healthcare Sarah Cannon Cancer Network, will present the findings from the obesity cohort of the CORE-HH study at a Clinical Science Symposium entitled 'The Future of Cancer Detection is Coming' from 8:00-9:30 a.m. CDT on Saturday, May 31, 2025, in Hall D1 of the McCormick Place Chicago Convention Center. Key highlights from the presentation include: The test cohort, consisting of 762 individuals with obesity, was assembled from the CORE-HH study and had a mean age of 57.1 ± 13.4 years and were 63.3% female, 22.4% Black or African American, and 67.8% White. The distribution of cancer types evaluated in this study was breast, uterine, lung, lymphoid-line, prostate, colorectal, pancreas, upper GI (includes esophageal, esophagogastric junction, and gastric), head and neck, liver, biliary tract, and others. Cancer types grouped under 'Others' were not used to train the TOO model due to low sample counts. These include ovarian, renal, anal, neuroendocrine, cervical, melanoma, bladder, myeloid, soft tissue, sarcoma, among others. At 98.3% specificity, the reflex test achieved conventional sensitivities of 25.8% for early-stage (I-II) cancer and 80.3% for late-stage (III-IV) cancer. At 98.3% specificity, the reflex test achieved a conventional sensitivity of 50.9% for cancers without a screening program in the U.S. general population. Cancers with screening programs in the U.S. general population that were excluded are breast, colorectal, lung, prostate, and cervix. Overall intrinsic accuracy - the proportion of correct TOO readouts among cases with a corresponding readout category - was 36%. TOO-specific performance as measured by PPV for the following cancers was hepatobiliary (15%), upper GI (22%), colorectal (33%), and lung cancer (25%). In a modeled 100,000-person cohort, the test identified 51 of 86 pancreaticobiliary cancers, including 8 of 31 at early-stage. Dr. Kurbegov commented: 'These data introduce for the first time a metric for intrinsic accuracy to measure a test's ability to correctly identify both a cancer signal and its tissue of origin. This is a more stringent and clinically relevant result as compared to conventional sensitivity, which has been the current industry standard and does not provide information on the location of cancer within an individual. Measuring per-cancer PPV, combined with the reflex test design, are novel aspects of Harbinger's approach that may support stratified diagnostic and follow-up strategies that could help physicians tailor downstream evaluation and management according to the likely tissue of origin and associated benefit-risk considerations. These advances solve some of the most confounding challenges we currently face in our ability to make the most of blood-based tools for early cancer detection. Given these technological advances and study results, I am optimistic that the future of cancer detection is bright and close at hand.' Obesity is estimated to contribute to ~84,000 new cancer cases in the U.S. annually1,2, and the incidence of obesity-related cancers has increased substantially over the past two decades3. Thirteen obesity-associated cancers represent ~40% of cancer diagnoses in the U.S.4, and most of these cancers, such as pancreatic, liver, and endometrial, do not have screening programs available. About Harbinger Health Harbinger Health is leading a transformation in early cancer detection, introducing fundamentally new approaches to screening, diagnosis, and management. The company combines advances in artificial intelligence with proprietary insights into the biology of the beginnings of cancer to identify cancer before it is visible or symptomatic with the aim of developing a low-cost, multi-cancer blood test. Harbinger envisions a future where, instead of keeping cancer from spreading, it could be kept from forming, making a cancer diagnosis a routine health problem to be addressed rather than a life-altering event to be feared with profound implications for people, healthcare systems and societies. Harbinger was founded by Flagship Pioneering after three years of foundational research in its Labs unit and launched in 2020. Learn more about Harbinger by visiting or following us on LinkedIn. Media Contactpress@ ______________________________________ American Association for Cancer Research. Cancer Progress Report 2024 Ligibel JA, Alfano CM, Courneya KS, et al. American Society of Clinical Oncology position statement on obesity and cancer. J Clin Oncol. 2014 Shiels MS, Haque AT, González AB et al. Trends in Cancer Incidence and Mortality Rates in Early-Onset and Older-Onset Age Groups in the United States, 2010–2019. Cancer Discovery. 2025 National Cancer Institute. Obesity and Cancer Fact Sheet. Updated 2022Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Cision Canada
28-05-2025
- Health
- Cision Canada
Geneseeq's Breakthrough Cancer Detection Blood Test Published in Nature Medicine
Large-Scale Study Confirms CanScan ® Test Accurately Detects Early-Stage Cancers From a Simple Blood Draw TORONTO, May 28, 2025 /CNW/ - Geneseeq is proud to announce the publication of results from its large-scale multi-cancer early detection (MCED) study in Nature Medicine, one of the world's leading peer-reviewed medical journals. The publication presents findings from the DECIPHE-Omnia Study (Detecting Early Cancer by Inspecting ctDNA Features), a landmark effort evaluating CanScan ®, Geneseeq's advanced blood-based test for early cancer detection. Innovation Behind CanScan ® CanScan ® is a non-invasive blood test powered by AI-driven whole-genome sequencing. It analyzes subtle cancer-specific changes in circulating cell-free DNA (cfDNA) using Geneseeq's proprietary MERCURY TM Technology. By integrating fragmentomics, genomic, and epigenomic features, the test identifies whether a cancer signal is present and accurately predicts the tissue of origin (TOO). In 2023, CanScan ® received Breakthrough Device Designation from the U.S. FDA. A New Way to Catch Cancer Early Unlike traditional cancer screening tools that are limited to one type of cancer and often involve invasive procedures, CanScan ® offers a convenient, comprehensive solution: a single blood test that screens for more than a dozen cancers at once. In the study: CanScan ® detected early-stage cancers with high accuracy Identified cases missed by routine physical exams Produced a low false-positive rate, helping reduce unnecessary follow-ups "This study brings us closer to making routine multi-cancer screening a reality," said Dr. Yang Shao, CEO of Geneseeq. "Our vision is a future where a simple blood test can help save lives through earlier diagnosis." The Landmark DECIPHER-Omnia Study The DECIPHER-Omnia Study is a multi-phase clinical research program involving more than 8,000 participants to date across three stages: Test development and training using samples from cancer patients and healthy donors Independent clinical validation in a separate cohort A large-scale ongoing screening study in asymptomatic individuals aged 45–75 (the JINLING cohort) The newly published Nature Medicine paper presents interim findings from over 3,700 participants in the JINLING cohort. Key Interim Results: Specificity: 98.1% Sensitivity: 53.5% across all detected cancers; 62.1% for targeted cancer types Early-stage detection: 93% of confirmed cases were Stage 0, I, or II Positive Predictive Value (PPV): 25% — 10 times higher than standard screening (2.2%) Low false positives: Reduced unnecessary follow-up procedures Detection of missed cancers: CanScan ® identified 53.3% of cancers overlooked by standard screening Looking Ahead The JINLING cohort study has now successfully completed enrollment of its target 15,000 participants and is currently in the follow-up and data analysis phase. The complete dataset, along with ongoing monitoring, is expected to provide deeper insights into the real-world utility of CanScan ® for population-level cancer screening. Geneseeq Technology Inc. is a research-driven global leader in precision oncology, pioneering next-generation sequencing (NGS) technologies to transform cancer detection, diagnosis, and treatment. Its portfolio includes comprehensive genomic profiling for all tumor types, cancer-specific panels, minimal residual disease (MRD) monitoring, and multi-cancer early detection (MCED) solutions. Geneseeq has achieved several key regulatory milestones, including CE-IVD certification for its solid tumor and hematologic cancer panels, CE mark and FDA Breakthrough Device Designation for its MCED test, CanScan ®, and NMPA approval for two NGS-based IVD kits in lung cancer, including tumor mutational burden (TMB) detection. With headquarters in Canada and China, Geneseeq operates CAP- and CLIA-certified laboratories and partners with hospitals, research institutions, and pharmaceutical companies worldwide to advance precision medicine.
Business Wire
22-05-2025
- Health
- Business Wire
Exact Sciences Highlights Innovations in Early Cancer Detection and Precision Oncology at ASCO 2025
MADISON, Wis.--(BUSINESS WIRE)--Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced it will present ten abstracts at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30–June 3, 2025, in Chicago, Ill. Presentations include new data on the Oncodetect™ molecular residual disease (MRD) test, multi-cancer early detection (MCED) testing, the Oncotype DX Breast Recurrence Score® test, and the Cologuard® test that underscore Exact Sciences' expanding portfolio and commitment to advancing care through scientific excellence. 'The data Exact Sciences will present at ASCO 2025 reflect the scientific rigor and clinical significance of our expanding portfolio and pipeline,' said Dr. Rick Baehner, MD, chief medical officer, Precision Oncology at Exact Sciences. 'From MRD to MCED to CRC screening, we are advancing evidence-based innovations that help empower providers and deliver crucial answers to patients. Every study, partnership, and data point move us closer to a future where cancer is detected earlier and treated with greater precision.' Real-world evidence supporting the Cologuard test continues to grow, with ongoing research into repeat screening. New data from prominent experts and research groups reinforce the Oncotype DX® test as a trusted, evidence-backed tool, further affirming its role as the standard of care for predicting chemotherapy benefit for breast cancer patients. Building on more than a decade of experience with Cologuard and 20 years of leadership with the Oncotype DX test, Exact Sciences continues to advance the future of precision oncology and multi-cancer screening. New Data and Continuous Evidence Generation Underscore the Oncodetect Test's Power to Detect Cancer Recurrence. Data from the Beta-CORRECT study further strengthens the clinical foundation of the Oncodetect test, confirming its role in helping guide treatment decisions and surveillance strategies for patients with stage II–IV colorectal cancer1. Expanding on this evidence to multiple solid tumor types, Exact Sciences and Flatiron Health continue enrollment in a multi-year, prospective study evaluating how MRD testing can improve cancer monitoring and treatment decisions in community care settings. New Data Support Promise of MCED as Exact Sciences Prepares for LDT Launch. A modeling study found annual MCED testing could reduce late-stage cancer incidence by more than 40% and mortality by up to 18% in high-risk groups2. Additionally, the Falcon registry, a large, prospective real-world study of Exact Sciences' MCED test, will track 25,000 participants against a 50,000-person standard-care cohort to assess adoption, outcomes, and patient experience. These findings come as Exact Sciences prepares to launch Cancerguard™ EX, its MCED lab-developed test (LDT), in the second half of the year, marking a significant step in expanding access to earlier cancer detection. Exact Sciences abstracts at ASCO include: Precision Oncology The Association of Circulating Tumor DNA (ctDNA) with Recurrence in Patients with Stage II-IV Colorectal Cancer: The ꞵ-CORRECT Study Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3590 Molecular Residual Disease (MRD) in Solid Tumors Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: TPS3186 Enhancing Recurrence Detection in Stage III Colorectal Cancer Patients Through Molecular Residual Disease Test-guided Surveillance: A Modeling Study Abstract number: e15600 Patient outcomes in WSG-ADAPT according to NATALEE and MonarchE risk criteria Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 601 Screening Adherence to repeat screening for colorectal cancer using the multi-target stool DNA test: Real-world analysis of patients from Federally Qualified Health Centers Saturday, May 31, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 3630 A decade of progress: Trends in 5-year survival across 17 cancer types Abstract number: e23262 The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: 10542 Falcon – Exact Sciences' multi-cancer early detection (MCED) real-world evidence (RWE) registry Saturday, May 31, 2025, from 1:30 PM to 5:30 PM CT Abstract number: TPS11189 Evaluation of plasma methylated DNA markers for detection HPV-positive oropharyngeal squamous cell carcinoma: a case control study Monday, June 2, 2025, from 9:00 AM to 12:00 PM CT Abstract number: 6057 Feasibility of vaginal tampons versus vaginal swabs in the collection of vaginal fluid for endometrial cancer testing Abstract number: e17617 References Hashimoto et al. The association of ctDNA with recurrence in patients with stage II-IV colorectal cancer: The β-CORRECT study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. Chhatwal, J., Xiao, J., ElHabr, A., Tyson, C., Cao, X., Raoof, S., Fendrick, A. M., Ozbay, A. B., Limburg, P., Beer, T. M., Deshmukh, A., & Briggs, A. (2025). The potential of multi-cancer early detection screening in reducing cancer incidence and mortality in high-risk groups: A modeling study. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025 About Exact Sciences Corp. A leading provider of cancer screening and diagnostic tests, Exact Sciences helps give patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype DX® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook. NOTE: Oncotype DX Breast Recurrence Score and Oncodetect are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Exact Sciences, Cologuard, and Cancerguard are trademarks of Exact Sciences. Forward-Looking Statement This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs, or strategies regarding the future. These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding the performance characteristics and health care benefits of the Cologuard, Oncotype DX Breast Recurrence Score, Oncodetect, and Cancerguard EX tests in a commercial setting, as well as statements regarding the development and commercialization of Exact Sciences' pipeline tests. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.
