Self-screen’s HPV Risk Assay recommended to the Uruguayan Ministry of Health for cervical cancer screening.
Montevideo, Uruguay and Amsterdam, The Netherlands – March 5, 2025: Upon a recent request to evaluate clinically well validated hrHPV Test for the use of HPV screening in Uruguay, Self-screen’s HPV Risk Assay is recently recommended to be added to the HPV list for primary screening. This recommendation is the result of the consultation of both international and national expert groups. In the international community that publishes yearly updates of the HPV assays that comply to the International Guidelines (also known as the Meijer criteria), HPV Risk Assay is listed among the first generation of validated assays since 2014.
Upon the new cervical screening that is being rolled out now in Uruguay by primary HPV screening, also national experts dra. Laura Garcia and dra. Gabriela Moreira have forwarded the recommendation to the Ministry of Health to list HPV Risk Assay. A great achievement for the country during this week which marks the International HPV Awareness Day on March 4th.
Every year, more than 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. Uruguay is among the leading countries implementing HPV testing as primary screening methodology and based on the recently approved guidelines is implementing HPV screening in 2025. with progressing cervical disease in direct need for colposcopy or other follow-up procedures.
In Uruguay HPV Risk Assay is distributed by Biodiagnostico, a company with a long history in molecular diagnostics and a focus in Women’s Health. Clinics and laboratories interested in offering the recommended HPV Risk Assay can contact Biodiagnostico.
“Biodiagnostico has a long-standing legacy in Women’s Health in Uruguay and is well known for its outstanding expertise in molecular diagnostics by which they support many public and private laboratories, thereby supporting them 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 well validated and recognized assays and advanced technologies, such as those offered by Self – screen, to achieve this goal”, says Sofía Lazaneo, Commercial Manager at Biodiagnostico.
“Self-screen is delighted to partner with Biodiagnostico supporting market access in Uruguay. Both our companies share a long history and great experience in HPV diagnostics, so this partnership strengthens our joint ambitions with our effective innovations in the field of cervical cancer prevention”, says Michelle Meijer, Chief Commercial Officer at Self-screen B.V. ”Furthermore in triaging HPV positively screened women, our methylation test PreCursor-M+ 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.”
Both HPV Risk Assay and the PreCursor-M+ test are 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 Biodiagnostico 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 Biodiagnostico
Biodiagnostico is a leading company specializing in the distribution of instruments and reagents for clinical laboratories as well as transfusion medicine and life sciences. Established in Uruguay in 2003, the company initially focused on high-specificity diagnostic solutions. Over the years, it has expanded to become one of the most recognized providers in the country.
Committed to quality and exceptional customer service, all processes are certified under the LSQA ISO 9001:2015 standard and a significant portion of its team consists of highly trained technical service professionals, ensuring world-class support for its clients.
Biodiagnostico Uruguay is part of Biodiagnostico Group, the South Cone’s N°1 distribution hub for laboratory instruments and reagents, with operations in Argentina, Uruguay, and Paraguay.
