Hologic Inc.’s three-dimensional mammogram device is safe and improves breast-cancer detection when used in combination with conventional mammography, a U.S. panel said.
The machine is effective enough at finding tumors to justify the additional radiation exposure, outside advisers to the Food and Drug Administration said in a 12-0 vote today in Gaithersburg, Maryland. One panel member abstained from voting. While the FDA usually follows its panels’ recommendations, it isn’t required to do so.
The device, Selenia Dimensions 3D, is designed to find soft-tissue tumors that overlapping tissue can mask in two-dimensional images, the Bedford, Massachusetts-based company told the FDA in documents released Sept. 22. The product, already sold in Europe, Asia, South America and Australia, is intended for use with two-dimensional screening that detects calcium deposits, which can be malignant. Selenia was approved by the FDA in 2008 as a two-dimensional device and can be upgraded for both types of mammography if the agency clears the 3D technology.
“This, that I’ve seen today, is probably the tool that I’ve been looking for for the last 37 years,” panelist Leonard Glassman, a radiologist in Washington who has done breast imaging since 1973, said before the vote. “It will allow me to get rid of the overlap, to see around corners, to see behind things.”
FDA clearance of Selenia 3D may boost Hologic’s sales by at least $80 million in 2012, Joshua Jennings, an analyst at Jefferies & Co. in New York, said Sept. 22 in a telephone interview. More than 600 research universities in the U.S. would be the earliest potential buyers, he said. The company had revenue of $1.64 billion in the fiscal year ended Sept. 26, 2009.
Hologic rose 40 cents, or 2.5 percent, to $16.66 at 4 p.m. New York time in Nasdaq Stock Market composite trading. The company has gained 15 percent this year.
Panelists weren’t asked to vote on whether the device should be approved.
The company’s 3D screening, known as tomosynthesis, may render conventional mammography obsolete in three to five years, Chief Executive Officer Robert Cascella said Sept. 14 at a health-care conference in New York.
Health-care providers who already use Selenia as a two-dimensional device can have it upgraded for 3D imaging if the FDA clears the technology.
While Hologic’s 3D screening uses more radiation than a traditional digital mammogram, it’s unlikely to create safety risks for women who have the procedure only once a year, said Ira Loss, an analyst at Washington Analysis.
“The bigger issue is whether hospitals will buy it,” Loss, who has followed the agency for more than three decades, said Sept. 21 in a telephone interview. “There’s a lot of concern about reimbursement. It may be difficult to sell into this particular market.”