Paige.AI Files for IPO Following FDA Breakthrough Device Designation for Its AI-Powered Cancer Diagnostic Platform

VCBeat (WeChat Official Account: vcbeat) has learned that Paige.AI, a digital pathology startup headquartered in New York, USA, recently received the U.S. Food and Drug Administration’s (FDA) “Breakthrough Device” designation for its use of artificial intelligence in cancer diagnosis.

Paige.AI was founded in 2017 and completed a $25 million Series A financing round on February 6, 2018. According to the company, this marks the first time the FDA has approved the use of artificial intelligence for cancer diagnosis.

Paige.AI’s AI-powered cancer diagnostics are built upon a dataset derived from the research of Dr. Thomas Fuchs, co-founder and Chief Scientific Officer of Paige.AI. This dataset comprises four years of pathological slide scans, exclusively licensed by Memorial Sloan Kettering Cancer Center (MSKCC). The startup Paige.AI aims to launch a suite of AI-based products targeting various human organs, helping to scale cancer pathology workflows while maintaining low operational costs.

Paige.AI also funded the digitization of more than 4 million additional slides from the MSKCC archives, with the goal of integrating computational pathology with electronic health records and genomic and clinical data into treatment models; in return, MSKCC will receive a 9% stake in Paige.AI.

Dr. Leo Grady, CEO of Paige.AI, stated in a press release, “We are thrilled to achieve this breakthrough and look forward to collaborating with the FDA to bring our products to market. Our cancer diagnostics platform will launch with prostate cancer diagnosis and expand from there.” Grady brings extensive experience to his role, having joined Paige.AI as CEO in February 2019 after serving as Senior Vice President of Engineering at the medical technology company HeartFlow.

“Paige.AI has provided us with invaluable technical support, holding the promise of helping physicians achieve the Triple Aim of healthcare: improving patient care, enhancing patient experience, and reducing care costs,” said Leo Grady in a press release.

Paige.AI is an emerging company leveraging artificial intelligence to combat cancer, with Paige standing for Pathology Artificial Intelligence Guidance Engine.

Paige.AI stated that the company currently plans to initially focus on the diagnosis of breast cancer, prostate cancer, and other major cancers, and hopes to collaborate with medical centers beyond MSK, commercial laboratories, and pharmaceutical companies in the course of developing and expanding its applications.

Paige.AI’s team consists of machine learning experts with a decade of experience in building large-scale ML systems for computational pathology. They have developed novel deep learning and ensemble models, creating the first clinical-grade artificial intelligence for pathology.

(Compiled by Ning Chen)