The US Food and Drug Administration (FDA) has authorized marketing of artificial intelligence (AI) software to help pathologists detect prostate cancer. The program, called Paige Prostate, is the first approved AI system in pathology. "We really believe this product can make a huge difference," Paige CEO Leo Grady, PhD, told Medscape Medical News. The program was approved as an adjunct to pathologist review, not a replacement. Grady explained that "for a second opinion today, you ship a glass slide to somebody else or you do another stain that's really expensive or you do another molecular test."

"Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment," said Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health. "The authorization of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives." Cancer that starts in the prostate is called prostate cancer. According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, prostate cancer is the most common cancer among men in the United States.

NEW YORK--(BUSINESS WIRE)--Paige, the global leader in AI-based diagnostic software in pathology, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization for Paige Prostate, a clinical-grade AI solution for prostate cancer detection. As a novel technology, Paige Prostate is the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic (IVD) use via Paige's FDA-cleared FullFocus digital pathology viewer. With a projected 60 percent increase in the number of cancer cases globally in the next two decades and a decrease in the number of pathologists relative to this diagnostic demand, there is a significant need to provide new technologies for the practice of pathology. Paige Prostate is a cancer detection solution that identifies foci suspicious for cancer and provides this information to the pathologist. Paige Prostate is designed to assist pathologists in finding small foci of cancer and enable pathologists to work efficiently and confidently in their diagnostic process.

The FDA has authorized the marketing of Paige Prostate, an AI-based software platform to help pathologists identify prostate cancer when they review slide images from prostate biopsies.1 The standard biopsy review process involves the pathologist examining digitally scanned slide images from prostate biopsies to find areas that are suspicious for cancer. Paige Prostate provides a supplementary assessment of the image and locates the area with the highest probability of harboring cancer. The pathologist can then examine this specific area further if they did not identify it on their initial assessment. "Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment," Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, stated in a press release.

With the help of computational pathology firm Paige, healthcare technology giant Royal Phillips is bringing clinical artificial intelligence to pathology laboratories to help improve a pathologist's workflow and treatment planning for patients. According to a joint news release Thursday, this strategic collaboration will first start with Paige Prostate to help pathologists quantify and characterize cancer in tissue samples and make precise and efficient diagnoses. The release noted the need for more advanced cancer diagnosis technology as the number of cancer cases rises. Glass slide-based laboratory workflows are being converted to digital using solutions like ones offered by Phillips. Once digital images are created, the CE-marked Paige Prostate software is applied automatically to detect and localize prostate cancer, providing pathologists with valuable information they can use to evaluate prostate biopsies.