DLC has significant experience in performance evaluation studies for IVDs. Over the last five years, DLC has managed a large IVD study with over 2,000 subjects enrolled at 12 sites across Europe, US and Canada. Additionally, DLC has provided full clinical services for a smaller study with over 140 subjects enrolled at 3 sites in Europe and US. For both studies DLC regulatory support included the preparation of 510(k) submissions to FDA.
Other performance evaluation studies undertaken by DLC include:
Enzyme-linked immunosorbent assay (ELISA)
Fluorescent in situ hybridization (FISH) technology
Nucleic acid amplification technologies (NAAT)
Plasma inducible nitric oxide synthase (iNOS)
Reagents for nucleic acid detection
Monitoring disease progress and response to therapy