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.
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Salmon, Bella n°: 2325Presentation: June 14th, 2025. 10:00 AM CEST About HSS HSS is the world's leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 15th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2024-2025), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report "Best Children's Hospitals" list (2024-2025). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked world #1 in orthopedics for a fifth consecutive year (2025). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. 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The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. View source version on Contacts Tracy Hickenbottom/Rachael Rennich212-606-1197mediarelations@ Error 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
