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BD Execs Provide Update on MDx Pipeline, NGS Sample Prep Initiative

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NEW YORK (GenomeWeb) — Becton Dickinson executives this week updated investors on its molecular diagnostics sales and development pipeline, and provided a window into the company's plans for GenCell, the next-generation sequencing sample prep firm it acquired last month.

Company officials discussed these items and more during a conference call recapping BD's fiscal fourth quarter and full-year 2014 financial results. For the three months ended Sept. 30, BD reported revenues of $2.2 billion, a 5 percent uptick from the same quarter last year that was driven primarily by the company's Medical and Diagnostics segments.

The company also noted during its earnings call that as of October it is reorganizing into a two-segment structure consisting of BD Medical, which will contain medical/surgical systems, pharmaceutical systems, and diabetes care units; and BD Life Sciences, which comprises the pre-analytical systems, diagnostic systems, and biosciences business units.

A full recap of the company's fiscal Q4 and full-year earnings can be found here.

During the call, BD CFO Christopher Reidy noted that 4 percent Q4 growth in the BD Diagnostics segment was driven by "solid sales" of pre-analytical systems, safety engineered products, and diagnostic systems, the latter of which benefitted from strong sales in microbiology and its Kiestra clinical microbiology lab automation product. For fiscal year 2014, the Diagnostics segment grew 3 percent.

In the US, Q4 Diagnostics sales were flat year over year. This reflected solid growth in preanalytical systems and strong growth in microbiology, Reidy said, but was offset by softness in women's health and cancer due to extended cervical cancer screening intervals.

"We also continued to experience US share losses in our ProbeTec business, which is consistent with what we've communicated the past two quarters," Reidy said.

ProbeTec is the brand name for BD's molecular assays based on strand-displacement amplification. The company's primary ProbeTec assays, for chlamydia and gonorrhea, for several years ran on the company's higher-throughput Viper XTR testing platform, but were cleared by the US Food and Drug Administration in late July for use on the Viper LT system, which is designed for medium-sized laboratories. The company had previously stated that the availability of the ProbeTec CT/GC on the Viper LT would help staunch sales erosion.

Alberto Mas, president of diagnostic systems at BD, confirmed during the call that share loss in the ProbeTec business has been on the CT/GC side, and "is mostly behind us."

The company may be further aided in its efforts to pump up sales of CT/GC testing when the assay launches on the BD Max, the company's sample-to-answer platform designed to accommodate both commercial and laboratory-developed assays.

Mas noted that the company has filed for the CE mark for the test and expects a fiscal Q3 launch, which would be in the second quarter of the 2015 calendar year. "For the US, we're working on a next-generation assay that will be more into [2016], and we'll update when we have a little bit more visibility on the date," Mas said.

Linda Tharby, the new president of BD's Life Science segment, also noted that the company was "doing very well with our core micro[biology] business, with our flu business, and also increased placements on our Max systems," although the company did not disclose sales figures for the platform.

In fiscal 2014, BD launched its Staph SR and MRSA XT assays, as well as an enteric bacteria panel, worldwide on the BD Max system. The company also launched an enteric parasite panel for BD Max in the EU.

The company also launched the aforementioned ProbeTec GC/CT assay, as well as the BD Onclarity HPV-GT assay, on the Viper LT.

During this week's call, the company also updated its timeline on various other assays for the BD Max. An enteric parasite panel is set to launch in Q3 of fiscal 2015, a one-quarter delay. Meantime, and extended enteric bacterial panel and separate enteric viral panel are both set to launch in late FY 2015 or early FY 2016 in the EU; while a BD Max vaginitis/vaginosis assay is set to hit the market in FY 2016.

Like many molecular diagnostics developers, BD is also eyeballing rapid Ebola testing. During the call, CEO Vince Forlenza said that with the company's recent launch of the Total Nucleic Acid kits on the BD Max, "the diagnostics team has been working closely with multiple organizations to develop fully automated diagnostic tests for Ebola detection. Our molecular scientists and global partners are actively pursuing a fast, accurate, and fully automated molecular detection solution that would fit in with the needs of the developing world, which is most impacted by the disease."

'Targeted' NGS

Last month, BD made its first foray into the next-generation sequencing market when it acquired Irish sample prep automation firm GenCell for an undisclosed amount.

GenCell has developed a proprietary microdroplet reaction technology called composite liquid cell (CLiC). One of its first applications is an automated library preparation platform for NGS called CLiC LP, which promises lower running costs than other methods. GenCell had been planning to start shipping the instrument this summer.

During this week's call, Forlenza noted that BD was underway with the integration of GenCell, and that the acquisition was a "very targeted play" and marked a "great opportunity" for the company.

"As the NGS market moves to the clinic, BD is well positioned with relevant experience in bringing products from research to clinical markets, pre-analytical sample collection, and sample preparation in diagnostic systems," Forlenza said. "BD will combine this experience with GenCell's proprietary technology to meet unmet needs with [an] upfront NGS workflow."

Further commenting on the acquisition, Tharby said that BD was motivated by the fact that upfront sample and library prep for NGS currently takes upwards of two days to perform, "which is just too long if we bring it to the clinic. GenCell really provided us the opportunity to get into that library prep phase and …consolidate the workflow, automation, [and] scalable throughput."

Tharby told analysts to consider the sample collection work that BD currently performs with Qiagen, presumably under the companies' joint PreAnalytiX venture, "and being able to expand upon that right through to the work we do in diagnostics. As this moves to infectious disease, we see a lot of opportunities to provide BD's skills combined with the technology of GenCell over the long term."

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