AI developer Lunit is ramping up its position in breast cancer risk prediction by acquiring Prognosia, the developer of a risk prediction algorithm spun out from Washington University School of Medicine in St. Louis. The move will complement Lunit and Volpara’s existing AI models for 2D and 3D mammography analysis.
Risk prediction has been touted as a better way to determine which women will develop breast cancer in coming years, and high-risk women can be managed more aggressively with more frequent screening intervals or the use of additional imaging modalities.
- Risk prediction traditionally has relied on models like Tyrer-Cuzick, which is based on clinical factors like patient age, weight, breast density, and family history.
But AI advancements have been leveraged in recent years to develop algorithms that could be more accurate than traditional models.
- One of these is Prognosia, founded in 2024 based on work conducted by Graham Colditz, MD, DrPH, and Shu (Joy) Jiang, PhD, at Washington University.
Their Prognosia Breast algorithm analyzes subtle differences and changes in 2D and 3D mammograms over time, such as texture, calcification, and breast asymmetry, to generate a score that predicts the risk of developing a new tumor.
- The algorithm was the subject of a positive study in JAMA Network Open in June in which it had better performance than the Tyrer-Cuzick model.
Prognosia built on that momentum by submitting a regulatory submission to the FDA, and the application received Breakthrough Device Designation.
- In conversations with The Imaging Wire, Colditz and Jiang believe AI-based estimates like those of Prognosia Breast will eventually replace the one-size-fits-all model of breast screening, with low-risk women screened less often and high-risk women getting more attention.
Colditz and Jiang are working with the FDA on marketing authorization, and once authorized Prognosia’s algorithm will enter a segment that’s drawing increased attention from AI developers.
- The two will continue to work with Lunit as it moves Prognosia Breast into the commercialization phase and integrates the product with Lunit’s own offerings like the RiskPathways application in its Lunit Breast Suite and technologies it accessed through its acquisition of Volpara in 2024.
The Takeaway
Lunit’s acquisition of Prognosia portends exciting times ahead for breast cancer risk prediction. Armed with tools like Prognosia Breast, clinicians will soon be able to offer mammography screening protocols that are far more tailored to women’s risk profiles than what’s been available in the past.
