A newly approved software was found effective in assisting pathologists in detecting prostate cancer on biopsy slide images.

The U.S. Food and Drug Administration authorized marketing of Paige Prostate in September. The software aids in detecting areas suspicious for cancer as a supplement to pathologists’ review of digitally scanned slide images of prostate biopsies.

Paige says the product is the first artificial intelligence-based software designed to identify an area on a biopsy image that has a high likelihood of harboring cancer, enabling it to then be reviewed by a pathologist. It’s also the first AI-based pathology product to receive de novo approval from the FDA, allowing in vitro diagnostic use.

The CDC predicts the total number of cancer cases in the United States to increase by almost 50 percent by 2050 as a result of population growth and aging. That creates a need for new, diagnostic technologies in the field of pathology.

The FDA evaluated data from a clinical study in which 16 pathologists examined 527 slide images of prostate biopsies — 171 cancerous and 356 benign — that had been digitalized by a scanner. Each pathologist performed an assessment both with and without the assistance of Paige Prostate. The clinical study did not evaluate the impact of final patient diagnosis as that is typically done based on multiple biopsies.

The study found that Paige Prostate improved detection of cancer on individual slide images by 7.3 percent compared with a pathologist’s unassisted read. Pathologists using Paige Prostate had a 70 percent reduction in false negative diagnoses and a 24 percent reduction in false positive diagnoses.

False positive or negative diagnoses are listed as risk factors associated with the product, which is why it received marketing approval for use as an adjunct to a pathologist reviewing slide images. Pathologists must still consider each patient’s history as well as other clinical factors.

Prostate cancer is second only to skin cancer as the most common cancer in American men, according to the American Cancer Society. One in eight men will be diagnosed in his lifetime. It is also the second leading cause of cancer death in American men, behind lung cancer.