BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced today at EUROGIN 2013 that the Company has achieved CE/IVD marking of its BD TotalysTM MultiProcessor, an automated instrument that integrates the pre-processing for the BD SurePath™ Liquid-based Pap Test with a molecular aliquot, maintaining sample integrity while improving efficiency in the lab. The Company also supported a symposium at the conference which highlighted the performance of the new BD OnclarityTM HPV Assay on the BD ViperTM LT System, which is pending EU certification.
“These new products are part of BD’s integrated Women's Health portfolio and support full sample chain of custody, high diagnostic accuracy and a clear patient management approach all important elements to improving patient care,” said Paul Holt, Global Market Segment Leader, Women’s Health & Cancer BD Diagnostics. “When laboratories and physicians partner with BD Diagnostics, they benefit from highly customized, leading-edge solutions for the rapidly changing landscape of cervical cancer screening.”
The BD Totalys MultiProcessor provides the ideal balance of automation and flexibility streamlining processes and removing inefficiencies. The highly automated sample preparation for cytology and molecular testing helps enhance lab productivity, while random sample loading reduces hands-on time. The system provides remote diagnostic and service capabilities to maintain optimal system uptime.
The BD Onclarity HPV Assay targets E6/E7 DNA oncogenes and is designed to provide physicians access to broader HPV genotype information to guide informed treatment decisions for their patients. The BD Onclarity HPV Assay reports results on six discrete HR HPV genotypes (16, 18, 45, 31, 51 and 52) with the remaining eight high-risk types reported in three small groups: (33, 58), (35, 39, 68) and (56, 59, 66). High-risk genotype and genotype group results are obtained from the same sample with no additional processing steps.
The BD Onclarity HPV Assay is designed for the BD Viper LT System, a bench-top instrument that automates sample setup, DNA extraction, RT PCR• amplification and detection with minimal lab technician intervention during processing. The BD Viper LT System’s integrated design and ease-of-use supports the adoption in both cytology and molecular laboratory environments.
The BD Onclarity HPV Assay is pending certification in the EU and is expected to launch in Europe and Asia in December 2013.The product is not currently for sale or distribution in the U.S.
Virtually all cases of cervical cancer are caused by specific types of human papillomavirus (HPV).1 Although there are more than 100 HPV genotypes, 14 high risk (HR) genotypes are considered to be cancer-causing.2 Many women with a positive HR HPV result will clear the infection on their own before it progresses towards cervical cancer.3
BD (bd.com) is a leading global medical technology company that develops, manufactures and sells medical devices, instrument systems and reagents. The Company is dedicated to improving people's health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery and production of new drugs and vaccines. BD's capabilities are instrumental in combating many of the world's most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs approximately 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public.
* Real-time polymerase chain reaction
1. Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, et al. 1999. The Journal of pathology 189:12-19
2. Munoz N, Bosch FX, de Sanjose S, Herrero R, Castellsague X, et al. 2003. The New England journal of medicine 348:518-27
3. Moscicki AB, Schiffman M, Burchell A, Albero G, Giuliano AR, et al. 2012. Vaccine 30 Suppl 5:F24-33