FDA ‘approvable letter’ sets stage for launchHologic is running the last lap of a marathon effort to bring its Lorad full-field digital mammography system to market. The company has received an approvable letter from
FDA ‘approvable letter’ sets stage for launch
Hologic is running the last lap of a marathon effort to bring its Lorad full-field digital mammography system to market. The company has received an approvable letter from the FDA based on the premarket approval (PMA) application it filed in May. The PMA was backed by three years of clinical data.
Final marketing clearance for the digital mammography system is subject to labeling discussions, an agreement on criteria for use of the product, and successful completion of a good manufacturing practices audit by FDA investigators of Hologic’s manufacturing facility in Bedford, MA. That audit is scheduled for late November, according to Jack Cumming, president and CEO of Hologic. Cumming is optimistic about the eventual outcome but said it would be premature to predict a timeline for final approval.
“We expect it shortly, based on the FDA’s review of other systems by GE and Fischer,” he said. “We expect it to happen for us in a similar time frame.”
Hologic obtained the system from Trex Medical, which it acquired in 2000. Trex originally tried to gain approval of the system but ran aground in the process two years ago. Problems stemming from the unsuccessful attempt contributed to Trex’s downturn and the subsequent purchase of its assets by Hologic.
“It’s a different environment now,” Cumming said. “During the early stages of digital mammography, the pathway was 510(k). That changed when the FDA determined that was not the road it wanted companies to travel. Trex had made a huge investment in the 510(k) approach, and migrating from that to PMA was obviously difficult.”
Soon after the acquisition of Trex, Hologic representatives met with the FDA to determine the swiftest and most accurate course to set toward approval, Cumming said.
“We were able to utilize some of the work done by Trex, and it was good work,” he said. “We supplemented that with additional research the FDA wanted to see completed. By following its instructions, we were able to put together a filing that met the FDA’s requirements. The FDA played a key role in guiding us toward what was necessary.”
The approvable letter and the follow-on process, while encouraging, put Hologic in a regulatory straightjacket. While the company is allowed to publicize the fact that an approvable letter has been received, it is barred from distributing repeat press releases promoting that fact or using the approvable letter as a marketing tool with customers, Cumming said. Hologic cannot market the product until final approval is given.
Because of Hologic’s desire to adhere strictly to the FDA’s rules concerning PMAs, Cumming refused to disclose sales predictions for the new system. He also declined to provide a ballpark figure for the new system’s sale price. There were other reasons for caution on Cumming’s part.
“We’re not going to put out any numbers on what we expect in sales,” he said. “It feeds the competition, and it isn’t knowledge that we’ve yet given to our shareholders. We don’t share that knowledge independently unless we share it with everybody. But I can say that we expect to achieve significant success in the sale of digital mammography systems.”
Cumming attributes that expectation to the base of customers cultivated by Lorad during its 14 years in business. The company has more than 3000 M-IV film-based mammography units installed. The new digital mammography system offers a clear upgrade path with no adjustment in technologist training or site redesign required, he said.
The digital system uses charge-coupled device technology. Once approved, it will give Hologic a foot in the door of the mammography market, an opening it plans to expand upon with a second-generation system. This next-generation device is based on proprietary amorphous selenium DirectRay technology, which is now in advanced stages of development.
“Our story goes beyond the approvable letter for our CCD technology,” he said. “Certainly, we will be talking at RSNA about the migration to selenium technology. Other companies are also doing this, and we believe that’s a validation of selenium as the means for producing and developing (sensor) plates with higher operating characteristics than are available today. We’ll have a lot to talk about.”