NEW YORK — Paige on Wednesday said that it will work with Janssen Research & Development to assess the ability of a screening tool developed by Janssen to predict the presence of fibroblast growth factor receptor (FGFR) genes in patients with advanced bladder cancer.
The test relies on screening hematoxylin and eosin (H&E)-stained slides and is aimed at improving rates of confirmatory molecular testing while increasing recruitment of patients into biomarker driven clinical trials, Paige said.
Currently, the test is being evaluated in Janssen's clinical trials using the Paige Platform to screen for FGFR gene alterations in adult patients with advanced urothelial cancer. The Paige Platform is a digital pathology software platform that includes a viewer and storage capabilities that are compatible with existing digital pathology systems. Paige Platform is cleared by the US Food and Drug Administration and CE marked.
Jill Stefanelli, Paige's president and chief business officer, said in a statement that by deploying Janssen's AI technology to detect biomarkers, Paige was marking a "new chapter" in its story, and that the company intends to make its platform more broadly available to "support the clinical development of targeted and other classes of therapeutic drugs and patient identification for future biomarker and drug development programs."
Paige last year received US Food and Drug Administration clearance for an AI-based test to diagnose prostate cancer. Last month, it said it has received a CE-IVD mark and a UK Conformity Assessed mark for the same offering.