Diagnostics device for rapid testing of prostate cancer at point-of-care
Prostate cancer (PCa) is one of the most common types of cancers. As an age-related disease, it is very infrequent below the age of 40 but very common above 65. Currently in Europe, 1 in 7 men will develop PCa before reaching age of 85. With population growth and ageing, the numbers of PCa diagnoses and PCa deaths are likely to substantially increase. It is estimated that by 2030, with an increase in the proportion of people over 65, the number of PCa cases will quadruple. Most PCa’s are first found through a prostate-specific antigen (PSA) blood test. Under the current standard of care, men with an elevated PSA levels and/or abnormal digital rectal exam (DRE) are considered at high risk for cancer and will be referred to a urologist for a biopsy. But most men selected for biopsy could have avoided this painful procedure, with its associated complications and costs. More accurate non-invasive tests could help PCa-free men safely avoid unnecessary biopsies, while helping to identify men who may be harbouring aggressive PCa, who will benefit from earlier detection. In response to this challenge, we have developed Nevada, a non-invasive urine-based test assay that identify those men at increased risk of PCa who may benefit most from earlier detection. We plan to convert our test into a Point of Care assay, resulting in significant savings for the healthcare systems across Europe, by only referring those patients to the hospitals that are at risk for a clinically significant cancer. Upon completion of the project, Nevada will boost the growth of our company generating additional 85 FTEs, revenues of €309M and a ROI of 7.9 by the fifth year after Phase 2 execution. With the help of the SME instrument, MDxHealth aims to complete clinical validations and assay optimization so that it can be commercialized across European markets first, and global markets later on, improving the quality of care of healthcare systems worldwide as well as the PCa patient´s quality of life.