A new way to screen for breast cancer, the second most common cancer among women in the U.S., was recently authorized by the U.S. Food and Drug Administration. It’s technology that uses artificial intelligence to identify breast cancer risks called Clairity Breast.
According to an exclusive from TODAY, this technology is the “first of its kind to receive authorization,” from the FDA. And that it is now showing up in hospitals. In June, just after Clairity Breast was cleared by the FDA, the Breast Cancer Research Foundation – which funded some of the research into the technology – said the tech was “shaping the future of proactive, personalized breast cancer care.”
Government data indicates an estimated 316,950 new breast cancer cases will be diagnosed by the end of 2025 and that 42,170 deaths will be attributed to the disease this year. For those newly diagnosed, the five-year survival rate is estimated at 91.7%.
Mammograms are “the best breast cancer screening tests we have at this time,” per the American Cancer Society. However, these screenings have limitations and risks such as exposure to radiation.
Clairity Breast uses mammograms to create a risk score for the probability that a person will develop cancer within the next five years. This is different from other methods used to determine risk, which often factor in family history, genetic risks and lifestyle. Instead, the AI is trained on hundreds of thousands of mammograms to find patterns that would suggest someone is likely to develop cancer, Clairity founder Dr. Connie Lehman told NBC’s Savannah Sellers.
“Recent estimates suggest that the majority of breast cancers are not due to family history or genetic risk factors,” TODAY noted. A 2022 study in the Journal of the National Cancer Institute found that predictions from the Clairity model were often more accurate than traditional risk assessment tools.
AI has shown diagnostic potential in other research as well. In April of 2023, Audacy reported on “a study about Sybil, an artificial intelligence tool developed to detect for cancer on low-dose chest computed tomography scans,” that was being used to assess lung cancer risks. Later that year, Audacy reported on research that indicated AI detected cancer at a higher rate on breast cancer screenings compared to standard human-led readings.
Going forward, TODAY said Clairity “can be an important tool in identifying those with a higher risk for breast cancer.” However, it noted that this is also not a perfect form of screening.
“It doesn’t catch everybody who will get cancer in the next five years,” said Dr. Laurie Margolies, vice chair of breast imaging for the Mount Sinai Health Service, as cited by TODAY. “So we have to be careful that people don’t over-rely on it.”
Still, she said it is a great tool when used appropriately. Lehman explained that people with an average Clairity score are recommended to receive regular screenings, meaning mammograms every one to two years. Those with a higher risk score could receive further screenings such as MRIs, contrast-enhanced mammograms or ultrasounds, she said.
With recent polling showing that Americans have concerns about increasing healthcare costs, coverage of this screening is also a factor. TODAY said that Clairity is working to get the testing covered by insurance.
“For now, Lehman said, ‘We really believe that this test for women absolutely can be offered for less than $200,’” per TODAY’s report. She noted that the cost would be in addition to the cost for a mammogram. Mammograms are often covered if they are part of routine screening.