Tech companies have been looking for years to develop artificial intelligence that can help diagnose cancer — and now one company has a license from the U.S. Food and Drug Administration (FDA). For the first time, the FDA approved the Paige.AI's Artificial Intelligence Program for Cancer Diagnostics, a New York-based company that was launched in 2018 using data and digital pathology technology from Memorial Sloan Kettering Cancer Center. The company's product "Paige Prostate" analyzed images from prostate tissue biopsy reports to find signs of malignant cells.
The software highlights the areas most likely to contain cancer in a standard prostate biopsy image and labels them for further review by trained professionals.
David Klimstra, co-founder and chief medical officer of Paige.AI, said in a statement: "This landmark APPROVAL BY THE FDA of Paige Prostate marks the beginning of a new era of computer-aided diagnostics for pathology. ”
Klimstra added that the product paves the way for "the many tools of the future" that can help standardize and speed up pathological diagnosis, and that it debuted at a critical moment.
Paige.AI said it is imperative to improve the efficiency of diagnostic workloads, which are growing rapidly. The company expects global cancer cases to increase by 60 percent over the next 20 years — and the number of pathologists available isn't expected to keep up.
Tim Stenzel, director of the FDA's Office of In Vitro Diagnostics, said: "The authorization of this AI-based software could help increase the number of prostate biopsy samples that identify cancer tissue, which could ultimately save lives." ”
The prostate-focused software has won a new license, based in part on a clinical study evaluating the use of the procedure by 16 pathologists. Everyone was evaluated for mixed slices of cancer and benign tissue, with or without the help of Paige Prostate. The samples came from more than 150 institutions to test ai's ability to work in different hospitals and geographies.
While a patient's final diagnosis may be based on multiple biopsies and other examination information, AI procedures do help increase overall cancer detection rates by an average of 7.3 percent. The software also helped reduce the number of false-negative diagnoses by 70% and the number of false-positive diagnoses by 24%.
Paige Prostate received CE certification for use in Europe last year, as did Paige.AI products that target breast cancer, although the latter is currently only used in research in the United States.
Earlier this year, Paige.AI raised $100 million in venture capital to help grow the company's software engineering and commercial teams. It's also working with companies like Philips and Perspectiveum to combine its ARTIFICIAL intelligence with digital pathology and diagnostic tools.