Hologic is now forecasting a late 2010 launch of its Selenia Dimensions tomosynthesis three-dimensional mammography system, after recent discussions with FDA led the firm to back out of a planned June advisory panel review.

During the firm's fiscal second-quarter earnings call May 4, Hologic execs said the company will reanalyze existing data supporting its PMA for a breast cancer screening indication and ask FDA to reschedule the panel in six to nine months.

This is the second delay for Selenia Dimensions, which had been expected to launch in the U.S. last year. FDA sent a letter to the firm requesting additional information in July 2008.

Explaining the decision to postpone the device's panel review, CEO Jack Cumming said, "We reached the point where we had to weigh the risks and rewards of going to panel."

"Because of a fundamental difference in thinking by the current review team regarding the previously agreed upon approach since our original meetings, we believe there is risk in the submission not receiving approval," the exec continued.

Since the PMA was originally filed, the firm has "learned a great deal about what will be necessary to enhance approval and clinical adoption of [tomosynthesis], and [we] believe the previous study design was not optimum in those areas," Cumming said.

Hologic presented data at the Radiological Society of North America conference last year showing Selenia Dimensions provided a lower recall rate and could detect cancers in dense breasts. The device also received a CE mark late last year and is already marketed in Europe (¹ Also see "RSNA 2008 Annual Meeting In Brief" - Medtech Insight, 8 December, 2008., p. 15).

Among alternative paths Hologic is considering for the U.S. marketing application are "using our current data, analyzed differently, and/or submitting additional technical data to support the total value of tomosynthesis," Cumming said.

Regardless of the path chosen for the initial PMA, the firm will pursue a "multi-faceted" plan for Dimensions that includes collecting new data for additional indications and to support reimbursement in the U.S., noted Hologic President Rob Cascella.

"The intent would be that [new data] would be a follow-up and a strengthening of our original claim, which was screening," Cascella said. "In addition to that, we're looking at a variety of other claims ... that might segment the female population or focus on areas beyond just screening and into diagnostics."

In addition to disagreements with FDA personnel and study design concerns, Hologic claims its decision to postpone the panel review stems in part from economic uncertainty. The firm points out that the current market environment is not an ideal one in which to launch a premium-priced technology. Manufacturers of large capital equipment have been particularly hard hit by the recession.

"We believe a more phased-in approach, relative to approved indications, will allow for a more practical initial adoption and lay the foundation for a broader future rollout," Cumming maintained.

While Hologic is touting the advantage of a "phased-in" approach and says the delay is not related to Dimensions' efficacy, Wall Street views it as a significant setback.

"We see the FDA questioning the magnitude of the benefit of tomosynthesis over FFDM [full field digital mammography]," Morgan Stanley analyst David Lewis says in a May 5 report.

Lewis estimates that if additional data is required for the Dimensions application, approval could be pushed back 12 to 15 months. Such a delay could help competitor GE Healthcare, which also has been developing a tomosynthesis system. Analysts have estimated GE is about 12 months behind Hologic.

Dimensions is seen as key to future growth at Hologic, which relies heavily on its breast health business. Lewis points out that the existing Selenia 2D system already dominates the full-field digital mammography market with a more than 50% share, giving it little room for further expansion in a challenging economic environment.

Second-Quarter Corporate Sales Down 7%

Hologic reported revenue for the fiscal second quarter (ended March 28) of $402 million, a decline of 7% from the same quarter a year ago. The decline was primarily due to a 19% plunge in breast health revenue, to $180.1 million, as hospitals pulled back on Selenia orders.

The drop in breast health sales was partially offset by an 8.5% increase in revenue from Hologic's diagnostics business - which includes the ThinPrep pap test - to $135 million.

The company is optimistic about the outlook for diagnostics after FDA approval of its two human papilloma virus tests in March - Cervista HPV HR and Cervista HPV 16/18 (² 'The Gray Sheet' March 16, 2009, In Brief).

Hologic gained the HPV technology through its $580 million acquisition of Third Wave in June 2008 (³ Also see "Adiana Permanent Birth Control Device Endorsed By FDA Panel In 10-3 Vote" - Medtech Insight, 17 December, 2007., p. 13).

The firm launched the HR (high-risk) test in April and will roll out 16/18 this month, Cumming said. While the products are not expected to substantially contribute to the top line this year, the firm believes they have "promising revenue potential" in FY '10.

Cervista will compete with Qiagen/Digene's Hybrid Capture 2 , previously the only FDA-approved test for HPV.

Hologic decided during the quarter to cut its losses with another Third Wave product, a hepatitis C molecular test, after FDA said it would require a PMA, rather than a 510(k). CFO Glenn Muir noted the firm will continue to sell the test internationally.

Meanwhile, Hologic's Gynecology Surgical revenue totaled $63.8 million, up 16%. The division is awaiting approval of the Adiana permanent birth control device this year. In March, FDA deemed the product "approvable," pending inspection of Hologic's Costa Rican manufacturing facility, Cumming said. The agency's Obstetrics and Gynecology Devices Panel voted to recommend approval of Adiana in 2007, contingent on a post-market study comparing the device to an alternative method of permanent birth control (⁴ Also see "Adiana Permanent Birth Control Device Endorsed By FDA Panel In 10-3 Vote" - Medtech Insight, 17 December, 2007., p. 3).

Looking ahead, Hologic narrowed its fiscal 2009 revenue forecast to $1.625 billion-$1.65 billion. In February, the firm had lowered its forecast 10% to $1.625 billion-$1.675 billion (⁵ Also see "Hologic Mammography Device Revenue Erodes In Recession" - Medtech Insight, 9 February, 2009., p. 14).

- Brooke McManus (b.mcmanus@elsevier.com)

Hologic Expects 2010 Launch Of Tomosynthesis System After FDA Panel Delay

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