Fujirebio Europe announced today that its genotyping assay for Human Papilloma Virus (HPV), INNO-LiPA HPV Genotyping Extra II received a CE Mark for use with self-collected first-void urine samples.
HPV is a sexually transmitted virus. A number of strains (genotypes) of this virus are known to cause cancers in both men and women, but most notably, HPV is the primary cause of cervical cancer in women (1,2,3). When HPV infection is diagnosed and genotyped effectively, the potential for this virus to cause cancer can be substantially reduced. (2,3)
Historically, testing for this virus has required the collection of tissue samples using cervical or other body-site swabs. The sampling process can be embarrassing and inconvenient, and statistics show that for a variety of cultural, religious, and lifestyle reasons, women are not undergoing cervical cancer screening as often as they should.(4,5) By making it possible to genotype HPV infections with a urine sample that is painlessly collected by the patient in privacy, it is hoped that HPV testing rates can be increased, vaccine efficacy studies simplified, and lives saved. (6,7,8)
In order to collect urine samples reliably, Fujirebio Europe distributes the CE marked Colli-Pee™ first-void urine collection device manufactured by Novosanis. This patented urine collection device simplifies and standardizes the private and painless collection and preservation of first-void urine samples from both men and women.
About INNO-LiPA HPV Genotyping Extra II
Over the years, INNO-LiPA HPV Genotyping Extra II has been widely demonstrated to generate sensitive and specific results for 32 genotypes of HPV using cervical swab samples (liquid-based cytology) (9) and paraffin-embedded tissue (FFPE) (10). The SPF10 PCR target used in the INNO-LiPA test can genotype infections with low viral load, “masked” HPV types, and mixed HPV infections. (9,10,11) The newly validated urine protocol makes it possible to achieve these results on UCM-preserved first void urine samples (see IFU).
Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.
Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.
Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.
Fujirebio is today a member of Miraca Group (Miraca Holdings Inc. listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.
1. Walboomers JM et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999;189:12–19
2. IARC Monogr Eval Carcinog Risks Hum 2012;100B:255–313
3. F. Xavier Bosch et al. Comprehensive Control of Human Papillomavirus Infections and Related Diseases. Vaccine. 2013 Nov 22; 31(0 8): I1–31
4. Verdoodt et al. 2015. Reaching women who no not participate in the regular cervical cancer screening programme by offering self-sampling kits: a systematic review and meta-analysis of randomized trials. Eur J Cancer. 51 (16):2375-85
5. Racey CS et al. Self-collected HPV Testing Improves Participation in Cervical Cancer Screening: A Systematic Review and Meta-analysis. Can J Public Health 2013;104(2):e159-e166
6. O'Leary MC et al. HPV type-specific prevalence using a urine assay in unvaccinated male and female 11- to 18-year olds in Scotland. Br J Cancer 2011. 104(7):1221-1226.
7. Ducancelle A. et al. Interest of human papillomavirus DNA quantification and genotyping in paired cervical and urine samples to detect cervical lesions. Arch Gynecol Obstet 2014; 290(2):299-308
8. Burroni E. et al. Human papillomavirus prevalence in paired urine and cervical samples in women invited for cervical cancer screening. J Med Virol. 2015; 87(3):508-15
9. Xu L. et al. Clinical Evaluation of INNO-LiPA HPV Genotyping EXTRA II Assay Using the VALGENT Framework. Int J Mol Sci. 2018; 19(9), 2704
10. Ahmadi S. et al. Human Papilloma Virus Genotype Distribution in Cervical lesions in Zanjan, Iran. Asian Pac J Cancer Prev. 2017; 18(12):3373-3377
11. Sohrabi et al. Is incidence of multiple HPV genotypes rising in genital infections? J Infect Public Health. 2017; 10(6):730-733