This story has been updated from a previous version to include information about BD's ongoing assay-development partnership with Diagenode.
Becton Dickinson's Diagnostics business remains on track to launch a Clostridium difficile assay in the US by the end of this calendar year, its third test for hospital-acquired infections to run on its fully automated BD MAX benchtop molecular testing platform, company executives said recently.
In addition, BD Diagnostics plans to launch a Trichomonas assay for its higher throughput Viper testing system in Europe by the end of the current quarter and in the US mid-2013; and plans to introduce a new benchtop version of Viper, called Viper LT, with accompanying tests for chlamydia, gonorrhea, and human papillomavirus genotyping throughout its fiscal year 2013 in both Europe and the US.
Concurrently, the company will introduce early next year a front-end automated sample processing system to complement its planned menu of assays for Viper LT as it looks to keep pace with competitors such as Hologic/Gen-Probe and Roche in molecular testing for women's health.
Executives from BD Diagnostics discussed these and other aspects of the company's molecular diagnostics strategy in a conference call last week recapping BD's financial results for the third quarter of its fiscal year.
For the quarter ended June 30, BD Diagnostics' revenues increased 4.7 percent, driven by its Preanalytical Systems division, David Elkins, BD's executive vice president and CFO, said during the call. For the first nine months of FY 2012, BD Diagnostics revenues grew 4.3 percent, Elkins said.
In the US, BD Diagnostics' revenues increased 0.8 percent in Q3, again driven by "solid sales" in the Preanalytical Systems division, Elkins said. However, the Diagnostics Systems unit declined about 0.5 percent, "partially due to a tough environment in our microbiology business and softness in our GeneOhm [hospital-acquired infection] platform," Elkins said.
Elkins also noted, however, that the BD MAX — which the company is positioning as its primary HAI testing platform — had its test for methicillin-resistant Staphylococcus aureus approved by the US Food and Drug Administration in early July, and that the company "expects our sales trajectory to improve as we continue to build out the platform on this menu."
The MRSA test is the second BD MAX assay to receive FDA approval and launch in the US this year. In March, the FDA cleared the BD Max Group B Streptococcus Assay for detecting GBS DNA in Lim broth cultures (PCR Insider, 3/29/2012).
The BD MAX — which began life as the HandyLab Jaguar system before BD acquired HandyLab in 2009 — is a six-color, fully automated, benchtop system that performs cell lysis, nucleic acid extraction, and PCR set-up, amplification, and detection; and is designed to accommodate a broad range of molecular tests — including in vitro diagnostic assays and laboratory-developed tests — as well as user-defined protocols and life science research applications.
The company is developing its own assays for the platform but has been partnering with multiple other firms and laboratories to build out the system's test menu.
BD also sells two real-time PCR-based GeneOhm assay kits: One for detecting the C. difficile toxin B gene from patient samples; and one for identifying both MRSA and S. aureus from positive BD BACTEC blood culture. Those assays, however, appear to be on their way to becoming an afterthought as BD Diagnostics rolls out BD MAX and its HAI test menu.
GeneOhm assay sales declined 0.9 percent in Q3, driven by "continued MRSA competitiveness and pricing pressure," Tom Polen, president of BD Diagnostics, said during the conference call. "We are continuing to see strong double-digit growth [for C. diff] but off of a smaller base than MRSA for now."
With the FDA approval of the BD MAX MRSA assay, which represents "the first large assay we have in MAX in our major markets," the company is now "focused on driving new MAX placements to accelerate our growth in that HAI space," Polen said. "We expect that's going to take a few quarters … to see that ramp. But we're getting very, very positive customer feedback as we're launching that at this time."
Polen reiterated that the company has "an aggressive menu" planned for BD MAX, with more than 15 assays in the pipeline, the next of which will be C. diff, "and we are on track to submit that to the FDA later this quarter," he said. "We have finished the clinical trial and are preparing the submission now, and that will go in later this quarter."
Polen noted that the company is also pleased with the progress of its partner assays, which include tests for respiratory, enteric, and central nervous system diseases being developed with Diagenode (PCR Insider, 5/12/2011); a test for Aspergillus fungal infections with Lab21 (PCR Insider, 8/4/2011); a menu of tests for infectious agents in immunocompromised patients with Italy's Biodiversity (PCR Insider, 8/18/2011); and pharmaceutical QC assays with Lonza (PCR Insider, 10/28/2010).
Polen said that BD expects the first of these partner assays — though he didn't specify which one — to launch in the EU before the end of this calendar year.
Moving to the Benchtop
While BD is positioning the BD Max to compete primarily in the molecular HAI and other infectious disease testing markets, it is pursuing a different strategy to tackle the STD testing market, and women's health in particular, by further expanding the test menu for its high-volume Viper system and by introducing a medium-throughput benchtop version of Viper.
BD received FDA clearance in 2006 for Viper, a fully automated high-volume laboratory testing system that features industrial robotics. The platform was originally approved to automate the company's amplification-based ProbeTec ET System assays for detecting Chlamydia trachomatis and Neisseria gonorrhoeae.
In 2009 the FDA cleared the BD ProbeTec CT and NG "Qx" Amplified DNA assays, which use the company's XTR strand displacement amplification technology, to run on the Viper system; and in 2011 the agency cleared similar BD assays to detect and differentiate herpes simplex virus types I and II on Viper.
Last week, BD President and CEO Vince Forlenza said during the conference call that in the fourth quarter of BD's 2012 fiscal year, which will end Sept. 30, the company plans to launch a Trichomonas assay on the Viper platform in the EU. The company will follow that with a Trichomonas assay launch in the US "in the back half of fiscal year 2013," Forlenza said.
Meantime, the company plans to launch a benchtop version of Viper, called Viper LT, along with a CG/NT assay in FY 2013 globally, followed by the launch of a Viper LT HPV genotyping assay outside the US, Forlenza said.
Polen explained that although BD has "a very solid platform" with the high-volume Viper testing system, the next-generation Viper LT will address different market segments – those being targeted by molecular diagnostic competitors such as Hologic's newly acquired Gen-Probe unit.
Polen noted that Viper LT would have "similar volume throughput" to the Gen-Probe Panther system, "but will be an actual benchtop" machine. "And then we'll have [strand displacement amplification] and PCR on it … and … our first PCR assay based on that platform will be the HPV genotyping assay, which we [will launch] about this time, slightly earlier, next year ex-US, and then we'll be announcing the US launch afterwards."
Along with the launch of the Viper LT, BD will introduce a front-end automation system for women's health under the brand name Totalys in the beginning of FY 2013 in the EU and later in the year in the US, Forlenza said, noting that the launch of this product line has been delayed by a quarter.
The Totalys automation system, Forlenza noted, "will automate sample processing from our SurePath sample vials and manage chain of custody across our suite of molecular and cytology systems. This will complement our upcoming launch of the Viper LT and our fully automated HPV genotyping assay."
This combined sample processing/molecular testing offering again follows a similar tack to Hologic. In response to an analyst's question about the potential increased competitive pressure from a combined Hologic/Gen-Probe entity, Polen responded that "Gen-Probe has been very publicly in play over the last year, and so the acquisition didn't come as a surprise. We've made our integrated molecular cytology strategy in women's health very clear for some time now, through Totalys and the Viper LT platforms. … Hologic makes it clear they see value in a similar approach."