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Harbinger Health Showcases Multi-Cancer Early Detection Performance in High-Risk Populations at ASCO 2025
Harbinger Health Showcases Multi-Cancer Early Detection Performance in High-Risk Populations at ASCO 2025

Yahoo

time31-05-2025

  • 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

Team develops esophageal cancer prediction method using the inside of the cheek
Team develops esophageal cancer prediction method using the inside of the cheek

Japan Times

time29-05-2025

  • Health
  • Japan Times

Team develops esophageal cancer prediction method using the inside of the cheek

A team of Kyoto University and other researchers has developed a method of predicting with high accuracy the risk of someone developing esophageal cancer by analyzing cells collected from inside the person's cheeks. If brought into practical use, the method could facilitate early cancer detection and cancer prevention through lifestyle improvements. The team's findings were published in an online international medical journal in April. Its study covered 222 people age 40-94, all with a history of smoking and drinking who either had esophageal cancer or did not. The team swabbed the inside of their cheeks to extract cheek mucosa cells and analyzed any genetic mutations. Participants with a lower tolerance for alcohol had more genetic mutations in their extracted cells when their alcoholic intake increased. On the other hand, those whose bodies were capable of processing alcohol well did not display such an increase. The team also found that esophageal cancer patients had more genetic mutations than those who did not, even if their cancer was discovered at an early stage. The team managed to make cancer probability predictions with an accuracy of over 70% by analyzing various genetic mutation data together. The team found "what is believed to be a biomarker that indicates (cancer) risks more objectively and accurately than with the conventional method of interviewing (patients) on their lifestyle habits and predispositions," said team member Akira Yokoyama, lecturer at Kyoto University Hospital.

SeekInCare: New Multi-Omics Blood Test Shows Promise for Early Cancer Detection Across Multiple Cancer Types
SeekInCare: New Multi-Omics Blood Test Shows Promise for Early Cancer Detection Across Multiple Cancer Types

Yahoo

time26-05-2025

  • Health
  • Yahoo

SeekInCare: New Multi-Omics Blood Test Shows Promise for Early Cancer Detection Across Multiple Cancer Types

SAN DIEGO, May 26, 2025 /PRNewswire/ -- A groundbreaking study published in the Journal of Molecular Diagnostics reports the successful clinical validation of SeekInCare®, a novel, non-invasive multi-omics blood test designed for the early detection of multiple cancer types. Developed by researchers at SeekIn Inc., SeekInCare integrates advanced genomic, epigenetic, and proteomic analyses to identify cancer at its early stage, offering hope for improved outcomes through earlier intervention. Key Findings Comprehensive Cancer Detection: SeekInCare leverages shallow whole-genome sequencing of cell-free DNA (cfDNA) and measures seven protein tumor markers from 8ml peripheral blood. The test analyzes multiple cancer hallmarks, including copy number aberration, fragment size, end motif, and oncogenic virus, combined with artificial intelligence algorithms to distinguish cancer patients from non-cancer individuals and predict the likely tissue of origin. Robust Clinical Validation: In a retrospective study involving 617 cancer patients (across 27 cancer types) and 580 non-cancer individuals, SeekInCare achieved a sensitivity of 60.0% at 98.3% specificity, with an area under the curve (AUC) of 0.899. Sensitivities increased with cancer stage: 37.7% (stage I), 50.4% (stage II), 66.7% (stage III), and 78.1% (stage IV). Real-World Evidence: The test was further validated in a prospective cohort of 1,203 individuals, achieving 70.0% sensitivity at 95.2% specificity over a median follow-up of 753 days. Comparable to Leading Tests: SeekInCare's performance is on par with other multi-cancer early detection (MCED) tests currently in development, demonstrating its potential as a valuable tool for population-level cancer screening, especially in high-risk groups. Addressing Unmet Needs in Cancer Screening Despite advances in cancer therapeutics, most cancers are still diagnosed at advanced stages, where treatment is less effective. Traditional screening methods are limited to specific cancer types and often involve invasive procedures that can deter participation. SeekInCare's blood-based, multi-omics approach addresses these limitations by enabling non-invasive, broad-spectrum cancer detection from a single blood draw. "Our findings demonstrate that integrating multiple molecular signatures from blood can significantly enhance the sensitivity and specificity of early cancer detection," said Dr. Mao Mao, corresponding author and Founder & CEO at SeekIn Inc. "SeekInCare's robust performance in both retrospective and prospective cohorts supports its potential clinical utility as a screening tool, particularly for high-risk populations." The study was a collaborative effort involving leading hospitals in China. The publication can be found at About SeekInCare® With the mission to detect cancer while it is still curable, SeekInCare® has been developed as a pan-cancer detection test that takes a panoramic view of blood cell-free cancer signatures and a multi-omics approach incorporating genomic and epigenetic alterations in conjunction with clinically validated protein biomarkers. Equipped with proprietary AI- and big data-driven CRS algorithm, SeekInCare exhibits superior effectiveness to detect dozens of cancer types at high specificity. SeekInCare is intended for use in individuals with elevated risks of cancer such as smoking, chronic hepatitis, aging, etc., in conjunction with the approved conventional single-cancer type screening tests. SeekInCare received CE-IVD Mark in November 2021. About SeekIn SeekIn Inc. is a biotech company founded in early 2018 in Shenzhen, China, focusing on blood-based pan-cancer early detection utilizing next-generation sequencing and artificial intelligence. Since its creation, SeekIn has been committed to providing cutting-edge and cost-effective solutions for cancer early detection, postoperative recurrence monitoring, and treatment response evaluation. SeekIn has also developed novel molecular tests for leukemia patients and its cancer early detection technology has also successfully been applied to canines. With its proprietary technical advances, SeekIn has launched a number of research and clinical studies in collaboration with top-tier hospitals in China. SeekIn envisions that, by leading a new norm for cancer early detection, the clinical outcomes of mid-/late-stage cancer patients can be reversed, and the cancer mortality rate can be reduced by 15%. For more information about SeekIn's cutting-edge technologies and products, visit View original content: SOURCE SeekIn Inc Sign in to access your portfolio

Prototype 'to light up' hidden breast cancers
Prototype 'to light up' hidden breast cancers

BBC News

time14-05-2025

  • Health
  • BBC News

Prototype 'to light up' hidden breast cancers

A prototype scanner designed to detect cancerous tumours in women with dense breast tissue could "ultimately save more lives", researchers say. Dense tissue shows up as white on mammograms, but tumours are also white - so they can be hard to detect. Developed by technology group Kromek in partnership with Newcastle Hospitals, Newcastle University and University College London (UCL), the new imaging uses a radioactive tracer that "lights up" breast cancers. The project is set to enter clinical trials once testing is complete. Dr Nerys Forester, a consultant breast radiologist at Newcastle Hospitals, said "around 40% of women have dense breast tissue, but this only becomes evident when they attend their mammogram". She said it was not usually a cause of concern as screening with mammogram was effective, but "women with dense breast tissue do have a slightly increased risk of getting breast cancer".When breasts are very dense they show up on a mammogram as white, she said, "so we are looking something white in the midst of potentially a lot of white tissue". It is often described as "looking for a little white cloud in a cloudy sky".Dr Forester said new technologies to improve the detection of cancer in dense breasts was "really important" and she was delighted with progress of the new prototype since the project began in 2022. "Our hope is that this technology could ultimately save more lives lost to breast cancer in the future," she said. Aly Murphy, a nurse and breast cancer patient, has been involved in the research, which she describes as "thrilling". The 65-year-old said she found out by accident that she had dense breast tissue and believes it is possible her cancer could have otherwise been been missed. She describes the project as "pushing the boundaries of screening, and that's what we really need to do". "I find it absolutely exciting. I think it's revolutionary." Technology company Kromek, based in Sedgefield, County Durham, holds contracts with the Ministry of Defence supplying nuclear radiation executive Dr Arnab Basu hopes his machine will also detect these difficult-to-diagnose breast cancers."It is very similar to nuclear medicine in other parts of diagnostic imaging," he said. "The patient will be injected with a tracer that is designed to deposit on nuclear cells."He said the technology allowed laser focus on the cancer cells, and they "literally light up". Prototype trials are now under way at Newcastle Hospitals. Its Northern Medical Physics and Clinical Engineering team is leading on the device regulation, and the National Institute for Health and Care Research HealthTech Research Centre in Diagnostic and Technology Evaluation is also involved. Prof Kris Thielemans, professor in medical imagine physics at UCL, said the collaboration between teams had "made excellent progress", adding he believed the technology had "considerable potential" for use beyond breast imaging. The project has received £2.5m from Innovate UK. It will enter clinical trials once the current phase of prototype testing is completed. Breast Cancer Now's Sally Kum said the charity "wholeheartedly" supported the "ongoing research into breast imaging technologies that could improve cancer detection in dense breasts".Ms Kum said if the government's UK National Screening Committee found that evidence supported a specific approach to measuring breast density and offering alternative imaging for screening women with dense breasts, "we'll push for those changes to be rolled out as quickly as possible across the UK".She added the charity still encouraged eligible women to attend mammogram screening when invited. Follow BBC North East on X, Facebook, Nextdoor and Instagram.

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