Paige Wins FDA Breakthrough Nod for AI-Powered PanCancer Detect

Paige, a company specializing in next-generation artificial intelligence (AI) technology, has been granted U.S. Food and Drug Administration (FDA) breakthrough device status for Paige PanCancer Detect, an AI-assisted diagnostic application to assist pathologists in detecting foci that are suspicious for cancer across a wide range of tissue for multiple organs.

According to the company, this marks the first designation of its kind for an AI-powered tool capable of identifying both common cancers and rare variants from different anatomic sites.

AI-powered tools like Paige PanCancer Detect are becoming essential in closing the gap between the demand for pathology services and supply of trained pathologists. Pathology labs handle highly variable cases, and only a multi-tissue application can effectively support the growing diagnostic workload.

“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.”

The company previously won breakthrough status for Paige Prostate Detect, an AI-powered application that aids in the detection of prostate cancer. It later became the first FDA-authorized AI application in pathology.

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The company also received breakthrough designation for Paige Lymph Node, designed to spot 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.”