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

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 infections. 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 use 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 guaranteed 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 analysed.’

“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.

About Novosanis: Novosanis is an innovative developer and producer of medical devices adding value to the accuracy of diagnostics tests, vaccination based actions and the overall patient’s comfort.                                                                                                                                                                                                                           We are a medical device company active in the field of infectious diseases and oncology in the areas of prevention, detection and treatment. Novosanis prospers in user-friendly and smart medical devices meeting all regulatory and quality requirements, solutions that can improve the accuracy of the diagnostic test while making the handling easier, more consistent and more comfortable for the person. Currently we have two device platforms in portfolio:

- VAX-ID™, suited for accurate intradermal injections

- Colli-Pee™, suited for standardized collection of first void urine. Colli-Pee™ is in commercial stage and is CE marked.

For more information, please visit: www.novosanis.com or contact welcome [at] novosanis.com

For more information on Colli-Pee™, please visit: http://www.novosanis.com/devices/colli-pee

About GeneFirst Ltd: Based in Abingdon, England, GeneFirst Ltd is a molecular diagnostics company working predominantly in the fields of infectious disease, cancer diagnostics and personalized medicine. GeneFirst offers robust easy-to-use, sensitive, and affordable molecular diagnostics technologies and products to researchers, clinicians and drug companies to enable accurate diagnosis and the delivery of safe and effective medicines. Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis. For more information, visit www.genefirst.com or contact info [at] genefirst.com

References:                                                                                                                                                                                                                                             1. Fu, G. et al. Multiplex detection and SNP genotyping in aa single fluorescence channel. PLOS One 2012; Vol. 7, e30340.

2. Bhatia, R. et al., Performance evaluation of Papilloplex HV HPV Kit – A novel multiplexing assay for genotyping all 14 HR HPV types in a single closed tube Real-Time PCR reaction. Poster presented at the International Conference on HPV 2016, Chicago.

3. Vorsters, A. et al., Compatibility of GeneFirst Papilloplex HR HPV genotyping kit for testing first void urine specimens. Poster presented at EUROGIN 2016, Salzburg, Austria.

4. Accuracy of urinary human papillomavirus testing for presence of cervical HPV: systematic review and meta-analysis http://www.bmj.com/content/349/bmj.g5264