HPV is the most common sexually transmitted infection (1). While most infections are subclinical, two virus serotypes are known to be carcinogenic. The lack of symptoms and the discomfort associated with traditional screening methods, such as pap tests or swabs, lead to an ineffective disease prevention as 40% of women in the EU do not participate in local government lead screening programs. However, the University of Antwerp spin-off Novosanis has developed a non-invasive alternative that can overcome this barrier.
Their home self-sampling device, Colli-PeeTM, allows an easy collection of first-void urine of both men and women. Thanks to its innovative design, the disposable product collects the first 20 mL and lets the rest flow through freely. The collected fraction contains the highest concentration of DNA, RNA and protein for analysis. However, it is usually not collected properly in traditional urine samples as women find it difficult to aim and men to interrupt their stream.
The design and development of Colli-PeeTM was funded by the IWT and was awarded the 2015 IWT award for the project with the highest social relevance. Indeed, HPV diagnosis is important as the WHO has estimated there were 528.000 cases of cervical cancer in 2012 worldwide, resulting in 266.000 deaths (2). Furthermore, first-void urine can not only be used for the detection of HPV, but also for other STI’s such as chlamydia or gonnorhea, or even prostate cancer biomarkers.
In early 2015, the device obtained CE marking and was ready for large scale production. Novosanis acquired EU funding to validate the assays and support to perform a feasibility study. The suitability of HPV DNA detection in first-void urine might replace the current screening methods.
(1) Satterwhite CL, Torrone E, Meites E, Dunne EF, Mahajan R, Banez Ocefemia MC, et al. Sexually transmitted infections among US women and men: prevalence and incidence estimates, 2008. Sex Transm Dis. 2013;40(3):187–93.
(2) World Cancer Report 2014. World Health Organization. 2014. pp. Chapter 5.12. ISBN 9283204298.