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New artificial intelligence tool may ‘save lives’ detecting prostate cancer, FDA says

Detection results have improved by 7.3% compared to standard testing, the FDA said.
Cancer cells - microscope image
This undated microscope image provided by the National Institutes of Health shows cancer cells with the cell nuclei stained red. The U.S. Food and Drug Administration approved the use of Paige Prostate, the first AI-based software that can identify cancerous slide images with better accuracy. (NIH via AP)

Artificial intelligence is playing a crucial role in detecting prostate cancer, according to the U.S. Food and Drug Administration.

The federal agency approved the use of Paige Prostate, the first AI-based software that can identify cancerous slide images with better accuracy.

Detection results have improved by 7.3% compared to standard testing, the FDA said.

“Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day,” Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a Tuesday news release. “Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment.”

Paige Prostate works by identifying “an area of interest on the prostate biopsy image with the highest likelihood of harboring cancer.” Those images are then reviewed by a pathologist if “the area of concern” was not detected by the AI software.

The FDA analyzed findings from a clinical study that involved 16 pathologists evaluating 527 prostate images — 171 were cancerous and 356 were benign.

Pathologists completed one assessment involving Paige Prostate and the other without the help of the software, the FDA said.

Although the “clinical study did not evaluate the impact on final patient diagnosis,” it did find that “Paige Prostate improved detection of cancer on individual slide images by 7.3% on average.”

However, Paige Prostate may produce “false negative and false positive results,” according to the FDA. Pathologists must take patient history into account along with performing “additional laboratory studies” on cancerous samples before making a final diagnosis.

The FDA approved the marketing of Paige Prostate and is coming up with additional requirements “related to labeling and performance testing” of the AI software.

Prostate cancer is the “most common cancer among men” in the U.S. other than non-melanoma skin cancer, and is one of the leading causes of death among men, according to the Centers for Disease Control and Prevention.

“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,” Stenzel said in the release.

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