Paige Prostate – “The first and only AI-based pathology product to receive FDA approval for in vitro diagnostic (IVD) use in detecting cancer in prostate biopsies.”

Paige, which was founded in 2017 by Thomas Fuchs, Dr.Sc., David Klimstra, M.D. and colleagues from Memorial Sloan Kettering Cancer Center (MSK), has achieved the distinction of receiving the first ever FDA approval for an AI product in digital pathology. (MedCityNews)

Paige Prostate

Paige Prostate is a software tool that detects prostate cancer from prostate tissue slides. The AI enabled tool compares digital images of tissue slides with those in a cancer database and identifies foci suspicious for cancer and provides this information to the pathologist.

The tool lightens the workload of overworked pathologists because it can take up to an hour to check a slide manually for signs of cancer, according to Paige CEO Leo Grady.

“This landmark approval of Paige Prostate by the FDA marks the beginning of a new era in the use of computer-assisted diagnostics for pathology,” said David Klimstra, M.D., Co-Founder and Chief Medical Officer. “The approval reflects the rigor with which Paige Prostate has been validated, as the first clinical-grade AI technology to assist pathologists in the interpretation of routinely stained slides.”

Results of testing the software

To test its software, Paige randomly drew 527 slides of prostate biopsies from 150 institutions. These included 171 slides from cancer patients and 356 slides that were benign.

The slides were evaluated by pathologists and their findings were compared with those from Paige Prostate.

The results from the software for detection of cancer were 7.3% superior to those from manual inspection.

Furthermore, pathologists using the tool had a 70% reduction in false negative diagnoses and a 24% reduction in false positive diagnoses.

According to the FDA, the software should be augmented by a final decision from a pathologist.

“FDA approval allows pathology laboratories to introduce this diagnostic tool into their clinical workflow to help make pathologists more accurate, more reproducible, and more efficient, which will allow them to focus their attention on the most critical aspects of establishing the diagnosis,” said Klimstra.

Paige Prostate is now available for diagnostic use in the U.S., the company announced.

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Image credit: Paige