About 14 states have a law that requires radiologists to notify women if they’re found to have dense breasts. Another 18 states have either introduced similar legislation or are reviewing it. The reason is because of the challenges that it can pose to an accurate diagnosis. Women with dense breasts face a higher risk for breast cancer and that’s complicated by the fact that these cancers are tougher to detect. The variety of follow-up diagnostic approaches is also driving up screening costs.
A recent study underscored this challenge. The study by actuarial firm Milliman, of 1 million commercially insured women aged 30 to 64, looked at claims data from 2009-2011 to evaluate the per-episode cost of breast cancer screening and follow-on tests, which can include biopsies, MRIs, and molecular breast imaging. It found that biopsies generated a higher than average rate of false positives. About 17 percent of women screened with a mammogram had follow-on testing, which accounted for 40 percent of the screening costs. A couple of medical device technology developments are designed to improve the screening process and reduce healthcare costs.
Gamma Medica, which sponsored the study, got FDA clearance in 2011 for its molecular imaging device.
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In an interview, Gamma Medica CEO Jim Calandra said its technology offers a more cost-effective alternative to MRIs and is more accurate than mammographies. “We’re finding good traction with comprehensive breast cancer centers.” He pointed out two factors that are benefiting the company. The breast cancer notification law is increasing awareness of the challenge of diagnosing women with dense breasts. The Affordable Care Act is increasing the pool of people covered by healthcare and access to breast cancer screening. Calandra said that is creating more pressure to develop standard guidance and protocols for how to deal with women with dense breasts.
Last year it raised $16 million in a Series A round to expand its imaging device and a companion biopsy module.
Another alternative that has generated interest is digital tomography, which are also referred to as 3D mammographies. The FDA cleared the first imaging devices in this field in 2011 and it’s been associated with higher rates of detection than mammographies. But some experts say they’re not convinced and want further proof of the technology’s effectiveness.
[Photo credit: Annie Cavanagh, Wellcome Images]
