The US FDA has granted Paige Prostate de novo marketing authorization, making it the first artificial intelligence (AI)-based pathology product to be approved. Paige Prostate is used with the company’s FullFocus digital pathology viewer, approved earlier, to detect prostate cancer.
“The approval is a landmark achievement in the field of digital pathology and demonstrates how robust our technology is when faced with the broad range of natural variations in tissue slides encountered in day-to-day clinical practice,” said Leo Grady, PhD, Chief Executive Officer of Paige. “We are grateful for everyone at Paige and our clinical partners who have brought this new generation of computational pathology products to reality.”
Outside of the U.S., Paige Prostate is CE-marked for use in laboratories and hospitals in the European Economic Area, Switzerland and the UK. FullFocus is FDA cleared and CE-marked. The company has been racking up deals and dollars. In March of this year it secured Series C Funding of over $125 million, it has raised over $220 million to date. Paige’s collaborators now include Oxford University, the UK NHS, Quest Diagnostics, Inform Diagnostics, Leica Biosystems, and Agendia. Besides the prostate product, the company is seeking approval for other products including one for breast cancer.
As part of this approval, FDA evaluated data from a clinical study where 16 pathologists examined 527 slide images of prostate biopsies (171 cancer and 356 benign) that were digitized using a scanner. For each slide image, each pathologist completed two assessments, one without Paige Prostate’s assistance (unassisted read) and one with Paige Prostate’s assistance (assisted read).
While the clinical study did not evaluate the impact on final patient diagnosis, which is typically based on multiple biopsies, the study found that Paige Prostate improved detection of cancer on individual slide images by 7.3% on average when compared to pathologists’ unassisted reads for whole slide images of individual biopsies, with no impact on the read of benign slide images.
Pathologists using Paige Prostate had a 70% reduction in false negative diagnoses and a 24% reduction in false positive diagnoses. This improvement was independent of diagnostic sub-specialization or years of experience of the pathologists and whether the analysis was done remotely or on-site. Furthermore, the study showed that non-specialist pathologists using Paige Prostate were as accurate as prostate specialists who were not using the software. The dataset included slides from over 150 institutions to ensure the system generalized to cases from different hospitals and different geographies.
“Pathologists examine biopsies of tissue suspected for diseases, such as prostate cancer, every day. Identifying areas of concern on the biopsy image can help pathologists make a diagnosis that informs the appropriate treatment,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “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.”
“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 standardize pathology diagnosis, expedite the diagnostic process, and provide pathologists and patients greater comfort from the added scrutiny of their pathology slides,” said David Klimstra, MD, Co-Founder and Chief Medical Officer at Paige.