FDA Panel Rejects Breast Cancer Screening Device
“We have, at the maximum, 15 cancers and 5 assessments by T-Scan; this would establish a new low for the FDA in terms of level of evidence,” Dr. Berry said before the 10-0 vote.
Dr. Akin disagreed. He explained in an interview, “The T-Scan identifies 5% of the population that has a fivefold greater chance of breast cancer than the rest of the population. … Since mammogram screening starts at age 40 for the general population (solely based upon the age at which their risk exceeds 1 in 300–400), it makes sense to screen younger T-Scan-positive patients, whose risk is three times higher than [that of] a 40-year-old,” he said.
Other gynecologists also spoke in favor of approval in the public comments forum at the meeting. Dr. Steven Goldstein, professor of ob.gyn. at New York University, noted that whereas 12,000 women aged 30–39 are diagnosed with breast cancer each year, only 9,000 women total are diagnosed with cervical cancer annually. “For all the talk these days about HPV and vaccines, the cervical cancer success story is really the result of screening—the Pap smear.” Moreover, “Clinical use allows maturation and further refinement of virtually all medical technology, and I'm confident the same would be true of electrical impedance, if given the chance,” he added.
No panelists had concerns regarding the safety of the device. A previous version, the T-Scan 2000, was deemed safe and effective by the FDA in 1999 for clarification of equivocal mammographic findings.
Dr. Ron Ginor, the CEO of Mirabel, noted that an ongoing trial of a larger and more diverse population of women in the U.S. military is underway. “The bottom line is this: … We have to figure out how we're going to take the appropriate leap of faith or not take a leap of faith and remain with no technology,” Dr. Ginor said.
Dr. Akin echoed this sentiment. “Unfortunately, women aged 30–39 in the U.S. currently find their own breast cancers 71 percent of the time, frequently when the tumor is at an advanced stage and treatment is no longer going to prevent high morbidity or death.”
Dr. Berry, however, believes that even in 39-year-olds, breast cancer is too rare and the device's sensitivity too low to justify its approval. “Among 1,000 39-year-olds flagged by the T-Scan, 5 would have cancer,” he said in an interview. “About three times as many women (15) among the 19,000 that are not flagged would have undetected cancer. … We don't know that the 5 women identified as having cancers would actually benefit, but we know that 995 women without cancers will experience a variety of negative effects, from anxiety because of their positive test result to biopsies.
“There's a reason mammography is not recommended for women in their 30s: The disease is so rare that the negatives clearly outweigh the positives,” Dr. Berry said.
The FDA usually follows the recommendations of its advisory panels.
