Gamidor Diagnostics receives distribution rights from Self-screen to market PreCursor-M family of methylation-specific molecular assays to identify high risk for HPV induced cancers.
Petach Tvika, Israel and Amsterdam, The Netherlands – November 4, 2024: Gamidor Diagnostics and Self-screen B.V. today announce a commercial collaboration around the distribution of the family of PreCursor-M methylation-specific molecular assays from Self-screen B.V.. Gamidor will offer the suite of three assays to the Israeli market. The PreCursor-M+ IVD assay 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. Furthermore, the PreCursor-M Gold and PreCursor-M AnoGYN RUO assays are the new generation assays with clinical use in urine sampling and anal cancer detection respectively. Self-screen methylation assays complement Gamidor’s Women’s Health and HPV-specific molecular test portfolio.
Every year 350,000 women across the world die from cervical cancer, 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 by HPV testing. In screening however an import point for women who have tested HPV positive is to identify only those with persistent and progressing cervical disease as they need treatment and at the same time prevent overtreatment and referral for those without this disease. 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.
“Gamidor Diagnostics has a long-standing legacy in Women’s Health, specializing in cervical cancer diagnostics and HPV testing. Recognizing the crucial importance of eradicating cervical cancer and other HPV-related cancers, we are committed to incorporating advanced technologies, such as those offered by Self – screen, to achieve this goal”, says Michal London, Senior Vice President at Gamidor Diagnostics.
“Self-screen is delighted to partner with Gamidor Diagnostics supporting market access in Israel with our effective innovations. Both our companies share a long history and great experience in HPV diagnostics, so this partnership strengthens our joint ambitions in the field of cervical cancer prevention”, 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 such as in Hologic ThinPrep®, which is widely used in Israel, as well as for self-collected samples. The self-sampling option has the potential to significantly improve compliance rates among those who do not currently respond to screening programs and follow-up care.
Please contact Gamidor 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. www.self-screen.nl
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 Gamidor
Gamidor Diagnostics is a medical diagnostic company that provide high-quality diagnostic solutions , systems, reagents and services to clinical laboratories, hospitals, academic research institutes and the public in Israel. The Company’s team consists over 100 professional and skilled employees and it strives for long lasting, friendly and open relationships with its customers and suppliers. Gamidor Diagnostic’s core fields are Women’s Health, Genetics, Tissue Diagnostics, Clinical Chemistry, Lab Automation, Microbiology, Quality control programs, Point of Care and Molecular Biology. www.gamidor.co.il/en/