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New Assay for Neisseria gonorrhoeae (GC) Testing Incorporates Real-Time PCR Technology

-- BD MAX™ GC rt PCR Assay Receives CE Mark

BALTIMORE, April 9, 2014 /PRNewswire/ -- BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today the CE mark and launch of the BD MAX™ GC rt PCR assay in Europe. The BD MAX GC rt PCR assay is an in vitro diagnostic test intended for testing Neisseria gonorrhoeae (GC) positive results from the BD ProbeTec™ GC Qx Amplified DNA Assay performed on the BD Viper™ System with XTR™ Technology. The assay may be used for detection of GC DNA in residual male or female urine specimens, or residual endocervical, vaginal or male urethral swab specimens that have tested positive for GC using the BD ProbeTec GC Qx Amplified DNA Assay.

"This new assay marks another pivotal step toward increasing diagnostic accuracy and fulfilling our efforts to prevent the spread of infectious disease," said Alberto Mas, President, BD Diagnostics – Diagnostic Systems. "This new assay is a great addition to our existing solutions and provides an important tool to laboratorians and clinicians to improve the management of sexually transmitted infections."

Neisseria gonorrhoeae is one of the most prevalent sexually transmitted bacterial infections. Worldwide, more than 106 million cases are estimated to occur annually.[i] In Europe, following chlamydial infections, gonorrhoeae is the second most common sexually transmitted infection. In 2011, 39,179 gonorrhoeae cases were reported from the majority of EU Member States and the rate was estimated to be 12.6 per 100,000 populations.[ii] Men were reported to be infected three times more often than women, with an overall rate for men of 21.2 per 100,000 and 7.6 per 100,000 in women. Forty-two percent of cases were among young adults. Despite the increase of reported numbers, the incidence in several countries is underestimated because of suboptimal diagnostics, case reporting and surveillance.

Compared to culture, nucleic acid amplification test (NAAT) assays are more sensitive, allowing testing of a wide range of specimen types and can support extended transportation and storage conditions.[iii] NAATs have exhibited high sensitivity in both symptomatic and asymptomatic patient populations and equivalent sensitivity demonstrated between male urine and urethral swab specimens, and between clinician-obtained and patient-collected vaginal swabs.[iii] The BD MAX GC rt PCR assay is designed for use with specimens that have tested positive for GC on the BD Viper System. Automated DNA extraction, amplification and detection maximize laboratory efficiency and quality of results. High specificity helps to improve the positive predictive value in low prevalence populations as well as meeting regional guidelines.

About BD
BD is a leading medical technology company that partners with customers and stakeholders to address many of the world's most pressing and evolving health needs. Our innovative solutions are focused on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, supporting the management of diabetes and advancing cellular research. We are nearly 30,000 associates in 50 countries who strive to fulfill our purpose of "Helping all people live healthy lives" by advancing the quality, accessibility, safety and affordability of healthcare around the world. For more information, please visit www.bd.com.

[i] http://apps.who.int/iris/bitstream/10665/85376/1/9789241505895_eng.pdf
[ii] European Centre for Disease Prevention and Control. Sexually transmitted infections in Europe 2011. Stockholm: ECDC; 2013.
[iii] IUSTI / WHO. (2012). 2012 European Guideline on the Diagnosis and Treatment of Gonorrhoeae in Adults.

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