Paige Announces Collaboration to Deploy a Novel AI-Based Biomarker Test for Advanced Bladder Cancer in Clinical Settings

NEW YORK--(BUSINESS WIRE)-- Paige, a global leader in clinical AI applications in pathology, today announced a collaboration with Janssen Research & Development, LLC (Janssen) to evaluate the potential of a hematoxylin and eosin (H&E)-based, artificial intelligence (AI)-powered biomarker test to predict the presence of certain actionable alterations in the fibroblast growth factor receptor (FGFR) genes in patients with advanced urothelial cancer, also known as bladder cancer.

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.^2,3 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&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 (LIS). As more clinical trial sites adopt a digital pathology workflow, Paige will be able to support local testing.

“We are excited to mark a new chapter in deploying Janssen’s AI technology in a clinical setting to efficiently detect biomarkers, in this case some rare gene mutations and fusions,” said Jill Stefanelli, Ph.D., President and Chief Business Officer at Paige. “With the global deployment of our Paige Platform underway, we will make our capability broadly available in support of the clinical development of targeted and other classes of therapeutic drugs and patient identification for future biomarker and drug development programs.”

About Paige

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

For additional information, please visit: https://www.paige.ai, Twitter and LinkedIn.

¹ Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68(6):394-424.
² Helsten et al. The FGFR Landscape in Cancer: Analysis of 4,853 Tumors by Next-Generation Sequencing. Clin Cancer Res. 2015;22(1):259-267.
³ Tomlinson et al. FGFR3 protein expression and its relationship to mutation status and prognostic variables in bladder cancer. J Pathol. 2007;213(1):91-98.

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