True Diagnostics obtains CE mark for quantitative prostate specific hormone test

TrueDXPSA test will enable doctors to rapidly determine the PSA level in a patient.

True Diagnostics president and CEO Jerry Lee said, "With our TrueDX™PSA, the Company provides general practitioners, urologists, and oncologists with a simple point-of-care tool they can use to measure their patients’ prostate health immediately."

At present, the company is in the process of establishing a distribution network across all EU markets with initial focus in Germany, UK, France, Italy and Spain.

The company has earlier obtained CE Mark for its TrueDXTSH test and an sFDA approval for TrueDXTSH in China.

Short clinical studies are expected to be conducted in the US to submit for CLIA-waive and 510k FDA clearances for the marketing of TrueDX Platform in the country.

TrueCXPSA, the company’s qualitative PSA test, earlier obtained CE mark as a quick screen for other-the-counter use to find out PSA levels greater than 5.0.