Digital Pathology Focuses on Forward Push Amid Regulatory Uncertainty

Digital pathology continues to generate industry buzz, especially with numerous heavy hitters like Aperio, Olympus, and Bioimagene displaying a significant presence at this week’s CAP ’10 meeting. Standardization is also moving forward with the recent release of the medical image exchange standard Supplement 145 from The Digital Imaging and Communications in Medicine (DICOM) Standards Committee, of which the CAP is a member.

However, while there are over a dozen FDA 510(k) clearances for digital analysis of immunohistochemistry procedures, the waiting game continues for how the agency wants to regulate digitalization of hematoxylin and eosin (H&E) slides using whole slide imagng (WSI) systems, according to Steve Potts, PhD, CEO of digital pathology service provider Flagship Biosciences (Flagstaff, AZ). Potts recently spoke at a histology image analysis webinar on regulation and digital pathology hosted by Denver-based Digital Pathology Consultants.

There has been no word from the FDA since October 2009, when stakeholders—including the CAP and digital pathology companies—testified before the agency’s Hematology and Pathology Devices Advisory Committee during a public comment period to address oversight of whole slide imagining (WSI) systems.

One key issue is whether these systems should be subjected to the agency’s Class II or Class III requirements. While Class II products are frequently “cleared” by the 510(k) process, Class III devices must go through the PMA process. This process requires more investment—both in money and time—as the device has to be “approved” as safe and effective after undergoing clinical trials. The CAP testified at the hearing, primarily on recommendations for validating WSI systems.

Dr. Potts speculates that WSI will likely be considered Class II devices and will need to be cleared by the FDA. He added that subsequent pathology procedures using this device will then be considered laboratory developed tests (LDTs), as the regulatory filings will likely be for specific applications. However, this could further delay momentum, as the FDA is currently crafting LDT oversight framework.

Nevertheless, Dr. Potts believes that once these regulatory barriers are negotiated, digital pathology will move ahead at breakneck speed. “When this technology starts to move into labs and pathology practices, it will come fast,” he predicted.