New chapter for Paige as FDA approves prostate cancer software

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Paige has added to its regulatory approvals for its AI-based diagnostics platform with an FDA de novo clearance for Paige Prostate. The green light was based on a study comparing the performance of pathologists with the software in identifying prostate cancer on biopsy slides. Pathologists were asked to do two reads of slides, with and without Paige Prostate; using the software improved detection rates by 7.3%. However, this was offset by more false positives, at 6.7% compared with 1.4% for pathologists. In granting approval the FDA said this risk was mitigated by professionals using Paige Prostate as an adjunct to diagnoses. The FDA win follows a CE mark in Europe in December 2020 for Paige’s prostate offering, and its breast cancer screening tool Paige Breast. These approvals will help validate Paige’s technology, but the more interesting advancement is their integration into other parts of the healthcare system. Paige has already teamed up with Agendia, a breast cancer diagnostic company, to develop cloud-based digital testing for early diagnosis and treatment planning. Investors are clearly sensing potential here, as the New York-based group has raised more than $200m in venture funding since its formation in 2017.

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