FDA Grants Paige Breakthrough Designation for AI Cancer Detection Across Sites
Paige, a leader in next-generation AI technology, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to Paige PanCancer Detect*. This AI-assisted diagnostic tool is designed to help pathologists detect potential cancerous areas across various tissues and organs. Notably, this is the first AI-enabled tool to receive such a designation for its ability to identify both common cancers and rare variants from multiple anatomic sites.
As the demand for pathology services continues to increase, the shortage of trained pathologists is becoming more pronounced. This growing gap between the need for diagnostic services and the availability of skilled professionals highlights the critical role of AI-powered tools like Paige PanCancer Detect in the future of cancer diagnostics. Paige PanCancer Detect, an advanced AI-assisted diagnostic application, helps close this gap by assisting pathologists in identifying cancer across a wide range of tissues and organs. This innovative tool not only boosts diagnostic confidence but also improves workflow efficiency, enabling quicker and more reliable results for patients.
Pathology labs manage a wide variety of case types, making it increasingly difficult for pathologists to keep up with the rising volume and complexity of diagnostic work. A multi-tissue AI application like Paige PanCancer Detect is essential in handling the growing workload effectively. By providing support across multiple tissue types, the AI application helps pathologists focus on the most critical cases, flagging potential discrepancies in diagnoses and thereby reducing the time to diagnosis. This not only results in faster care for patients but also enhances the accuracy of cancer detection, which is vital in delivering appropriate treatment in a timely manner.
Dr. David Klimstra, Co-Founder and former Chief Medical Officer at Paige, emphasized the transformative role of AI in cancer diagnostics. He stated, “The Breakthrough Device designation demonstrates the significance of AI in transforming cancer diagnostics. By aiding in the identification of cancerous cases 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 U.S. Food and Drug Administration (FDA) established the Breakthrough Devices Program to expedite the development and review of devices that offer more effective treatments or diagnostics for life-threatening or debilitating diseases. By granting Breakthrough Device designation to Paige PanCancer Detect, the FDA is signaling the potential of this AI tool to revolutionize cancer diagnostics and ensure that patients and healthcare providers have access to it more quickly. The designation facilitates faster development, assessment, and premarket approval, which ultimately improves patient outcomes by accelerating the availability of essential diagnostic tools.
Razik Yousfi, CEO and CTO of Paige, celebrated the achievement, noting, “We see this designation as another pivotal step in transforming cancer diagnostics. 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.”
Paige has a history of pioneering regulatory milestones in AI for pathology. The company previously secured Breakthrough Device designation for Paige Prostate Detect, an AI-powered application designed to assist in the detection of prostate cancer. This application later became the first FDA-authorized AI application in pathology. Paige also received Breakthrough Device designation for Paige Lymph Node, which identifies breast cancer metastases in lymph node tissue. Additionally, Paige FullFocus®, an AI-driven whole-slide image viewer, has been FDA-cleared for primary diagnostic use.
The Breakthrough Device designation for Paige PanCancer Detect represents a significant milestone in the company’s mission to advance precision medicine. By equipping pathologists with advanced AI tools, Paige is enabling them to meet the evolving challenges of cancer diagnostics. Paige PanCancer Detect is available within the Paige Alba™ platform, as well as through partner digital pathology platforms, and has the potential to become an essential tool for pathologists dealing with a growing patient load.
It is important to note that Paige PanCancer Detect is currently for Research Use Only (RUO) and is not intended for use in diagnostic procedures. Nonetheless, its breakthrough potential is recognized in the field of cancer research, where it aids in detecting cancers across multiple tissue types and identifying rare cancer variants, which can be difficult to detect with traditional methods.
Paige’s expertise in AI-driven solutions extends beyond cancer detection and diagnosis. The company leverages exclusive access to millions of digitized pathology slides, clinical reports, and genomic data to build a comprehensive understanding of cancer. This holistic approach takes into account diverse factors such as gender, race, ethnicity, and geographical regions, enabling Paige to create advanced AI models that redefine how cancer is detected, diagnosed, and treated. With its AI solutions, Paige is setting new standards in precision diagnostics and continues to lead the way in uncovering novel insights that transform the treatment of cancer.
In conclusion, Paige’s AI applications are revolutionizing the field of cancer diagnostics. With the FDA’s Breakthrough Device designation for Paige PanCancer Detect, the company has taken another significant step forward in advancing patient care. As the demand for pathology services grows, AI-powered tools like Paige PanCancer Detect will play an increasingly vital role in ensuring timely, accurate, and efficient cancer diagnosis, ultimately improving patient outcomes and shaping the future of cancer care.
