BD Diagnostics has achieved CE/IVD marking for the BD Onclarity HPV assay on the new BD Viper LT system.
The BD Onclarity HPV assay targets E6/E7 DNA oncogenes and has capabilities that will go beyond current HPV tests on the market that provide a pooled result and discrete genotyping information for Type 16 and 18 to guide informed treatment decisions for their patients.
The assay provides additional reporting of six discrete high risk human papillomavirus (HPV) genotypes (16, 18, 45, 31, 51 and 52) with the remaining eight high-risk types in three groups (33, 58), (56, 59, 66) and (35, 39 and 68). High-risk and genotype assay results are obtained from the same sample with no additional processing steps required.
BD Diagnostics – Diagnostic Systems Women’s Health and Cancer global business leader Paul Holt said: "The launch of our new platform and assay offers physicians a more complete assessment of a patient’s risk.
"It is now clear that high-risk HPV genotypes differ in their ability to persist and lead to cervical cancer."
Recently, the BD Onclarity HPV assay was clinically evaluated according to International Guidelines for clinical HPV assay performance and met all acceptance criteria.
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The clinical performance of the BD Onclarity HPV assay was evaluated at three HPV laboratories in London, Copenhagen and Edinburgh and found to be similar to the reference method.
According to the company, the independent study also demonstrated excellent inter and intra-laboratory assay reproducibility in the respective laboratories.
The BD Viper LT System, a bench-top molecular platform, automates sample processing, DNA extraction, Real-Time Polymerase Chain Reaction (RT-PCR) amplification and detection with minimal lab technician intervention during processing.
It is designed to manage sample tubes with cap piercing and ready to use reagents. The ‘load and go’ capability and ease of use design of the BD Viper LT system delivers true walk away potential that maximises laboratory productivity.
The dual combination provides an innovative solution that enhances clinical utility, increases flexibility and improves laboratory efficiency in the pathology and molecular laboratories.
According to GlobalData estimates, the European infectious immunology market was valued at $1.74bn in 2012 and is expected to grow at a CAGR of 3.8% to reach $2.25bn by 2019.