FUJIREBIO-EUROPE

Fujirebio Europe and Self-screen B.V. today announce 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 human papillomavirus (HPV) positive women and women with ASCUS/ LSIL cytology results. It complements Fujirebio's HPV-specific molecular test portfolio.

Every year, more than 340,000 women across the world die from cervical cancer¹, even though it is a preventable disease. Global efforts to eliminate cervical cancer focus on expanding coverage of 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. The PreCursor-M+ methylation-specific molecular assay 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^2,3.

“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,” says 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,” says 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.”

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. Please contact Fujirebio for further information about the local availability of the test.

About Self-screen B.V. 
Self-screen B.V., has a long history and track record in translational HPV related research, assay development and commercialization. Currently, the company’s main focus is on cervical (pre)cancer screening and prevention to support full molecular cervical screening and to assist the clinician in management of women with high-grade cervical intraepithelial neoplasia (CIN) with two clinically validated IVD assays, the HPV-Risk-Assay and the PreCursor-M+ test, for screening and triage respectively.

Self-screen’s R&D pipeline focuses on extension of its assays towards other sample types, such as self-collected cervical vaginal specimens or urine, on various platforms and for the detection of other cancer types.

About Fujirebio 
Fujirebio is a global leader in the field of high-quality IVD testing. The company has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.

Fujirebio has a long-lasting tradition for developing high-quality routine and truly novel biomarkers. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions covering a variety of disease states.

Global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.

References:

1. https://www.who.int/news-room/fact-sheets/detail/cervical-cancer
2. Kremer WW, Steenbergen RDM, Heideman DAM, Kenter GG, Meijer CJLM. The use of host cell DNA methylation analysis in the detection and management of women with advanced cervical intraepithelial neoplasia: a review. BJOG 2021;128:504-514
3. Bonde J. et al. Int. J. Cancer. 2021;148:396-405. Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study.

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