PHILADELPHIA, PA — Proscia received a new U.S. Food and Drug Administration 510(k) clearance for its Concentriq AP-Dx digital pathology platform, expanding scanner compatibility and giving the company a regulatory pathway to add supported hardware and image formats without submitting a new 510(k) for each change.
The clearance adds compatibility with Leica’s Aperio GT 450 DX slide scanner and permits cloud deployment of Concentriq AP-Dx, which is used by laboratories for primary diagnosis.
It also includes a Predetermined Change Control Plan, or PCCP, allowing Proscia to validate and implement support for additional FDA-cleared scanners, image formats and displays under an established regulatory framework.
That structure could make it easier for laboratories to expand digital pathology systems over time without being locked into a single scanner or proprietary technology ecosystem.
“The PCCP helps us to protect that investment, giving customers confidence that Concentriq AP-Dx will continue to be an interoperable foundation as their needs evolve,” Ian Cadieux, Proscia’s head of quality and regulatory, stated.
Concentriq AP-Dx first received FDA 510(k) clearance for primary diagnosis in February 2024 with Hamamatsu’s NanoZoomer S360MD slide scanner. The platform is also CE-marked under the European Union’s In Vitro Diagnostic Regulation.
Proscia is positioning interoperability as an increasingly important issue for pathology laboratories as cancer diagnostic demand grows and the pathologist workforce contracts.
The company cited projections that more than 2.1 million Americans will be diagnosed with cancer this year, increasing pressure on laboratories to process higher case volumes.
Proscia also pointed to KLAS Research’s Digital Pathology 2026 report, in which the company received the highest score for supporting customer integration goals and the highest overall performance score based on customer feedback.
Proscia reports that diagnostic laboratories using its technology collectively manage about 12 million patient cases annually. The company also serves 16 of the world’s 20 largest pharmaceutical companies.
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