National Institute for Health and Care Excellence Publishes Medtech Innovation Briefing on Paige Prostate

First-ever medtech innovation brief for digital pathology demonstrates potential of Paige Prostate in improving detection of prostate cancer and improving efficiency within pathology workflows

NEW YORK & LONDON–(BUSINESS WIRE)–Paige, the global leader in AI-based diagnostic software in pathology, today announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) published a Medtech Innovation Briefing (MIB) on Paige Prostate, a clinical-grade artificial intelligence (AI)-based diagnostic software system that aids pathologists in detecting, grading and measuring prostate tumors in biopsies obtained from patients at risk of prostate cancer.* This marks the first-ever MIB for a digital pathology product.

NICE conducted a systematic literature review and thoroughly evaluated five peer-reviewed clinical utility studies that included a total of 3,444 prostate needle biopsies. Based on the evidence evaluated, Paige Prostate may be an effective addition to standard care to increase sensitivity in detecting prostate cancer, and it may also help more efficient analysis to support the demands of high caseloads in the field.

“We are pleased that NICE has conducted a fastidious review of the available clinical literature on Paige Prostate, guided by neutrality and the strictest criteria,” said David Klimstra, M.D., Co-Founder and Chief Medical Officer at Paige. “This MIB will help decision makers in the NHS and beyond to assess the value and potential of Paige Prostate.”

MIBs are commissioned by the National Health Service (NHS) in England and are designed to support NHS and social care commissioners and staff who are considering using new medical devices. The briefing includes a description of Paige Prostate technology, how it is used, clinical and technical evidence and perspectives from expert pathologists consulted in the development of the MIB.

“Ultimately, we aim to measurably improve outcomes and experiences for patients, which is why we developed Paige Prostate to have the highest standards of performance and robustness. This first-ever digital pathology NICE advice for clinicians will further help bring these systems into real-world clinical use to fully realize their potential,” said Thomas J. Fuchs, Dr.Sc., Co-Founder and Chief Scientist at Paige, and Dean of Artificial Intelligence and Human Health at Mount Sinai. “We are pleased to see that the UK is leading the way in the adoption of digital pathology tools. This NICE advice provides important information to clinicians so that they access essential information on this system was developed, and its potential to further impact routine clinical practice.”

Additionally, Paige is currently working with Oxford University and regional NHS partners to study Paige Prostate prospectively in a real-world pathology laboratory setting and generate new health economics evidence as part of a successful Phase 4 NHSx Artificial Intelligence Health and Care Award.

Read the full MIB here: https://www.nice.org.uk/advice/mib280

* In the U.S., Paige received FDA market authorization to assist pathologists in the detection of foci that are suspicious for prostate cancer. Outside of the U.S., Paige Prostate is CE-marked for the detection, grading and quantification of prostate tumors for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK. FullFocus™ is FDA cleared and CE-marked. The products are otherwise available for research use only in other territories.

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.

SOURCE: BusinessWire