USA – Paige has announced a collaboration with Janssen Research & Development to evaluate the potential of a hematoxylin and eosin (H&E) and artificial intelligence (AI)-based biomarker test.

Developed by Janssen, the test is a first-of-its-kind screening tool to predict the occurrence of actionable genomic alterations, Paige said.

The tool is designed 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.

With the collaboration, the firms aim 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, Paige said.

Paige noted that results from current confirmatory molecular FGFR tests can take weeks to be returned to the ordering physician.

“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,” it said.

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.

Paige called the test, developed by Janssen, a “first-of-its-kind screening tool” to predict the occurrence of actionable FGFR2 and FGFR3 genomic alterations within seconds.

Paige stated that as more trial sites adopt a digital pathology workflow, it will be able to support local testing.

Paige received CE-IVD and UKCA certifications earlier this year for its AI software designed to detect breast cancer metastases in lymph nodes.

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 digital pathology software platform.

Meanwhile, the Paige Prostate Biomarker Suite was CE-IVD and UKCA (UK Conformity Assessed) – approved last month, and its prostate cancer detection tool was FDA-approved last year.

Paige’s partnership with iCAIRD

Further to that, Scotland’s Industrial Centre for Artificial Intelligence Research in Digital Diagnostics – (iCAIRD) has partnered with Paige to provide “radical improvements” in the early detection of cancer.

The partnership aims to speed up diagnosis of prostate cancer by improving advanced algorithms.

The organizations will create a fully digital workflow – the automation of processes and steps required to complete work and achieve goals – at NHS Greater Glasgow and Clyde (NHSGGC), as part of a study into how data gathered from the use of AI can help pathologists with decision-making and efficiency.

It is hoped this will have a positive impact on waiting times and result in faster diagnosis for patients in the future.

As part of the partnership between iCAIRD and Paige, the University of St. Andrews School of Computer Science will also research and develop algorithms for women’s health applications, including screening of endometrial and cervical biopsy tissue for cancer.

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