Digital Pathology Solutions Provider Paige Receives FDA Grants Breakthrough Device Designation to Lymph Node Detection Software in Breast Cancer
10/30/23 (written by: Scott Gleason) Paige, a developer of digital pathology solutions and clinical AI applications, has announced the U.S Food and Drug Administration (FDA) has awarded Paige Lymph Node a Breakthrough Device Designation. The company’s Lymph Node product is for detecting metastases that have spread to the lymph nodes in breast cancer using digital pathology images and the software has demonstrated 97.7% sensitivity in detecting metastases. Paige Lymph Node is classified as an in vitro diagnostic medical device software. It has been developed using a deep learning model trained on an extensive dataset comprising over 32,000 digitized hematoxylin & eosin (H&E) lymph node slides. When reviewing lymph node tissue for possible cancer involvement, Paige Lymph Node identifies areas of concern for the pathologist’s further examination. This assistance makes the pathologist’s task more efficient and helps ensure a timely and accurate diagnosis. Additionally, studies have shown it increases pathology sensitivity by 25% for detecting micro-metastases and isolated tumor cells when compared to standard reads while improving total read time by 55%.
The Breakthrough Device Designation from the FDA is typically reserved for technologies that hold the promise of enhancing the diagnosis or treatment of life-threatening or debilitating diseases, particularly in cases where approved alternatives are lacking or where the new technology offers substantial advantages over existing alternatives. For patients diagnosed with breast cancer, the evaluation of lymph nodes is a crucial step in determining the prognosis and planning treatment. The application rapidly and accurately identifies even minuscule lymph node metastases, streamlining the diagnostic process and enhancing the management of breast cancer.
According to David S. Klimstra, M.D., Founder and Chief Medical Officer at Paige, “Paige Lymph Node uses the power of AI to help the pathologist identify even small lymph node metastases rapidly and accurately, ensuring that breast cancer patients receive the optimal management of their disease.”
Paige had previously achieved the breakthrough designation for another AI application, Paige Prostate Detect, designed for the identification of cancerous prostate tissue.