Washu Startup Prognosia Acquired By Lunit To Advance Ai-based Breast Cancer Prediction

Oct 14 2025

An innovative biotech startup founded by researchers astatine Washington University School of Medicine successful St. Louis has been acquired by Lunit, a starring institution successful processing AI-based technologies for crab prevention and early detection. The WashU startup, Prognosia, was created to create package that harnesses AI to analyse mammograms and much accurately foretell a woman's five-year consequence of processing bosom cancer.

The startup's first package package, Prognosia Breast, received Breakthrough Device Designation from nan Food and Drug Administration (FDA) earlier this year, putting it connected a accelerated way to afloat marketplace approval. Lunit's acquisition of Prognosia tin thief accelerate nan last steps of nan process to bring nan exertion into nan clinic.

Prognosia was co-founded by Graham A. Colditz, MD, DrPH, nan Niess-Gain Professor of Surgery astatine WashU Medicine and subordinate head of prevention and power at Siteman Cancer Center, based astatine Barnes-Jewish Hospital and WashU Medicine; and Shu (Joy) Jiang, PhD, an subordinate professor of room successful the Division of Public Health Sciences in the Department of Surgery at WashU Medicine.

"We are excited to activity pinch Lunit to bring this exertion to nan clinic," Jiang said. "Lunit already has nan infrastructure successful spot to streamline accumulation and objective implementation of our package that would beryllium extraordinarily difficult for a caller startup to build from scratch. Integrating our package into their existing systems could thief this caller exertion get into nan hands of physicians and patients very quickly."

The strategy produces a five-year bosom crab consequence people that makes it imaginable to comparison a woman's personalized consequence to an mean consequence based connected nationalist bosom crab incidence rates. This provides a meaningful estimate that is aligned pinch nan U.S. nationalist consequence simplification guidelines, truthful that clinicians will cognize what options to talk if a patient's bosom crab consequence is elevated.

"Improved consequence prediction tin thief early detection, which has nan imaginable to summation nan likelihood of successful curen that is little disruptive to people's lives," said Colditz, an internationally renowned crab prevention interrogator who has led nan section for decades. "We recognized that location is simply a tremendous wealthiness of accusation astir bosom crab improvement already stored and continuing to beryllium recently collected successful nan shape of regular mammograms. Until recently, location was nary measurement to usage this accusation to pass consequence prediction aliases to create caller and amended prevention strategies."

Improving accuracy

Past investigation led by Colditz and Jiang has shown their strategy is more than doubly arsenic accurate as nan modular method of identifying individuals astatine precocious consequence of processing bosom crab complete nan adjacent 5 years. The modular method is based connected questionnaires that see factors specified arsenic age, title and family history of bosom cancer. Research besides has shown that nan exertion maintains its precocious performance across aggregate demographic groups, including among group of divers races, ages and differing bosom densities.

These results led to nan technology's caller FDA Breakthrough Device designation, which provides an accelerated reappraisal process for afloat marketplace support pinch nan extremity of giving patients and clinicians entree to promising caller aesculapian devices sooner. The nickname recognizes that nan package already has undergone rigorous testing and has shown fantabulous committedness successful its imaginable to amended objective care.

The developers said nan exertion could beryllium easy integrated into existing objective workflows and is compatible pinch some types of mammogram imaging available: nan 4 2D views of nan bosom produced by full-field integer mammography and nan synthetic 3D position of nan bosom produced by integer bosom tomosynthesis.

A roadmap for growth

Colditz and Jiang worked pinch WashU's Office of Technology Management (OTM) to recovered their AI-based biotech startup.

Prognosia is simply a superb illustration of harnessing each nan resources disposable to WashU module to accelerate nan motorboat of a company. Dr. Colditz and Dr. Jiang were proactive successful adapting and learning done nan resources and guidance of WashU's OTM and nan entrepreneurship ecosystem of St. Louis. Through Lunit's acquisition of Prognosia, we're excited to spot this powerful startup task go moreover amended positioned to make transformative improvements successful bosom crab consequence estimation, prevention and early detection."

Nichole R. Mercier, PhD, adjunct vice chancellor and managing head of OTM

Colditz and Jiang said Prognosia would not person been imaginable without OTM's GAP backing program, which allowed them to do nan activity required for nan FDA's Breakthrough Device designation, arsenic good arsenic support from BioGenerator Ventures, which provided some financial support and expertise successful business strategy from Entrepreneur-in-Residence David Smoller, PhD.

"With nan guidance of OTM and David Smoller, we broadened our position beyond nan method aspects of nan package to attraction connected nan needs of nan health-care providers who will usage it to attraction for patients," Colditz said. "That displacement successful mindset has been important to processing a exertion that's genuinely useful successful nan objective setting."

Colditz and Jiang will clasp advisory roles astatine Lunit during nan pre-market reappraisal process that precedes afloat FDA support of nan exertion and for ongoing improvement projects. The regulatory scheme includes an first submission for nan fixed exemplary of consequence prediction based connected mammograms taken astatine a azygous timepoint, pinch a roadmap to grow functionality of nan package by analyzing mammograms from nan aforesaid personification taken astatine aggregate timepoints to amended nan accuracy of nan prediction.