EC Clears PCR-Electrophoresis Assay Platform and C. Diff Test
PrimeraDx’s IcePlex quantitative multiplex PCR system and C. difficile detection assay were both awarded a European CE mark. The technology exploits the firm’s clinical platform that combines PCR with capillary electrophoresis.
PrimeraDx is developing a range of assay for its IcePlex system, spanning infectious diseases, oncology, and companion diagnostics. The firm’s IcePlex system is based on its STAR technology, which uses sequential sampling of PCR products and capillary electrophoresis detection for quantitative detection, and the capacity to measure up to 60 analytes in a single sample. PrimeraDx currently has a pipeline of assay kits that are in various stages of development and regulatory approval.
The firm’s aim is both to sell the system in open platform mode to clinical laboratories, and also to collaborate with the pharmaceutical industry for the development of companion and enabling diagnostics. It claims the IcePlex technology can be used to design complex multi-modal assays for disparate target types, including SNPs, expression biomarkers, microRNAs, and fusion genes.
“Obtaining the CE mark on our instrument and assay is an important step in the process of global commercialization of our extensive pipeline of molecular diagnostics products in infectious disease and oncology,” comments president and CEO Matt McManus, Ph.D. "The CE mark demonstrates to current and future customers, and strategic partners, our ability to develop and support high-quality diagnostic products.”