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Hologic Officials Encouraged by HPV Test Adoption as Q2 Sales Inch Up


NEW YORK (GenomeWeb) — Hologic said this week that its molecular diagnostics sales declined 8 percent year over year in its fiscal second quarter, but increased 1 percent when adjusted for the divestiture last year of its Lifecodes transplant diagnostics segment.

Hologic's adjusted growth in molecular diagnostics, which includes the company's Panther testing system and associated Aptima assays, helped mitigate an overall 2 percent decline in revenues, or 4 percent on adjusted basis, in its Diagnostics segment. Overall, the firm's revenues were up 2 percent year over year.

A full recap of Hologic's fiscal Q2 earnings, including information about its recently completed strategic review, can be found here.

"Our molecular diagnostics business declined 8 percent, primarily as a result of our divestiture of Lifecodes," CFO Glenn Muir said in a conference call this week following the release of Hologic's earnings. "However, operationally, after adjusting for Lifecodes, molecular grew 1 percent." Muir noted that overall performance in molecular was was affected slightly by weakness in Hologic's flu business. "However, our core Aptima franchise experienced healthy growth in the low-double digits resulting primarily from strong uptake at Quest and broader adoption of Aptima HPV," he said.

Last June Hologic entered into a strategic alliance with Quest Diagnostics to more broadly offer testing based on the Aptima family of products, with a particular focus on human papillomavirus testing.

Hologic CEO Stephen MacMillan said during this week's call that during fiscal Q2 Hologic made "solid progress on executing on our opportunity to convert Quest testing volumes to our Aptima family of assays … and even aside from Quest, we are driving broader adoption of our Aptima HPV test, and are encouraged by our progress."

During the call, an analyst questioned MacMillan about the expected impact of the US Food and Drug Administration's recent approval of Roche's competing Cobas HPV assay for use as a first-line, primary screening test for cervical cancer in women 25 years and older.

The analyst posited that the approval could provide an opportunity for Hologic's molecular Aptima HPV assay, but it also could present a challenge to the company's ThinPrep cytology business, which has been underperforming in recent quarters as molecular methods become more commonplace.

"In the short-term, on ThinPrep, we frankly don't see much impact," MacMillan said. "When you think about how well-established the Pap test is, also in terms of co-testing and the guidelines and the conservative nature of the specialists involved here, we think this is going to take some significant time. Over years, will it start to have an impact? Yes. In the coming quarters, probably don't expect much."

However, MacMillan noted that Hologic is nevertheless taking a conservative tack with its revenue guidance. "We always plan to be conservative and hopefully be better off," he said. "Long-term, I think as we become a major player in the HPV space, it probably does create some opportunity for us as well and we like our growth there. But again, clearly Roche is going to be a tremendous competitor there. It has the leg up on this particular chapter."

In general, Hologic had "another strong quarter" of Panther placements, MacMillan said, noting that the company is "increasingly confident" in its goal of installing 1,000 total units by the end of fiscal 2015.

Helping Hologic attain that goal will be a contract recently signed between Hologic's blood screening partner Grifols and the Japanese Red Cross to screen the country's 5.3 million annual blood donations using Panther and relevant Aptima assays.

"This represents a huge win for Grifols and us, and is a strong validation of Hologic's Panther system and its capabilities," MacMillan said. "The JRC made its selection after rigorous scientific evaluation of our instrumentation and assays in comparison with the latest offerings from the incumbent vendor. The technological advantages of Panther and the benefits it delivers in terms of workflow, reliability, and ease of use are becoming more evident in ongoing competitive evaluations."

MacMillan said that this contract will begin toward the end of Hologic's fiscal 2014, and as such, the majority of the initial financial contribution will be realized in fiscal 2015. "This win is a great way to kick off our new relationship with Grifols, and we look forward to working closely with them to win additional business around the globe," MacMillan added.

Muir noted during the call that blood screening revenues were up nearly 6 percent year over year in fiscal Q2, with "strong international growth helping to offset the anticipated impact of lower domestic blood donations." He noted, however, that "the recent JRC win will build on our strength in international markets."