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A female clinician examines the lymph nodes in a woman's armpit.
The application detects the presence of breast cancer metastases with 98 percent sensitivity as demonstrated in a clinical study.
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Breast Cancer Detection App Gets FDA's Breakthrough Device Designation

The application is the first of its kind to be recognized by the FDA

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Swathi Kodaikal, MSc
Photo portrait of swathi kodaikal

Swathi Kodaikal, MSc, holds a master’s degree in biotechnology and has worked in places where actual science and research happen. Blending her love for writing with science, Swathi enjoys demystifying complex research findings for readers from all walks of life. On the days she doesn’t write, she learns and performs Kathak, sings, makes plans to travel, and obsesses over cleanliness.

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Published:Nov 03, 2023
|1 min read
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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Paige Breast Lymph Node, an AI application that detects breast cancer metastases of any size in lymph node tissues.

Determining if the cancer has spread to a patient’s lymph nodes helps clinicians find the best and most effective treatment. “Paige Breast 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,” said David S. Klimstra, MD, founder and chief medical officer at Paige, in a recent press release.

How does the AI-based application work?

Paige Breast Lymph Node is an in vitro diagnostic medical device software, whose deep learning model has been trained with over 32,000 digitized hematoxylin & eosin (H&E) lymph node slides. The application detects the presence of breast cancer metastases with 98 percent sensitivity, as shown in an investigational clinical study involving three pathologists and data from 148 patients. 

If a tissue is suspected of being cancerous, the application highlights each area of concern for further review, helping pathologists quickly and efficiently assess and reach a diagnosis.

“We are thrilled with the decision from the FDA to recognize the importance of AI in managing metastatic disease in breast cancer patients,” said Andy Moye, PhD, the CEO of Paige, in the press release. “The Paige Breast Lymph Node algorithm saves pathologists time and provides critical information for pathologists to support their diagnosis amidst unprecedented demands and resource constraints.” 

In the United States, Paige Lymph Node is for research use only and should not be used in diagnostic procedures.