A new artificial intelligence-powered cancer detection tool is under review by the Food and Drug Administration and could become the first device of its kind approved in the U.S., according to a Newsweek report.
The company behind the technology said it hopes to launch the tool next year if it receives regulatory clearance.
C the Signs is designed to help clinicians identify patients at risk of cancer by analyzing existing medical records, including physician notes, prescriptions and test results, without requiring additional scans or imaging. The goal is to detect cancer at an earlier and more treatable stage.
Dr. Bea Bakshi, co-founder and CEO of C the Signs, told Newsweek the company is pursuing FDA De Novo clearance, a pathway used for novel medical devices that do not have comparable products already on the market. Bakshi said the FDA indicated it had not identified a similar device, potentially making C the Signs the first approved product in its category.
Early Detection
The company said the technology is already used by more than 11,000 healthcare professionals across the U.K.’s National Health Service and has helped identify 75,000 cancer patients while reducing diagnostic timelines by 21%. Bakshi also said the company plans to include 250,000 Americans in a study this year.
According to Bakshi, the tool can review years of medical history in less than 60 seconds and identify subtle patterns that clinicians may miss. She said current screening programs cover only a small fraction of the more than 200 known cancer types and that many patients are missed during their first doctor’s visit.
The company said the platform has a 99% negative predictive value for identifying patients with cancer and a 94% accuracy rate in predicting tumor origin. Once a patient is flagged as high risk, clinicians can order additional testing and diagnostic assessments.
Expert Views
A Mayo Clinic validation study involving one million patient records across Arizona, Minnesota and Florida found that one in four cancer patients could be identified between one and five years before diagnosis, according to the company.
Anant Madabhushi, executive director of the Emory University Empathetic AI for Health Institute, told Newsweek the technology represents a promising direction for cancer care but said additional validation in U.S. populations remains necessary.
Harvard Medical School professor David Walt cautioned that AI-based cancer screening tools could generate false positives and unnecessary patient anxiety.
The development comes amid a broader push to improve cancer diagnosis and treatment. In May, Medicare expanded coverage for Personalis’ breast cancer monitoring test, while major drugmakers continued to invest heavily in oncology. Pfizer Inc. (NYSE:PFE) recently announced a cancer-drug collaboration worth up to $10.5 billion with Innovent Biologics.
Disclaimer: This content was produced with the help of AI tools and was reviewed and published by Benzinga editors.
Image via Shutterstock
Login to comment