Paige, a leader in next-generation artificial intelligence technology for pathology, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to its PanCancer Detect application. This AI-assisted diagnostic tool is designed to help pathologists identify suspicious cancer foci across multiple tissue types and organs, marking the first such designation for an AI solution capable of detecting both common cancers and rare variants from different anatomic sites.
The designation comes at a critical time when pathology services face increasing demand amid a shortage of trained pathologists. By assisting in cancer detection across a broad range of tissues, PanCancer Detect aims to enhance diagnostic confidence, streamline workflows, and deliver faster results to patients.
"The Breakthrough Device designation demonstrates the significance of AI in transforming cancer diagnostics," said Dr. David Klimstra, Co-Founder and former Chief Medical Officer at Paige. "By aiding in the identification of cases with cancer and flagging potential diagnostic discrepancies, Paige PanCancer Detect can help pathologists focus on the most critical cases and reduce time to diagnosis, leading to faster results for patients."
Expanding Regulatory Portfolio
In addition to the Breakthrough Device designation, Paige recently announced that its FullFocus digital pathology image viewer received FDA 510(k) clearance for use with two additional digital pathology scanners: the Leica Aperio GT 450 DX scanner (supporting SVS and DICOM file formats) and the Hamamatsu NanoZoomer S360MD Slide scanner system (supporting NDPI file format).
This new clearance complements Paige's previous authorization for use with the Philips IntelliSite Pathology Solution Ultra Fast Scanner, making FullFocus one of the most compatible digital pathology platforms available in the market.
"We are pleased that Paige's FullFocus digital slide viewer is now FDA cleared for clinical use with the NanoZoomer S360MD Slide scanner system," said James Butler, VP of Marketing at Hamamatsu. "This clearance further demonstrates the ongoing effort across the industry to provide pathology labs with seamless integration of best-in-class solutions, helping to accelerate the adoption of digital pathology and drive improved clinical workflows."
Addressing Critical Pathology Challenges
The FDA's Breakthrough Devices Program is designed to accelerate the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating conditions. For pathology specifically, this designation acknowledges the potential impact of AI tools in addressing workforce shortages and diagnostic challenges.
Pathology labs today handle highly variable case types, and only multi-tissue applications like PanCancer Detect can effectively support the growing diagnostic workload. The technology is designed to flag potential cancer cases for pathologist review, potentially reducing diagnostic time and improving accuracy.
Building on a History of Regulatory Firsts
Paige has established itself as a pioneer in securing regulatory approvals for AI-powered pathology tools. The company previously received Breakthrough Device designation for Paige Prostate Detect, which later became the first FDA-authorized AI application in pathology. Paige also secured Breakthrough designation for Paige Lymph Node, designed to identify breast cancer metastases in lymph node tissue.
"We see this designation as another pivotal step in transforming cancer diagnostics," said Razik Yousfi, CEO and CTO of Paige. "Paige remains committed to developing AI solutions that not only drive innovation but also meet the highest regulatory standards. This achievement underscores our continued leadership in building clinical applications that establish a new benchmark for regulatory excellence—advancing patient care and shaping the future of pathology."
Technology Foundation and Approach
Paige's AI solutions are built on a comprehensive foundation of data, including millions of digitized pathology slides, clinical reports, and genomic information. This diverse dataset encompasses factors such as gender, race, ethnicity, and geographical regions, enabling the company to develop AI solutions with broad applicability.
The company has also developed what it describes as the first million-slide foundation model for cancer, positioning it at the forefront of AI development in pathology. This extensive training allows Paige's algorithms to recognize patterns across different tissue types and cancer presentations.
Future Implications for Digital Pathology
While Paige PanCancer Detect is currently available for Research Use Only and not yet approved for diagnostic procedures, the Breakthrough Device designation suggests a potentially accelerated pathway to clinical implementation. The technology is available within Paige Alba, the company's platform, as well as through partner digital pathology platforms.
As digital pathology adoption continues to grow, AI-assisted tools like PanCancer Detect could play an increasingly important role in managing workflow, prioritizing cases, and supporting pathologists in delivering accurate and timely diagnoses. The technology represents a significant step toward the broader integration of AI in cancer diagnostics and precision medicine.
