Nanostics Gains CE-IVD Mark for ClarityDX Prostate Test

Nanostics has received a CE-IVD mark for its ClarityDX prostate test.

The test identifies biomarkers and generates a risk score for clinically significant prostate cancer. Clinically significant cancer is defined as Gleason grade group 2 or higher.

The test is intended to be used as a reflex test for men with elevated levels of prostate-specific antigen and is designed to help physicians decide whether to proceed with a biopsy.

The test demonstrated 94 percent sensitivity in detecting clinically significant prostate cancer in a recent validation study, the company said.