[At-home tests in the healthcare market-opportunities, limitations, and clear oversight using the example of PSA home...

Mobile health tests are gaining increasing relevance in healthcare systems and address existing gaps in care, including low participation in preventive screening, access barriers, and the growing demand for patient autonomy in health management. In particular, home-based tests, such as those measuring prostate-specific antigen (PSA), offer low-threshold access to preventive care and may serve as an entry point into the medical care pathway.From a urological perspective, however, these potentials are clearly limited. Self-tests provide only isolated measurements and do not replace medical diagnostics or clinical evaluation. Especially in the context of PSA testing, there is a significant risk of misinterpretation: both false-positive results, leading to unnecessary diagnostic cascades, and false-negative findings, creating false reassurance, may compromise patient safety.Key challenges also include pre-analytical limitations, the absence of structured indication, and insufficient integration into established care pathways. Patients are often left alone with potentially critical results, both organizationally and emotionally. Regulatory approval ensures minimum safety standards but does not substitute for structured, quality-assured medical process management.The German Professional Association of Urology (BvDU) critically assesses PSA home testing without mandatory medical involvement. In urology, PSA is not an isolated screening parameter but part of a complex, risk-adapted diagnostic pathway.Home testing is therefore only justifiable if it is systematically integrated into structured, physician-led care pathways. This includes adequate patient information, appropriate indication, professional interpretation of results, and ensured follow-up in case of abnormal findings.In conclusion, mobile tests may represent a valuable access point to healthcare; however, they must not replace medical responsibility. Patient safety must take precedence over market dynamics.