Integrated Cervical Cancer Testing Provides Leading-Edge Solutions for New Screening Needs

An integrated set of assays and instruments used for cervical cancer testing enables laboratories and physicians to provide high diagnostic accuracy combined with screening efficiency for their patients.

Virtually all known cases of cervical cancer are caused by specific types of human papillomavirus (HPV), with 14 HPV genotypes being considered high-risk (HR) for causing cancer. BD Diagnostics, a segment of Becton, Dickinson and Company (BD; Franklin Lakes, NJ, USA), has announced at EUROGIN 2013 that BD has achieved CE/IVD marking of its “Totalys” MultiProcessor, an automated instrument that integrates the preprocessing for BD’s “SurePath” Liquid-based Pap Test with a molecular aliquot, maintaining sample integrity while improving laboratory efficiency. At the conference, BD also highlighted the performance of its new “Onclarity” HPV Assay on the BD “Viper” 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.

The Totalys MultiProcessor provides 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 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. The assay reports results on six discrete high-risk HPV genotypes (16, 18, 45, 31, 51, and 52) with the remaining eight HR genotypes reported in three small groups: (33, 58), (35, 39, 68) and (56, 59, 66). HR genotype and genotype group results are obtained from the same sample with no additional processing steps. The 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 Viper LT System’s integrated design and ease-of-use supports adoption in both cytology and molecular laboratory environments. The BD Onclarity HPV Assay is pending EU certification and is expected to be available December 2013 in Europe and Asia (not currently for sale or distribution in the USA).

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