MDxHealth SA (Euronext Brussels: MDXH.BR), announced that SelectMDx®, the Company’s non-invasive ‘liquid biopsy’ test that helps to identify patients at increased risk of having aggressive prostate cancer, has been included in the 2018 European Association of Urology (EAU) guidelines.
The EAU guidelines assist clinicians in making informed treatment decisions, taking into account the available scientific data. The inclusion of SelectMDx in the EAU guidelines will enable adoption of the test in EU member states specific guidelines and contribute to drive payor adoption.
Dr. Jan Groen, Chief Executive Officer of MDxHealth, commented: “This is an important milestone for MDxHealth, in line with our strategy to increase the adoption of SelectMDx in Europe and the US. The inclusion in the EAU guidelines is an important recognition of the clinical value of SelectMDx as a non-invasive method of identifying men at high risk of having the aggressive and potentially lethal form of prostate cancer and men at low risk who may forego a painful biopsy, preventing over diagnosis and over treatment.”
SelectMDx is available in the US and all EU member states. Since the introduction of the SelectMDx test mid 2016, over 15,000 patients have been tested and 15 commercial contracts were signed with US based insurance companies.
SelectMDx is based on mRNA biomarkers isolation from urine. The presence of two proprietary biomarkers, HOXC6 and DLX1 mRNA levels, is assessed to provide an estimate for the risk of both the presence of prostate cancer on biopsy as well as the presence of high-risk prostate cancer. In the Clinical Diagnosis paragraph of the new guidelines, The EAU Prostate Cancer (PCa) Guidelines Panel stated that “based on the available evidence, some biomarkers could help in discriminating between aggressive and non-aggressive tumours, with an additional value compared to the prognostic parameters currently used by clinicians.”[i]