4D Path, University of Leeds Extend Partnership to Validate Digital Pathology Diagnostic Platform

female scientist with a slide with a breast tumour
Female scientist showing a glass slide that has a sample from a great tumour on it.

Computer-aided cancer diagnostics company 4D Path, announced it is expanding its existing three-year partnership with the University of Leeds after positive results from three breast cancer clinical studies using the 4D Q-plasia OncoReader Breast diagnostic platform. The new deal runs through 2027.

“One in eight women will be affected by breast cancer in their lifetime, and improving diagnostic accuracy at the level of biopsies is becoming increasingly important to support clinical practice aimed at minimizing the severity of surgical intervention,” said Mr. Rodrigo Navarro, CEO at 4D Path. “We’re grateful to the University of Leeds for giving us the opportunity to work in an academic clinical setting to demonstrate both our strength in delivering various diagnostic outcomes for breast cancer, and our ability to enable essential molecular tumor profiling.”

Studies conducted to date at Leeds used H&E stained whole-slide biopsy images with the intent to test the 4D diagnostic technology’s ability to identify not only the presence of breast cancer, but also determine its subtype, grade, HER2 and hormone receptor status. The studies involved more than 400 patients and 700 images scanned across two different leading scanner platforms to demonstrate the robustness of the device across image formats.

“We are very excited by our study results which, when validated in large scale follow-on studies, could revolutionize the way we perform diagnoses, interact with our oncology colleagues and support patients,” said Dr. Rebecca Millican-Slater, NHS consultant breast histopathologist at Leeds Teaching Hospitals Trust (LTHT), who has been involved in the trial. “This ongoing partnership capitalizes and builds on our internationally recognized expertise in digital pathology.”

Massachusetts-based 4D Path was awarded an FDA Breakthrough Device Designation in November for its tehcnology platform. It applies a cloud-based, quantitative approach to find hidden data in biopsy and resection specimen pathology images. According to the company results from the platform have the potential to make significant improvements in the standard of care in breast cancer and has the potential to streamline the diagnostic process to begin and end at its method of diagnosing disease.

“The anxiety and distress associated with waiting for a confirmed cancer diagnosis has a marked detrimental impact on patients and their families’ quality of life and finances,” said Dr. Debbie Beirne, NIHR Leeds CRF manager/deputy director and cancer patient and public involvement (PPI) group Lead, National Health Service (NHS). “Improving the speed of the diagnostic process supports the initiation of primary treatment at the earliest possible opportunity.”

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