CE Mark awarded for Papilloplex HR-HPV diagnostic for cervical cancer.-Gene First Ltd

GeneFirst Ltd announced the release of Papilloplex HR-HPV to be marketed as a CE-IVD product under the European Directive on In Vitro Diagnostic Medical Devices.

There is a direct link between persistent HR-HPV infection and progression to cervical cancer and this has created a major diagnostic opportunities. Accurate molecular detection of HR-HPV genotype is of great use for cervical screening programmes, monitoring treatment and epidemiological studies. Popular genotyping methods uses either hybridization or multi-tube PCR. Papilloplex HR-HPV Genotyping Kit can detect and differentiate all 14 HR-HPV types together with a cellular control target in a single closed tube real-time PCR. The kit is suitable for use with not only cervical swabs (liquid-based cytology) but also on first-void urine samples. Urine samples are now gaining popularity for cervical screening programs due to their potential increased uptake rate. Papilloplex will be the first CE-marked kit for HR-HPV that includes first-void urine as a sample type.