CERVAG: how the vaginal microbiome affects HPV infection and cervical cancer

Cervical cancer (CC) is an important health problem that can be prevented by screening. The tests currently used for screening (HPV tests and PAP tests) are far from perfect because they lack specificity; Of the 10% HPV positive women, less than 0.5% is at risk, resulting in > 40% unnecessarily referrals for further examination, leading to worries for healthy women and associated pressure on the health system. In the CERVAG project, Radboudumc and Predica Diagnostics will develop the CERVAG test to identify those women who actually need to be referred for colposcopy. 

In the Netherlands in 2002 330,000 of 720,000 invited women responded to a screening invitation. Of the approximately 36,000 positive tests, only 3,000 needed treatment for a precancer, whereas thousands of healthy women were referred to gynecology clinics, undergoing unnecessary medical examination often with a biopsy. This low specificity comes at a cost of >21 million per year on unnecessary healthcare, and may even lead to a negative annotation to screening. A more reliable test may increase participation in population-based screening for CC, an important factor in eradicating CC. 

HrHPV infection is thus necessary but not sufficient for the development of CC. Specific bacterial gene products, found in bacterial vaginosis (BV) increase the incidence of HPV-induced cervical (pre)cancers. The CERVAG test includes bacterial gene expression with hrHPV-gene activity and hrHPV-induced human gene products to distinguish between non-dangerous HPV infections and dangerous HPV infections. Implementing CERVAG-test as a triage test into the national screening program could save the Dutch healthcare system over 20 million euros yearly. 

The CERVAG project will deliver a test that can as such be performed as a service for fee test from Predica Diagnostics. Customers are screening organizations/gynecologists/ general practitioners who wish to determine the need for treatment or determine the efficacy of treatment. 

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