New Cancer Risk Tool Under FDA Review Aims to Improve Early Detection in the U.S.
A new medical device designed to identify early cancer risk in patients is currently under review by the Food and Drug Administration (FDA), with plans to make it available to Americans next year. Developed by C the Signs, the tool assists clinicians in examining patient medical records to detect cancer risk without needing further tests or imaging. This aims to facilitate early-stage referrals for potentially treatable cancer cases.
UK Adoption and Success
Currently, the tool is utilized by over 11,000 healthcare professionals within the United Kingdom’s National Health Service (NHS). To date, it has helped detect cancer in 75,000 patients and decreased diagnostic timelines by 21 percent. Dr. Bea Bakshi, co-founder and CEO of C the Signs, noted that since the FDA found no similar products on the market, the device is being reviewed for a De Novo classification, designated for innovative low-to-moderate-risk devices with no established precedent.
Planned U.S. Study and FDA Status
The company plans to offer 250,000 Americans access to the tool this year as part of a study. An HHS spokesperson, when asked about the tool, indicated that the FDA generally does not confirm or discuss applications unless the product has been publicly disclosed by its sponsor.
How the Tool Functions
Bakshi explained that traditional cancer screening in the U.S. and the U.K. covers only a few of the over 200 cancer types, often leading to delayed diagnoses. The device assesses a patient’s medical history, identifying important patterns over time, such as gradual increases in specific white blood cells over several years. These changes might signal early cancer risk before symptoms become apparent.
The device effectively screens each cancer type using tailored models, achieving a 99 percent negative predictive value for detecting cancer and a 94 percent accuracy in predicting tumor origin. If the tool identifies a cancer risk, clinicians are usually prompted to follow its recommendations for further diagnosis and testing.
Impact on U.S. Healthcare Costs and Early Detection
Gregory Simon, a C the Signs U.S. advisor and former executive director of the White House Cancer Moonshot Task Force, believes the tool offers earlier, more accurate detection than other tests and is more affordable, potentially reducing healthcare costs and saving lives. He acknowledged that introducing C the Signs in the U.S. involves complexity due to the multi-payer system but recommended targeting early adopters and pursuing consumer marketing.
Expert Opinions
Experts like Anant Madabhushi from the Emory University Empathetic AI for Health Institute view C the Signs as a promising tool for cancer care, particularly in communities with limited specialist access. He stressed the importance of validating the tool in U.S. populations given the differences from NHS settings.
A Mayo Clinic study validated the tool’s effectiveness with U.S. populations, showing it could identify at-risk patients ahead of clinical diagnoses. However, concerns remain about the potential for false positives and the psychological stress they might cause, as noted by Harvard Medical School professor David Walt.