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BD Diagnostics Fiscal Q1 Revenues Rise 3 Percent

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Becton Dickinson said this week that revenues for its BD Diagnostics unit increased 3 percent year-over-year in the first quarter of fiscal year 2014, helping to drive an overall 6 percent spike in company revenues.

For the three months ended Dec. 31, 2013, BD Diagnostics — which includes the company's BD Max and Viper LT molecular diagnostics platforms and associated assays; and the Totalys MultiProcessor for automated sample prep for cytology and molecular cervical cancer testing — recorded revenues of $672 million compared to $652 million in the same quarter last year.

Within BD Diagnostics, pre-analytical systems improved nearly 4 percent to $347 million from $335 million in the year-ago period, while diagnostic systems inched up nearly 3 percent to $325 million from $317 million.

Meantime, BD Medical, the company's largest segment, saw revenues rise 8 percent to $1.06 billion from $983 million, while BD Biosciences, the company's smallest segment, climbed 5 percent to $279 million from $265 million.

A full recap of BD's financial results can be found here.

In a conference call held to discuss BD's fiscal Q1 earnings, CEO Vince Forlenza said that BD Diagnostics placed more than 40 BD Max instruments in the US and Europe in the quarter, bringing the total number of placements to more than 300.

The company recently received US Food and Drug Administration clearance for its Staph SR and MRSA XT assays for BD Max, and continues to focus on menu expansion with another four assays anticipated to be cleared in fiscal 2014, including an enteric bacteria assay.

In addition, "our BD Totalys front-end automation launched in Europe recently and our early customer feedback has been very positive," Forlenza said. "We anticipate the US rollout of this instrument in 2015."

The Totalys system was originally set to launch in the US in the company's fiscal fourth quarter of 2013, but was delayed due to regulatory hang-ups. It is designed to automate sample processing from the company's SurePath sample vials, and manage chain of custody across its suite of molecular and cytology systems, and is intended to complement the Viper LT and human papillomavirus genotyping assay.

Finally, Forlenza disclosed that BD recently garnered CE marking for its new Viper LT platform and Onclarity HPV assay, and commercially launched the platform in Europe. Viper LT will provide fully integrated automated molecular test capability running both PCR- and strand displacement amplification-based tests, including Onclarity and a combined chlamydia/gonorrhea test. "Our BD Onclarity HPV assay is the first DNA-based HPV assay that reports broad genotyping results for each patient with no additional processes," Forlenza noted.

"These products support our women's health and cancer business and are fully compatible with our SurePath liquid-based cytology cancer screening test," he added. "We are particularly excited about our ability to provide broader HPV genotyping results as we see more clinical evidence that specific genotypes indicate a higher risk of developing cervical disease."

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