made by True Diagnostics Inc. that determines PSA level from a finger prick of blood has received the CE mark, the company announced. Because it doesn’t require an IV blood draw, the TrueDX PSA test gives doctors the ability to make diagnoses in minutes instead of days, according to the company. True Diagnostics has begun working with distributors in the EU, focusing initially on France, Germany, Italy, Spain, and the United Kingdom.
The company has already received the CE mark for its TrueCX PSA, a qualitative OTC test for antigen levels greater than 5.0. This new mark is the third regulatory approval for the TrueDX Platform, says the San Diego–based company. The TrueDX TSH test has received a CE mark and has been approved for use in China. The company plans short U.S. clinical studies with the TrueDX Platform in 2013. It has plans to apply for a CLIA waiver and 510(k) clearance in order to sell the technology in the U.S. Targeting the POC market, the platform offers tests with a 24-month shelf life and no refrigeration requirement, True Diagnostics says. It is designed for detecting a range of biomarkers, including those for Alzheimer’s disease, autism, cancer, diabetes, and drugs of abuse.