15 June 2022 - - US-based Paige, a specialist in clinical AI applications in pathology, has forged a collaboration with Janssen Research and Development, LLC to evaluate the potential of a hematoxylin and eosin -based, artificial intelligence -powered biomarker test to predict the presence of certain actionable alterations in the fibroblast growth factor receptor genes in patients with advanced urothelial cancer, also known as bladder cancer, the company said.

This biomarker test, developed by Janssen, is a first-of-its-kind screening tool to predict the occurrence of actionable genomic alterations.

The goal is to improve rates of confirmatory molecular testing and accelerate recruitment of patients into biomarker-driven clinical trials that are enrolling patients with certain tumor FGFR mutations.

Bladder cancer is the tenth most common cancer worldwide1, and approximately 15% of people with advanced disease have alterations in the FGFR gene.

Currently, most patients with bladder cancer do not have their tumors sequenced to identify potential genomic alterations and potentially inform more targeted treatment decisions.

For those who are tested, results from TODAY's confirmatory molecular FGFR tests can take weeks to be returned to the ordering physician, slowing time to trial enrollment and treatment.

Leveraging existing H and E data to provide guidance for care can reduce barriers for clinical trial recruitment by providing results for a digitized image of a routine biopsy in less than one hour.

The technology is currently being evaluated in Janssen's clinical trials to screen for FGFR gene alterations in adult patients with advanced urothelial cancer using the Paige Platform, a comprehensive digital pathology software platform that is inclusive of an FDA-cleared and CE-marked viewer and storage capabilities that is compatible with existing digital pathology solutions, including most scanners, monitors, and laboratory information systems.

As more clinical trial sites adopt a digital pathology workflow, Paige will be able to support local testing.

Paige was founded in 2017 by Thomas Fuchs, Dr.Sc., David Klimstra, M.D., and colleagues from Memorial Sloan Kettering Cancer Center.

The company builds computational pathology products designed so patients and their care teams can make effective, more informed treatment decisions.

With this new class of AI-based technologies positioned to drive the future of diagnostics, Paige created a platform to deliver this novel technology to pathologists to transform their workflow and increase diagnostic confidence and productivity.

Paige's products deliver insights to pathologists and oncologists so they can arrive efficiently at more precise diagnoses for patients. Paige is the first company to receive FDA approval for an AI-based digital pathology product, Paige Prostate Detect.