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, says.
The program was approved to help doctors, not to replace them.
"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,” Grady says.
With the new tool, doctors digitally scan and upload biopsy slides to a computer, then import them into the program, which is a cloud-based service accessed through a Web browser.
The software compares the tissue patterns against a large database of tissue patterns collected at the Memorial Sloan Kettering Cancer Center, which created Paige as a company in 2018 from its work on digitizing biopsy slides.
The program looks for patterns that have been previously diagnosed as cancer. When it finds such patterns, it highlights them for the pathologists to key in on, so they "don’t miss anything" and have "a lot more confidence in their diagnosis without having to send it out for additional consultation," Grady says.
Shortly after the FDA announced the authorization on Sept. 21, the FDA's acting commissioner, Janet Woodcock, MD, tweeted that she's "always pleased to see potentially life-saving advancements in medical device technology, such as using artificial intelligence to help identify prostate cancer."
The FDA approval was based on a study where 6 pathologists examined 527 digitally scanned prostate biopsy slides. Of them, 171 were cancerous, and 356 were benign. The pathologist made two assessments, one with and one without the program's help.
The software improved detection of cancer on individual slide images by 7.3% on average compared to unassisted reads. There was no impact on the reading of benign slides.
The FDA said that the risk for false negatives and false positives with the program is lessened because it is used along with a doctor and by the pathologists' consideration of patient history, laboratory studies, and other clinical information.
“Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day,” Tim Stenzel, MD, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said in a statement. “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.”