First CE marked HPV test offering possibility to use first-void urine

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Wijnegem, Belgium, October 30th 2016: Novosanis, a medical device company based in Wijnegem Belgium, together with GeneFirst, a molecular diagnostic company based in Oxfordshire UK, announced CE Marking and launch of Papilloplex® HR HPV, a molecular diagnostic test for genotyping 14 High Risk cervical cancer-related Human Papillomaviruses.

Both companies today announced the launch of the CE-IVD marked Papilloplex® HR HPV, a molecular diagnostic test for High Risk (HR) cervical cancer-related human papillomaviruses (HPV)  enabling analysis of DNA from these HR HPV types on a standardized first-void urine sample using Novosanis’ patented medical device Colli-Pee™ next to analysis of cervical swab.

Human papillomavirus (HPV) is one of the most common sexually transmitted infection. Out of 100+ genotypes, only 14 high-risk (HR) HPV types cause cervical cancer. Accurate molecular detection of HR HPV genotype is of great use for cervical cancer screening, monitoring treatment and epidemiological studies. Currently available genotyping methods uses either hybridization or multi-tube PCR approach. The GeneFirst 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 reaction.

“HPV related cancers remain a major world-wide health problem. Obtaining CE Marking of Papilloplex HR HPV Genotyping Kit offers clinicians a simple, affordable and reliable test for HPV detection and genotyping,” commented Guoliang Fu, GeneFirst’s Chief Executive Officer. “Launching the first product based on our MPA technology is a significant milestone for GeneFirst, and aligns with the company’s strategic focus to drive forward new product development in the areas of oncology and infectious disease”.

"Papilloplex provides an important improvement over most existing restricted- or limited-genotyping commercial assays which do not detect all HR HPV types or, even worse, tests that fail to discriminate among HPV types,” commented Professor Clementina Cocuzza, of the Department of Medicine and Surgery, University of Milan-Bicocca, Italy.

The kit is suitable for use with not only just 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 increased uptake rate and ease of sample collection. Novosanis’ Colli-Pee™ is a patented and CE-marked sampling device suited for standardized and volumetric collection of 20ml first-void urine.

Alex Vorsters, PhD and senior project manager/researcher at the University of Antwerp commented: ‘We have already demonstrated that standardized first void urine collection is well accepted by women and is suitable for monitoring impact of preventive and therapeutic HPV vaccinations. The use of first void urine as sample type for cervical screening or follow-up of HPV treatment looks very encouraging and is being further analyzed.’

“It’s been a pleasure collaborating with GeneFirst on detection of HR HPV using the Papilloplex Genotyping kit with standardized first-void urine samples obtained with the Colli-Pee device. The kit will be the first CE-marked kit for HR HPV that includes first-void urine as a sample type. Colli-Pee’s ease of use fits perfect in the overall strategy of Papilloplex HR HPV. Looking forward to future collaborations.” says Vanessa Vankerckhoven, CEO Novosanis, Belgium.