New Cancer Risk Tool That Flags Patients Early Seeks FDA Approval
A new tool that identifies early cancer risk in patients is currently under review with the Food and Drug Administration (FDA), the company that developed the device informed Newsweek, and they hope to have the tool rolled out to Americans next year.
C the Signs is a medical device that helps clinicians analyze patient medical records to determine whether they are at risk of developing cancer without them needed to do any additional tests or imaging. The aim is to refer patients at risk of cancer at the earliest and most treatable stage of the disease.
UK’s NHS Already Using Tool
It is currently used by over 11,000 healthcare professionals in the United Kingdom’s National Health Service, the NHS, and to date, 75,000 patients with cancer have been detected by the tool. It has also been found to reduce diagnostic timelines by 21 percent.
Dr. Bea Bakshi, co-founder and CEO of C the Signs, told Newsweek that as the FDA informed them it had not found a product like C the Signs on the market before, they had been able to pursue a De Novo classification, specifically used for novel low-to-moderate-risk devices with no predicate, meaning it could be the first medical device of its kind approved in the U.S.
While C the Signs is under review with the FDA, the company is also planning on giving 250,000 Americans a chance to use the tool this year as part of a study, Bakshi said.
When approached for comment about the tool, a Department of Health and Human Services (HHS) spokesperson told Newsweek that the FDA “generally cannot confirm or deny the existence of a pending product application that has not been previously been publicly disclosed by the sponsor, or discuss the status of a pending application.”
How Does the Tool Work?
Bakshi told Newsweek that cancer screening, both in the U.S. and the U.K., only covers a small number of the more than 200 types of cancer that exist, leaving many patients having to embark on a “convoluted journey” to obtain a diagnosis, often having multiple appointments, and even potentially ending up in the emergency department, before the diagnosis is given.
In less than 60 seconds, the device scans a patient’s medical history, everything from consultation notes to past prescriptions, and picks up crucial patterns over the years from previous testing-trends a clinician could easily miss.
These changes could be gradual increases in certain types of white blood cells across years of blood tests, for example. While each individual test may be within what is considered a normal range, a steady increase could, in some cases, indicate early cancer risk.
“All of those data points tell a story which gives us really early signs and signals," Bakshi said.
“Because of just how hard it is to detect cancer, most people get missed,” Bakshi added. She said around one in two people will "get missed at that first appointment when they see a doctor.”
She said that C the Signs therefore “takes that guesswork out of it,” and for “every single patient on that first encounter, we identify and get them into the right pathway at the right time.”
It also means that a patient’s cancer risk is flagged before they get to a stage where they have the usual “red flags” that suggest cancer may be present, which typically mean it has developed to a later, more serious stage-for example, in the case of breast cancer, when a lump or changes to the breast are noticed by a patient, Bakshi explained.
The device also has a different model for each cancer type, so the technology is able to screen more accurately for each individual type of cancer. It has a 99 percent negative predictive value for identifying patients with cancer, and a 94 percent accuracy rate in predicting tumor origin.
Once the assessment is completed, if a patient is identified as having a risk of cancer, most clinicians will then act on the recommendation, Bakshi said, and diagnostic assessments and testing will take place.
The company provided Newsweek with testimonials from patients and clinicians, all of whom were complimentary about their experience with the device, praising how it sped up the diagnostic process.
How It Could Help Cancer Detection in the US
“The cost of cancer care is bankrupting both cancer patients and the U.S. healthcare system at every level,” Gregory Simon, C the Signs’ U.S. adviser, who was also executive director of the White House Cancer Moonshot Task Force under Joe Biden, told Newsweek.
He added that C the Signs “provides early, accurate detection of more cancers than other tests on the market” and is “vastly less expensive and makes screening as easy as possible.”
“This will lower cancer care costs and most importantly save many lives,” he said. “In many regions of the world, early detection is the only way to treat cancer because late-stage therapies are unavailable or priced out of reach.”
When asked what a U.S. rollout of C the Signs would like, Simon said that, as they have a “multipayer system,” a national rollout would be “very complicated.”
This means that he believed C the Signs should look for “early adopters in the cancer ecosystem who will implement it system-wide to prove its worth, which can then lead to Medicare and Medicaid adoption.”
He added that at the same time, direct to consumer marketing should also be “pursued given the test’s low cost and the opportunity to lower cancer deaths and suffering.”
What Do Experts Think?
Anant Madabhushi, executive director for the Emory University Empathetic AI for Health Institute, told Newsweek that he believed C the Signs represented a "genuinely promising direction for cancer care, and I think the underlying premise is sound."
"For American patients, the potential value is real," he said. "The U.S. primary care system is under significant capacity pressure, and a tool that passively and continuously screens the existing [Electronic Health Records (EHR)] for cancer risk signals-without requiring additional tests, imaging, or patient visits-could meaningfully extend a clinician’s reach, particularly in underserved communities where access to specialist care is limited."
However, he said that there are a few things that "warrant attention." He said that validation in U.S. populations is "essential, not just a regulatory formality-the demographics, comorbidity profiles, EHR documentation practices, and care pathways in the U.S. differ meaningfully from NHS settings."
Mayo Clinic Study Backs Tool
Bakshi shared with Newsweek that one Mayo Clinic study had validated its effectiveness on U.S. populations. The study reviewed the records of 1 million patients across Arizona, Minnesota and Florida, and showed that, by using C the Signs, one in four patients could be identified between 12 months to five years before the physician’s diagnosis date.
Madabhushi also said he would want to see the performance metrics "replicated in diverse American cohorts before widespread deployment," and that any artificial intelligence-based risk-flagging tool "must be paired with clear clinical workflows for follow-up; a high-sensitivity alert is only as valuable as the system’s ability to act on it equitably and promptly."
Overall, he said he was "cautiously optimistic," adding that "if the U.S. validation data are robust and the FDA De Novo process is navigated rigorously, this class of tool has genuine potential to move the needle on early detection at population scale."
One expert, however, told Newsweek they weren't certain about the technology's benefits. David Walt, a professor of biologically inspired engineering at Harvard Medical School, said that there are many other AI systems using a similar approach to C the Signs.
"I'm not sure providing individuals with continuous updates on their cancer risk is the best approach for implementation," he said, adding that there will likely be "many false positives," which will mean "people who receive notice that their cancer risk has gone up will demand additional testing and will experience unnecessary psychological stress."
2026 NEWSWEEK DIGITAL LLC.
This story was originally published June 9, 2026 at 5:30 AM.