The ClarityDX Prostate test offers patients and doctors an accurate prediction of clinically relevant prostate cancer for better decision-making and enhances health outcomes
Nanostics has secured the CE-IVD Mark for its ClarityDX Prostate test. (Credit: Michal Jarmoluk from Pixabay)
Precision health diagnostics company Nanostics has secured the CE-IVD mark for its ClarityDX Prostate test for prostate cancer detection.
The ClarityDX Prostate test offers patients and doctors an accurate prediction of clinically relevant prostate cancer for better decision-making and enhances health outcomes.
The approval will enable Nanostics to promote and offer ClarityDX Prostate in Europe and other nations that demand the CE mark to access the market.
The ClarityDX Prostate test generates a risk score for clinically relevant prostate cancer, which is defined as Gleason grade group 2 or higher, based on data from biological and clinical biomarkers.
The test is intended to be used as a reflex test for men with increased PSA levels and is made to assist doctors and patients in making an informed choice regarding biopsy.
Nanostics CEO John Lewis said: “We’re excited to reach this regulatory milestone for our ClarityDX Prostate test built on our robust biomarker and machine learning platform.
“Using ClarityDX Prostate as a reflex test for men with elevated PSA levels will help physicians, patients, and their families make more-informed decisions on how best to proceed with prostate cancer screening and result in better health outcomes for men with prostate cancer.”
The test’s clinical validation trial with 1,500 patients yielded 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for diagnosing clinically severe prostate cancer.
Implementation could lower the number of pointless biopsies by up to 37% and the number of pointless treatments for prostate cancer, said the Nanostics.
The achievement of the CE-IVD and compliance with applicable EU law demonstrate the firm’s dedication to creating in vitro diagnostic medical devices that adhere to strict regulatory standards.
The company said that it will expand its regulatory portfolio to provide market access in various sectors.