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Press Release: Nanostics Receives CE Mark for its ClarityDX Prostate® Test to Detect Clinically Significant Prostate Cancer

  • 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.

Press Release: Nanostics Announces the Launch of its Bladder Cancer Clinical Study Identifying Disease Predictors for Early Detection of Bladder Cancer

  • Clinical study launched in June 2022 with patient recruitment in Alberta with plans to expand to further sites across North America.
  • The aim of the study is to validate a novel and minimally invasive liquid biopsy test for bladder cancer diagnosis using Nanostics’ ClarityDX® diagnostic platform.
  • The study is supported in part by the Alberta Innovates AICE-Concepts Program with a $600,000 award to Dr. John Lewis, Bird Dogs Chair in Translational Cancer Research at the University of Alberta.

Nanostics Re-Opens ClarityDX Prostate Clinical Study with New US Recruitment Site

PR: Nanostics announced the re-opening of their clinical validation study testing ClarityDX Prostate in a real-world setting. The study is also greatly benefiting from further expansion into the US with the addition of a new patient recruitment site at an award-winning United States clinical research institution. ClarityDX Prostate is a novel liquid biopsy test for the early diagnosis of clinically significant prostate cancer. Nanostics is excited to work with this Partner to reach the recruitment numbers and diversity goals of the clinical study.

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