CleanNA, a Dutch manufacturer of magnetic bead-based nucleic acid extraction kits, has launched its first CE-IVD certified product. The ‘Clean Cell Free DNA Kit’ helps to isolate cell-free DNA from human plasma in three straightforward steps: bind, wash and elute. With its magnetic bead technology and CE-IVD mark, the kit is ideal for automation and use in diagnostic procedures.
Cell-free DNA has gained a huge amount of interest in the medical world. These small pieces of genomic DNA are present in the bloodstream and can be of great help in diagnostic procedures. An advantage of this diagnostic tool is that it is minimally invasive for the patient, because only a blood sample is necessary, instead of for example a surgical biopsy. Fields where the Clean Cell Free DNA Kit can be used include prenatal screening, oncology, transplant medicine, and cardiovascular diseases.
For a product to be used in a diagnostic pipeline, it needs to be CE-IVD marked. The In Vitro Diagnostic Regulations of the European Union have the goal to ensure that products are safe, effective and reliable and they apply to all in vitro diagnostic medical devices and their accessories on the EU market. To demonstrate compliance, the manufacturer must compile a technical file with documents of proof, such as a performance review report, a risk analysis report and a post-market surveillance report. The product will be carefully monitored after its launch as well, to ensure continuous compliance to the IVDR.