U.S. FDA Grants Paige Breakthrough Device Designation for AI Application that Detects Cancer Across Different Anatomic Sites

Paige, a leader in next-generation AI technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect*, an AI-assisted diagnostic application intended to assist pathologists in the detection of foci that are suspicious for cancer from multiple tissues and organs. This marks the first designation of its kind for an AI-enabled tool capable of identifying both common cancers and rare variants from different anatomic sites.

As the demand for pathology services continues to grow at a pace faster than the supply of trained pathologists, AI-powered tools like Paige PanCancer Detect are becoming essential in closing this widening gap. Pathology labs handle highly variable case types, and only a multi-tissue application can effectively support the growing diagnostic workload. By assisting in the detection of cancer across a broad range of tissues and organs, this innovative AI application helps enhance diagnostic confidence1, streamline workflows, and deliver reliable results to patients more quickly.

“The Breakthrough Device designation demonstrates the significance of AI in transforming cancer diagnostics,” said Dr. David Klimstra, Co-Founder and former Chief Medical Officer of the company. “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.”

The FDA established the Breakthrough Devices Program as a voluntary mechanism for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients and health care providers with timely access to medical devices by speeding up development, assessment, and review for premarket approval and marketing authorization.

“We see this designation as another pivotal step in transforming cancer diagnostics,” said Razik Yousfi, CEO and CTO of the company. “The company 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.”

The company has a strong history of regulatory firsts in AI for pathology. The company previously secured Breakthrough Device designation for Paige Prostate Detect2, an AI-powered application that aids in the detection of prostate cancer, which later became the first FDA-authorized AI application in pathology. Paige also received Breakthrough Device designation for Paige Lymph Node, designed to identify breast cancer metastases in lymph node tissue. Additionally, Paige FullFocus®, a whole-slide image viewer, is FDA-cleared for primary diagnosis3.

The Breakthrough Device designation for Paige PanCancer Detect represents a significant milestone in the company’s mission to advance precision medicine and equip pathologists with the tools they need to meet the evolving demands of cancer diagnostics. Paige PanCancer Detect is available within Paige Alba™, the Paige Platform, and our partner digital pathology platforms.

^*Paige PanCancer Detect is for Research Use Only (RUO). Not for use in diagnostic procedures.
¹Rienda, I., Vale, J., Pinto, J. et al. Using artificial intelligence to prioritize pathology samples: report of a test drive. Virchows Arch (2024). https://doi.org/10.1007/s00428-024-03988-1
²In the United States, Paige Prostate Detect (DEN200080) approved for clinical use
³510(k) Device Number: K241273 & 510(k) Device Number: K201005