Primary diagnosis of prostate cancer by AI authorised by FDA
Paige, a leader in AI-based diagnostic software in pathology, has announced that the US Food and Drug Administration (FDA) has granted marketing authorisation 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% 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.
“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. 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. This innovation paves the way for the introduction of numerous future tools to help standardise pathology diagnosis, expedite the diagnostic process, and provide pathologists and patients greater comfort from the added scrutiny of their pathology slides,” said Dr David Klimstra, co-founder and Chief Medical Officer at Paige. “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.”