- Nanostics’ biomarker and machine learning-powered test, ClarityDX Prostate®, received a CE-IVD Mark.
- A CE-IVD Mark is required for all in vitro diagnostic (IVD) devices to be placed in the European Economic Area, Iceland, Norway, and Liechtenstein and allows Nanostics to market and sell ClarityDX Prostate® in these countries.
- The ClarityDX Prostate® test provides patients and physicians with an accurate prediction of clinically significant prostate cancer to support decision-making and improve health outcomes for men suspected of having prostate cancer.