MSKCC-backed digital pathology startup nets FDA breakthrough device designation

Digital pathology startup Paige.AI has received a breakthrough device designation from the FDA for its use of artificial intelligence in the diagnosis of cancer.

Built off a data set of four years’ worth of scanned pathology slides exclusively licensed from Memorial Sloan Kettering Cancer Center—plus the work of Paige.AI’s co-founder and chief scientific officer, Thomas Fuchs, Dr.Sc., director MSKCC’s computational pathology lab—the startup aims to deliver a series of organ-specific AI products that can help scale up cancer pathology work while keeping costs low.

Paige.AI is also funding the digitization of more than 4 million additional slides from MSKCC’s archives, with the goal of integrating computational pathology into treatment models alongside electronic health records and genomic and clinical data.

According to the New York-based company, the FDA’s designation is a first for the use of AI in cancer diagnosis. Currently, the PAIGE platform, which stands for Pathology Artificial Intelligence Guidance Engine, includes a universal slide viewer that has been used across MSKCC since 2017. Paige.AI was launched in February 2018 with $25 million in venture capital.

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“We are thrilled to receive Breakthrough designation and look forward to collaborating with the FDA to bring our products to market, starting with prostate cancer and expanding from there,” said Paige.AI CEO Leo Grady, Ph.D., in a statement.

Grady joined Paige.AI as CEO last month, after serving as senior VP of engineering for medtech company HeartFlow.

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“We have a rare opportunity at Paige.AI to provide technology that helps doctors achieve the triple aim of healthcare: improved patient care, improved patient experience and lowered costs,” Grady said in a release at the time.

The launch of a for-profit venture from MSKCC raised some concerns over the institution’s commercial use of decades of patient health data, as well as additional financial conflicts-of-interest, according to a report last September from The New York Times and ProPublica, which said that MSKCC received a 9% share in Paige.AI in return for access to its database of digital pathology slides.