On October 11, 2022 Fujirebio Europe and Self-screen B.V. reported a commercial collaboration around the distribution of the PreCursor-M+ methylation-specific molecular IVD assay from Self-screen B.V (Press release, Fujirebio Diagnostics, OCT 11, 2022, View Source [SID1234621917]). 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.
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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 procedures2,3.
"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.