Latest news with #HutanAshrafian
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
Yahoo
25-04-2025
- Health
- Yahoo
Harbinger Health Unveils Promising New Data on Early Cancer Detection Platform at AACR 2025
Novel analytical framework establishes a clinically meaningful performance assessment of blood-based early detection tests Innovative methodology enhances cancer signal detection, boosts specificity and predictive value Presentations further validate the HarbingerHx platform and its utility in early cancer detection CAMBRIDGE, Mass., April 25, 2025 (GLOBE NEWSWIRE) -- Harbinger Health, a biotechnology company pioneering the detection of early cancer, today announced the presentation of two late-breaking presentations at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois from April 25-30, 2025. Presentations describe innovations that establish both a novel analytical framework and an enhanced laboratory methodology that improve the performance assessment and clinical utility of Harbinger's blood-based multi-cancer early detection (MCED) tests. Harbinger Health is pioneering the detection of early cancer and enabling foundationally new approaches to cancer screening, diagnosis and management by bringing together unique insights into the biology of cancer's origin with artificial intelligence and the latest screening technologies. The company has developed a platform for developing novel diagnostic and screening products in multiple clinical settings and cancer indications. 'While innovations in cancer therapy have revolutionized the treatment landscape, the tools to detect and diagnose it early when survival rates are highest have lagged behind,' said Hutan Ashrafian, M.D., Ph.D., M.B.A, Chief Medical Officer. 'At Harbinger, our mission is to disrupt conventional cancer detection approaches that either lack an appropriately high diagnostic accuracy for clinically impactful outcomes or only provide detection for a single cancer at a time. By pioneering blood-based tests based on DNA methylation signatures with novel applications including sequential reflex testing and individualized analyses, we aim to provide solutions that give physicians highly accurate and reliable information to get their patients on the right treatment pathways, right away. The data presented today underscore our commitment to setting a new standard in quantifying test performance, with the ultimate goal of adequately informing earlier clinical intervention and improving outcomes for patients across a wide spectrum of cancers.' Harbinger conducted the Cancer ORigin Epigenetics-Harbinger Health (CORE-HH) study (NCT05435066) to support the continued development and validation of Harbinger's platform technology for the detection of early-stage disease across multiple cancer types. The primary objectives of the case-controlled study, which enrolled a diverse and representative cohort of individuals with and without cancer, included evaluating the diagnostic accuracy of its proprietary assay and assessing its ability to determine cancer tissue of origin. Data and samples collected as part of CORE-HH formed the basis for the development and evaluation of the novel analytical framework and methodology presented at the AACR Annual Meeting 2025. Key highlights from the late-breaking presentations include: Title: Sharpening the signal: Enhancing liquid biopsy specificity through intra-individual methylation analysisDate: Tuesday, April 29, 2025Time: 9:00 a.m. – 12:00 p.m. CT in Section 51Key Highlights: A methodology based on Harbinger's proprietary methylation biomarkers and a paired intra-individual analysis (IIA)—comparing plasma-derived cell free DNA (cfDNA) to matched white blood cell (WBC)-derived genomic DNA (gDNA)—was developed and tested on CORE-HH data, to differentiate circulating tumor DNA (ctDNA) from background somatic noise. Harbinger combined two approaches: a cfDNA-based machine learning classifier (MLX) and a patient-specific intra-individual classifier (IIX), integrating them into a two-tier system. Together, these methods achieved higher overall specificity than either approach alone. When MLX and IIX were both set to a target specificity of 98.5%, the achieved sensitivity and specificity was 63.7% and 99.5% with a PPV of 54.8%, When MLX and IIX were both set to target specificities of 99.5%, the achieved sensitivity and specificity was 55.1% and 99.89% with a Positive Predictive Value (PPV) of 80.7%. Title: Novel performance quantification of MCED testing to aid clinical decisions: Analysis of a sequential reflex blood-based methylated ctDNA testDate: Tuesday, April 29, 2025Time: 9:00 a.m. – 12:00 p.m. CT in Section 51Key Highlights: A novel framework was developed for the performance assessment of MCED testing and applied to data from the CORE-HH study, quantifying clinically meaningful and actionable metrics relevant to real-world utility. The test achieved a specificity of 98.6%, representing an important benchmark for population-level screening resulting in a low false-positive rate critical to minimizing downstream diagnostic burden. Results demonstrate promise for the test to detect certain cancers currently lacking organized screening programs in the general population such as pancreaticobiliary (identification of 32 of 49 cases) and hepatobiliary cancer. Cancers with very high Positive Predictive Values (PPV) — upper gastrointestinal (91%), colorectal (77%), and hepatobiliary cancers (73%) — demonstrate exceptionally favorable risk-benefit profiles, as the high likelihood of true disease minimizes unnecessary interventions. 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@ in to access your portfolio
