The study aimed to measure the usefulness of Paige Prostate in triaging prostate cancer cases in a real-world setting. Paige and Oncoclinicas evaluated the diagnostic accuracy and efficiency of three pathologists and Paige Prostate in diagnosing 682 transrectal ultrasound guided prostate needle biopsy slides from 100 consecutive patients. Paige Prostate had 100% sensitivity (1.0; CI 0.93-1.0) and a 100% negative predictive value (1.0; CI 0.91-1.0) at the patient level. Paige Prostate reduced time to diagnosis by an estimated 65.5% for the material analyzed.

Oncoclinicas has become a leader in the artificial intelligence revolution in diagnostic pathology by becoming the first institution worldwide to commercially implement FullFocus™, Paige’s web-based digital pathology viewer, and AI-driven Paige Prostate for routine use, spearheading the replacement of traditional analog pathology processes with a fully digital workflow. The cancer center network previously joined Paige’s Early Access program, which allows institutions to test Paige’s cutting-edge solutions for digital pathology diagnosis.

“The study demonstrates the important impact the AI powered Paige Prostate diagnostic tool can have on routine diagnostic pathology. Paige Prostate helped us improve our diagnostic accuracy through its AI technology and also increased our efficiency by streamlining our day-to-day workflow,” said Leonard Medeiros da Silva, Ph.D., Pathologist with Oncoclinicas Precision Medicine (the integrated Genomics and Pathology operations at Grupo Oncoclinicas) and first author of the study. “We chose to go digital with Paige because it was the first AI cancer diagnostic platform that met our validation requirements for implementation into our clinical environment. Paige’s pipeline of AI diagnostic tools for other major cancer tumor types also differentiated them. The workflow and digital platform will also enable us to distribute work across our nationwide network of pathologists.”

Dr. Bruno Ferrari, founder and chairman of the Board of Directors of Grupo Oncoclinicas added: “This is a crucial step Grupo Oncoclinicas is taking to bring together cutting-edge digital pathology, genomics, ‘big data’ and AI to offer our patients an optimal and individualized treatment.”

“We are delighted to complete the full deployment of our digital and computational pathology products in a clinical setting and to partner with Oncoclinicas to demonstrate the potential of Paige Prostate’s workflow improvements as well as its efficacy in a diversity of clinical environments,” added Leo Grady, Ph.D., Chief Executive Officer of Paige. “We remain committed to building an industry-leading portfolio of AI-based clinical and research applications, biomarkers and diagnostics and delivering those products to health systems and laboratories around the world.”

*Paige Prostate is CE marked for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK, and received Breakthrough Device designation by the U.S. Food and Drug Administration (FDA). FullFocus is FDA cleared and CE marked. The products are otherwise available for research use only in other territories.

Read the full study in the Journal of Pathology.

About Paige

Paige was founded in 2017 by Thomas Fuchs, Dr.Sc. 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 breakthrough designation for computational pathology products.