ResearchDx and Prostatype Genomics Inc. in CLIA-laboratory agreement for the US-market
Prostatype Genomics Inc. and ResearchDx, Irvine, California, USA, has entered into an agreement where ResearchDx fully integrated clinical laboratory PacificDx will perform and run the Prostatype®-test in the US-market.As previously communicated, Prostatype Genomics will offer its prognostic biomarker for diagnosed prostate cancer as a so called LDT-product in USA – similar to comparable products currently offered and reimbursed in USA. LDT stands for “Laboratory Developed Test” meaning that the product can be offered without an FDA-approval. What is required is a partnership with a CLIA-