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 over the last years. 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.
“The launch of the Clean Cell Free DNA Kit, our first CE-IVD product, marks a milestone for our company. Our hard work has led us to this moment, and we are fully prepared to position CleanNA within the molecular diagnostics market," commented Glenn Nohar, owner and CEO of CleanNA.
After obtaining the EN-ISO 13485 certificate last March, this is the second large achievement of the company within one year. This trend will be continued with the development of other CE-IVD marked kits that can support establishment and automation of more diagnostic workflows. The launch of the Clean Cell Free DNA Kit is the first in a range of products CleanNA intends to launch in the upcoming years.