With a projected FDA submission within the next two to three years, Harbinger is prioritizing cancers based on lethality, prevalence, and unmet diagnostic need. Pancreatic and biliary cancers – often diagnosed at late stages and lacking established screening programs – will be among the initial targets.
The Cambridge, MA-based company presented two late-breaking abstracts at the American Association for Cancer Research (AACR) Annual Meeting on 29 April.
Key Takeaways
Harbinger’s MCED test integrates a machine-learning model (MLX) with intra-individual methylation analysis (IIX), achieving 99.5% specificity and up to 80.7% positive predictive value for hard-to-detect cancers.
Harbinger Health is advancing a blood-based screening platform initially focused on pancreatic and biliary cancers – two of the deadliest...
The US FDA has approved Medtronic’s Altaviva, a subcutaneous device implanted near the ankle that offers a new treatment option for adults with urge urinary incontinence.
The new ESC and EACTS guidelines allow aortic stenosis patients without symptoms to be considered for a transcatheter aortic valve replacement. The move opens the market for Edwards Lifesciences, the only medtech with a Europe and US-approved device for asymptomatic severe aortic stenosis.