Paige Lymph Node Earns FDA Breakthrough Device Designation in Breast Cancer

It is believed that Paige Breast Lymph Node can efficiently detect suspicious areas of potential breast cancer metastasis, identify breast cancer micro-metastases and isolated tumor cells in lymph node tissue, and enhance diagnostic accuracy and confidence.

The FDA has granted breakthrough device designation to the artificial intelligence (AI)–based tool Paige Lymph Node for detecting breast cancer metastases in lymph node tissues, according to a press release from Paige.¹

Breakthrough therapy designation is given to technologies that may be able to provide more effective diagnoses or treatment for debilitating or life-threatening diseases.

Developers designed Paige Lymph Node as an in vitro diagnostic software informed by more than 32,000 digitized hematoxylin and eosin lymph node slides. The application works to detect breast cancer metastases by highlighting lymph node tissues that may be suspicious for cancer, helping pathologists to evaluate a patient’s disease more efficiently.

“Pathologic assessment of lymph nodes in patients [with breast cancer] is critically important for prediction of outcome and treatment, yet the process is time-consuming and error prone,” David S. Klimstra, MD, founder and chief medical officer at Paige, said in the press release.¹ “Paige Lymph Node uses the power of AI to help the pathologist identify even small lymph node metastases rapidly and accurately, ensuring that patients [with breast cancer] receive the optimal management of their disease.”

According to its developers, Paige Breast Lymph Node has demonstrated over 98% sensitivity when detecting metastases of any size.² Results with the AI tool are delivered via FullFocus, Paige’s clinical-grade viewer, which works with data encompassing pre-analytical variations, staining techniques, and scanners so that pathologists may deliver results quickly and accurately. It is believed that Paige Breast Lymph Node can efficiently detect suspicious areas of potential breast cancer metastasis, identify breast cancer micro-metastases and isolated tumor cells in lymph node tissue, and enhance diagnostic accuracy and confidence.

Developers announced the launch of their enhanced Paige Breast Suite in June 2023.³ In addition to Paige Breast Lymph Node, the suite included Paige Breast Detect, Paige Breast Neoplasm, Paige Breast Mitosis, and HER2Complete, which were all designed to streamline the day-to-day workflows of pathologists with respect to breast cancer diagnosis.

“With the addition of Neoplasm and Mitosis detection to our Breast Suite, we assist pathologists in gaining greater efficiency and confidence in everyday tasks like mitotic counting,” Klimstra said in a press release at the time of the Breast Suite expansion.³ “There are too few pathologists for the increasing demands of breast cancer diagnosis. Paige tackles the pathologist shortage by supporting breast cancer diagnosis and simultaneously providing greater confidence, reducing false negatives and increasing pathologists’ efficiency.”

The FDA previously approved the AI-based software Paige Prostate to identify areas of interest on prostate biopsy images that may harbor cancer for further review via pathologist in September 2021.⁴ According to findings from a clinical study, Paige Prostate yielded a 7.3% average improvement in cancer detection on individual slide images compared with unassisted pathologist reads.

References

1. U.S. FDA grants Paige breakthrough device designation for cancer detection in breast lymph nodes. News release. Paige. October 26, 2023. Accessed October 27, 2023. https://shorturl.at/bsuZ4
2. Introducing Paige Breast Lymph Node. Paige. 2023. Accessed October 27, 2023. https://info.paige.ai/breast
3. Paige applies the power of AI to improve breast cancer diagnoses with the launch of its expanded breast suite. News release. Paige. June 15, 2023. Accessed October 27, 2023. https://rb.gy/ew3ej
4. FDA authorizes software that can help identify prostate cancer. News release. FDA. September 21, 2021. Accessed October 27, 2023. https://rb.gy/to2xw