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Nanostics Gets CE-IVD Mark for Prostate Cancer Test

NEW YORK – Nanostics said on Tuesday that it has obtained a CE-IVD mark for its ClarityDx Prostate test. The certificate will allow the Edmonton, Canada-based company to offer its blood-based test in Europe.

ClarityDx relies on an algorithm that generates a risk score for clinically significant prostate cancer based on biological and clinical biomarkers obtained from patient blood. The firm said the test should be used for men with high levels of prostate specific antigen to determine whether they require a biopsy.

CEO John Lewis in a statement called the CE-IVD marking a "regulatory milestone" for the ClarityDx Prostate test.

The company also reported positive results from a clinical validation study of ClarityDx Prostate in 1,500 men, and claimed the test showed 94 percent sensitivity and 37 percent specificity in the study.

Nanostics has been developing ClarityDx Prostate for several years. The test was developed in part by researchers from the Alberta Prostate Cancer Research Initiative.