The new capability strengthens clinical decision-making for neoadjuvant therapy.

Stratipath, the AI company pioneering a faster, cost-effective approach to cancer precision diagnostics, today announced a coming update of its CE-IVD marked solution, Stratipath Breast. This AI-powered prognostic risk profiling tool can now be used not only on resected tumours but also on core needle biopsies, unlocking new possibilities for earlier and more informed treatment planning for breast cancer patients.

Stratipath Breast leverages deep learning to analyse standard H&E-stained slides from preoperative biopsies, and stratifies invasive early-stage breast cancers into low-risk to high-risk classification levels, within one hour. This enhances decision support ahead of surgery, particularly for patients being considered for neoadjuvant chemotherapy.

 “With the new support for biopsies, Stratipath Breast can be implemented even earlier in the diagnostic workflow,” said Professor Johan Hartman, Senior Physician at Karolinska University Hospital and Chief Medical Officer at Stratipath. “This opens up important new opportunities to improve treatment decisions and patient outcomes already at the time of diagnosis.”

Histological tumour grading of biopsies plays a crucial role in treatment decisions, especially for ER+ breast cancer. However, grading of biopsies is often inconsistent—or not performed at all. Stratipath Breast offers an independent alternative for risk stratification even when traditional grading is inconclusive. For triple-negative and HER2+ breast cancer, the AI tool may aid in identifying patients with particularly aggressive or less aggressive disease—adding further nuance to personalised care decisions.

“This is a unique opportunity to bring precise and rapid decision support to a broader group of breast cancer patients, especially those being evaluated for neoadjuvant treatment,” said a leading oncologist currently using the solution in clinical practice.

Stratipath Breast is already being used for resected tumours in clinical routine in several European hospitals and is mentioned in the Swedish national breast cancer care program as a decision support tool in the diagnostic evaluation of breast cancer. With a cost per analysis of just a fraction compared to molecular assays and a turnaround time of within one hour, it helps reduce healthcare costs, free up resources, and significantly shorten time to treatment—all while increasing access to high-quality precision diagnostics.

Stratipath Breast analysis of biopsies will soon be available.