Dx Assays

Dx assays enables individualized healthcare solutions by providing advanced molecular diagnostic assay development and validation services. Core expertise is in quantitative real-time PCR assay development. The company’s state-of-the-art laboratories offer a large portfolio of leading technology platforms, operate in a GLP-compliant environment ISO13485 certified. Proven track record: more than 10 R&D projects, valued at several million dollars successfully completed for diagnostic clients Timely and accurate project execution Expert scientific team and rigorous quality management: glp and ISO13485 compliance Reliable diagnostic development expertise based on international standards Broad collection of technology platforms in a state-of-the-art MDx laboratory: Nucleic acid extraction technology from market leader QIAGEN. 3 major real-time PCR platforms (ABI, Roche, Corbett Research) and Luminex technology available for assay development Assay development from sample to result on a wide range of platforms: • Advice on most suitable platform. • Parallel development on multiple platforms. • Comparative evaluation Milestone driven fee-for-service business model and lean project management with short decision trees Low risk and without long-term investment and fast execution with minimal turn-around times from concept to result Commitment to unprecedented levels of customer service Flexibility from RUO type projects to full IVD-scale test developments. Resources assigned ‘as-needed’ including overseas assignments Dx assays works with pharma to qualify biomarkers, enabling companion diagnostic development – and to enhance existing assays, facilitating confident decision making. In addition, the company’s services extend R&D capacity and accelerate time-to-market in biotech settings. Services offered: * Development and validation services of nucleic-acid based tests * Assay development in Infectious Disease, Oncology, Genetic Testing * Biomarker qualification * Assay development and guard banding * Validation and verification * Claim extension (IVD)