The plant inspection must have gone well, because the Food & Drug Administration approved Hologic Corp.’s (NSDQ:HOLX) one-of-a-kind 3d breast imaging platform, the Selenia, for performing mammograms.
Late last year, the federal watchdog agency told the Bedford, Mass.-based women’s health firm that only an inspection of its manufacturing facilities separated the company from a long-awaited approval of the system. It incorporates 3-D imaging with 2-D imaging for breast exams to give radiologists a clearer image with more data. The device’s tomosynthesis technology produces 3-D images by digitally combining multiple X-rays, alleviating the issues associated with distortion by tissue shadowing or density, according to the company.
"Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches," Center for Devices & Radiological Health chief Dr. Jeffrey Shuren said in prepared remarks.
In September, the system won unanimous favorable votes from the the agency’s Radiological Devices Panel on effectiveness and safety and that the benefits of the system’s technology outweigh its risks. Hologic has been waiting for approval of its the system since it submitted a pre-market approval application in 2008. The Selenia won European certification in June.
The first Selenia systems sold for tomosynthesis are likely to hit the U.S. before insurers decide how to reimburse for its use, but the platform can be used just for 2-D while Hologic waits for the final reimbursement call on 3-D screening.
The approval comes just in time for Hologic, which saw first-quarter profits plunge 58 percent. The company reported net income of $10.9 million, or 4 cents per diluted share, on sales of $432.6 million during the three months ended Dec. 25, 2010. But with nearly 40 million mammograms performed each year, the market for the new device &m,dash; the first 3d mammography system cleared for the U.S. market — Hologic stands to make some hay while the sun shines. The National Cancer Institute estimates that nearly 200,000 women are diagnosed with breast cancer each year; one out of eight women are hit with a breast cancer diagnosis during their lifetime. When caught early, however, while it’s still localized in the breast, there’s a 98 percent survival rate. And 1 in 8 women will be diagnosed with breast cancer during their lifetime. There is a 98 percent survival rate when breast cancer is detected early and still localized to the breast.
Physicians polled for a pair of the studies the FDA used in making its decision reported a 7 percent improvement in their ability to distinguish between cancerous and non-cancerous cases as compared to viewing 2-D images alone, according to an agency press release. Although the system exposes patients to roughly double the radiation of standard 2D mammograms, the improved accuracy caused fewer women enrolled in the studies to be recalled for diagnostic workups, according the FDA. The agency estimated the increased cancer risk to be 1.5 percent "compared to the natural cancer incidence, and less than 1 percent compared to the risk from conventional 2-D mammography," according to the release, noting that "there is uncertainty for radiation risk estimates."
Docs looking to use the new platform must take a mandatory eight hours of training on the Selenia.