FDA clears AI-powered prostate cancer detection software

Software that can help pathologists detect prostate cancer from slides of biopsies more effectively has been approved by the FDA.

Paige Prostate is the first artificial intelligence-based software to be approved by the FDA for this purpose, according to the US regulator.

It is used to screen for signs of cancer on biopsy slides that have been digitised using a scanner, identifying those with the highest risk so they can be reviewed further by a pathologist if not spotted on an initial review.

"The authorisation of this AI-based software can help increase the number of identified prostate biopsy samples with cancerous tissue, which can ultimately save lives," said Tim Stenzel, director of the FDA's office of in vitro diagnostics and radiological health.

The approval is based on a clinical study where expert pathologists examined slide images of prostate biopsies – some with cancer and some without. For each slide image, the pathologists completed two assessments, one without Paige Prostate and one with the AI.

The results found that Paige Prostate – developed by Paige (formerly known as Paige.AI) – improved detection of cancer on individual slide images by 7.3% on average when compared to pathologists' unassisted reads, with a sensitivity of 98.9% and specificity of 93.3%, meaning the false positive rate was 6.7%.

That compared to 90.9% and 98.6%, respectively, with unassisted read, meaning that a higher detection rate was offset by a small increase in false positive or negative readings. Using the AI as an adjunct to review by a qualified pathologist mitigates that risk, according to the FDA.

With Paige, three new prostate cancer cases were discovered that were initially missed, according to the results of the trial, which were reported at last year's ASCO congress.

"Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day," said Stenzel. "Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment."

According to the Centers for Disease Control and Prevention (CDC), prostate cancer is the most common cancer among men in the US aside from non-melanoma skin cancer. It is also one of the leading causes of cancer death among men.

Paige has raised $220 million to date to provide funding for the roll-out of its "computational pathology" platform, most recently a $125 million Series C led by KKR and Johnson & Johnson's venture capital arm.