FDA Authorizes Software that Can Help Identify Prostate Cancer

Cancer that starts in the prostate is called prostate cancer. According to the Centers for Disease Control and Prevention, aside from non-melanoma skin cancer, prostate cancer is the most common cancer among men in the United States. It is also one of the leading causes of cancer death among men.

Paige Prostate is compatible for use with slide images that have been digitized using a scanner. The digitized slide image can then be visualized using a slide image viewer.

The Food and Drug Administration 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.

Potential risks include false negative and false positive results, which is mitigated by the device's use as an adjunct (e.g., the device assists pathologists reviewing slide images) and by the professional evaluation by a qualified pathologist who takes into account patient history among other relevant clinical information, and who may perform additional laboratory studies on the samples prior to rendering a final diagnosis.

The Food and Drug Administration reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. Along with this authorization, the FDA is establishing special controls for devices of this type, including requirements related to labeling and performance testing. When met, the special controls, along with general controls, provide reasonable assurance of safety and effectiveness for devices of this type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA's 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.