On August 23, 2022 Nanostics Inc., a precision health diagnostics company, reported that it has received the CE-IVD Mark for its ClarityDX Prostate test (Press release, Clarity Pharmaceuticals, AUG 23, 2022, View Source [SID1234618584]). This regulatory milestone allows Nanostics to market and sell ClarityDX Prostate in Europe, as well as other countries that require the CE Mark for market access.
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The ClarityDX Prostate test uses a proprietary machine-learning algorithm that combines data from biological and clinical biomarkers to generate a risk score for clinically significant prostate cancer, defined as Gleason grade group 2 or higher, on prostate biopsy. The ClarityDX Prostate test is intended to be used as a reflex test for men with elevated levels of PSA and is designed to help physicians and patients make a more informed decision on whether to proceed with a biopsy or not.
"We’re excited to reach this regulatory milestone for our ClarityDX Prostate test built on our robust biomarker and machine learning platform," said John Lewis, CEO of Nanostics. "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."
Recently, Nanostics announced positive results from its 1,500-patient clinical validation study of its ClarityDX Prostate test, showing 94% sensitivity, 37% specificity, 49% positive predictive value, and 90% negative predictive value for predicting clinically significant (grade group ≥2) prostate cancer. Implementation could eliminate up to 37% of unnecessary biopsies and significantly reduce the number of unnecessary treatments for prostate cancer.
Compliance with the relevant EU legislation and attainment of the CE-IVD mark represents Nanostics’ commitment to developing and marketing in vitro diagnostic medical devices that meet stringent regulatory requirements. Nanostics is committed to expanding its regulatory portfolio to allow for market access in different jurisdictions.