Digital pathology and clinical AI firm Paige has announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device designation for Paige Lymph Node, an AI application used to detect breast cancer metastases in lymph node tissue. Paige Lymph Node is the first AI application of its kind to receive such designation from the FDA.
The FDA’s Breakthrough Device designation is granted for technologies that have the potential to provide for more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. For these technologies, timely availability is in the best interest of patients because no approved alternative exists or because the technology offers significant advantages over existing approved alternatives.
“Pathologic assessment of lymph nodes in breast cancer patients is critically important for prediction of outcome and treatment, yet the process is time consuming and error prone,” said David S Klimstra, MD, 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 Lymph Node is an in vitro diagnostic medical device software, derived from a deep learning model that has been trained with over 32,000 digitized hematoxylin and eosin (H&E) lymph node slides. Paige Lymph Node detects the presence of breast cancer metastases with near-perfect sensitivity. If the lymph node tissue is suspicious for cancer, Paige Lymph Node will highlight each area of concern for further review by the pathologist, making it easier and more efficient for them to assess and reach a diagnosis.
“We are thrilled with the decision from the FDA to recognise the importance of AI in managing metastatic disease in breast cancer patients,” said Andy Moye, PhD, CEO of Paige. “The Paige Lymph Node algorithm saves pathologists time and provides critical information for pathologists to support their diagnosis amidst unprecedented demands and resource constraints.”
Paige previously achieved breakthrough designation for Paige Prostate Detect, an AI application designed to assist in the identification of cancerous prostate tissue, before earning the distinction of becoming the first and only FDA-authorised digital pathology application to date. Paige FullFocus, a whole-slide image viewer, has also been approved by the FDA for use in primary diagnosis.