Molecular IVD Assay Identifies Women at High Risk for Cervical Cancer

Global efforts to eliminate cervical cancer focus on expanding coverage of human papillomavirus (HPV) vaccination and improving cervical cancer screening. However, within (primary HPV) screening programs, it is not possible to clearly distinguish within the positively tested women, those who have persistent and progressing cervical disease and those, for whom the disease might be regressing. Now, a new molecular assay that has been demonstrated as a sensitive follow-up test to identify HPV positive women with progressing cervical disease in direct need for colposcopy or other follow-up procedures will help to identify women at high risk for cervical cancer.

Fujirebio Europe (Gent, Belgium) and Self-screen B.V. (Amsterdam, The Netherlands) have entered into a commercial collaboration around the distribution of the PreCursor-M+ methylation-specific molecular IVD assay from Self-screen B.V. The test is intended for the qualitative detection of elevated methylation levels of cervical cancer biomarkers and may be used as a triage follow-up test of HPV positive women and women with ASCUS/ LSIL cytology results. It complements Fujirebio's HPV-specific molecular test portfolio. The PreCursor-M+ test is validated for samples taken by physicians as well as for samples collected by women (self-sampling), which can largely optimize the testing process and increase the participation rates in screening programs and follow up.

“Fujirebio has a long legacy in HPV testing, and it was important for us to bring new and complementary testing solutions to our many customers,” said Christiaan De Wilde, CEO Fujirebio Europe “The methylation test from Self-screen, a well-respected pioneer in convenient and powerful HPV testing solutions, is a perfect example of quickly meeting customer demand with market-leading solutions and strategic partnerships.”

“We are very happy that Fujirebio partners with us to transition into still necessary effective innovations. Both our companies share a long history in HPV diagnostics, so this partnership strengthens our joint ambitions in this field,” added Michelle Meijer, Chief Commercial Officer at Self-screen B.V. “Our methylation test can improve triage with significantly less over-referrals to the gynecologist and unnecessary treatments, and is compatible with lab- and patient-friendly procedures such as self-sampling.”

Related Links:
Fujirebio Europe 
Self-screen B.V.