BD achieves CE-IVD mark on Onclarity HPV Assay


BD has revealed it has achieved the CE-IVD mark for the Onclarity HPV Assay on the new Viper LT System for the diagnosis of cervical cancer.

The investigation targets E6/E7 oncogenes in a patient's DNA and provides physicians with access to the broader High Risk HPV genotype information beyond types 16 and 18, in an effort to ensure informed treatment decisions can be made.

“BD has announced it has achieved the mark on the new BD Viper LT System“

Through this process, individual and grouped genotype results can be obtained from the same sample without the need for additional processing.

Paul Holt, BD's global business leader for women's health and cancer, said: "Cervical cancer continues to be a major health issue around the world and poses a significant threat to women's health. The launch of our new platform and assay offers physicians a more complete assessment of a patient's risk."

Almost all cases of cervical cancer are caused by specific types of human papillomavirus and although there are more than 100 genotypes of this manner, only 14 are currently considered to be cancer-causing. 

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