Interview Fujirebio-Novosanis: INNO-LiPA HPV Genotyping & first-void urine (Colli-Pee®)

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We recently had the opportunity to interview Rebecca Millecamps, a Marketing Manager at Fujirebio, a global leader in the field of in vitro diagnostics (IVD).

In 2019, Novosanis and Fujirebio, signed a worldwide, non-exclusive agreement for the distribution of  Colli-Pee®, Novosanis’ urine collection device for use with Fujirebio’s INNO-LiPA HPV genotyping Extra II assay. This partnership enables detection and full genotyping of Human Papillomavirus (HPV) in first-void urine (first 20 mL of urine) collected with Colli-Pee®.

You can listen to the full interview through our podcast:

 

Here are some of the key highlights from our discussion:

Why is screening for HPV important?
HPV is the most common sexually transmitted infection (STI) and a major cause of cervical cancer in women. Cervical cancer can be prevented if detected early.
Most cases of cervical cancer occur in women who are not screened and treated on a regular basis (1). Making sure women are adequately screened and treated is critical to reduce deaths from cervical cancer (2).”

What are the challenges surrounding HPV screening?
While public screening programs have been implemented in several countries, participation remains low even after standard invitations and reminder calls. Current screening methods are primarily cytology-based (Pap test and HPV testing). There are several reasons for poor participation. “The invasive nature of cervical sampling is disliked by women. It is also perceived as time consuming…Or they feel discomfort or embarrassment with the pelvic examinations.”

How will urine testing impact HPV testing?
Finding non-invasive and easy self-collection sampling method can improve participation in cervical screening programs. Urine as a sample type to detect HPV DNA is promising (3).
“A urine sample can be collected without the need for a clinician and sent by regular mail to the lab for testing. Based on investigations and surveys, clearly a non-invasive sampling method is the most preferred sampling method by women.”

What is the benefit of performing HPV genotyping in urine samples?
Urine sampling can improve HPV screening but can also be used for post-vaccination monitoring and epidemiological programs (4,5).
“An easier way to collect samples will make the programs easier to organise, less-costly, more efficient.”

Can a randomly collected urine sample be used?
First-void urine contains higher concentrations of HPV DNA than subsequent fractions (6).
‘’This enables a more accurate detection of cervical HPV (6)’’.
Colli-Pee®, is a unique urine collection device that allows the capture of first-void urine in a volumetric and standardized way. It is convenient and very easy-to-use.

How do you see the future for urine testing for HPV compared to cervical sample?
Urine sampling could be game-changing in the way cervical cancer is diagnosed in the future.“There is strong belief that urine sampling could change the world of testing, not only for HPV but also for other oncology markers. But there are still some challenges to overcome. There is still a need for education and awareness programs to make patients and clinicians more familiar with HPV testing in urine. Studies are continuously ongoing to generate more data and to create more awareness of the value of urine sampling for biomarker testing.”

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References:

1. Bray F. et al. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018; 68: 394-424

2. Marc Brisson et al.  Impact of HPV vaccination and cervical cancer screening on cervical cancer elimination: a comparative modelling analysis in 78 low-income and lower-middle-income countries.  The Lancet. Vol395, Issue 10224, P575-590, Feb 2020.

3. Ducancelle A, Reiser J, Pivert A, Le Guillou-Guillemette H, Le Duc-Banaszuk AS, Lunel-Fabiani F. Home-based urinary HPV DNA testing in women who do not attend cervical cancer screening clinics. J Infect. 2015 Sep;71(3):377-84. doi: 10.1016/j.jinf.2015.05.001. Epub 2015 May 9. PubMed PMID: 25964233.

4. Franceschi S, Clifford GM, Baussano I. Options for design of real-world impact studies of single-dose vaccine schedules. Vaccine. 2018 Aug 6;36(32 Pt A):4816-4822. doi: 10.1016/j.vaccine.2018.02.002. Epub 2018 Mar 21. PubMed PMID: 29571973; PubMed Central PMCID: PMC6066174.

5. Burroni et al. 2014. HPV prevalence in paired urine and cervical samples in woman invited for cervical cancer screening.  E. J Med Vir 87:508-515

6. Pattyn J, Van Keer S, Biesmans S, Ieven M, Vanderborght C, Beyers K, Vankerckhoven V, Bruyndonckx R, Van Damme P, Vorsters A. Human papillomavirus detection in urine: Effect of a first-void urine collection device and timing of collection. J Virol Methods. 2019 Feb;264:23-30. doi: 10.1016/j.jviromet.2018.11.008. Epub 2018 Nov 16. PubMed PMID: 30452931.

Read more and find latest research about HPV and urine sampling in our recent posters and white papers: