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:
- Micro-RNA technology
- Enzyme-linked immunosorbent assay (ELISA)
- Immuno-turbidimetric assay
- DNA-based technology
- End-point assay
- Coagulation instrumentation
- Chromogenic method
- Fluorescent in situ hybridization (FISH) technology
- Chemiluminescence
- Microfluidic technology
- Nucleic acid amplification technologies (NAAT)
- Plasma inducible nitric oxide synthase (iNOS)
- Reagents for nucleic acid detection
- Monitoring disease progress and response to therapy