CleanNA Enters the Molecular Diagnostics Market by Launching Its First CE-IVD Product
CleanNA, a Dutch manufacturer of magnetic bead-based nucleic acid extraction kits, launched its first CE-IVD marked product. Their ‘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 within the European Union, it needs to be CE-IVD marked. The In Vitro Diagnostic Regulations have the goal to ensure that products are safe, effective and reliable. To demonstrate compliance, the manufacturer must compile a technical file with a performance review report, risk analysis report, post-market surveillance report and more.
“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.”
– 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. The launch of the Clean Cell Free DNA Kit is the first in a range of CE-IVD marked products CleanNA intends to launch in the upcoming years.
CleanNA is a Dutch manufacturer of magnetic bead-based nucleic acid extraction kits, with an EN-ISO 13485 certified quality management system. The company’s product portfolio exists of nucleic acid extraction kits for use in research and diagnostics, and for sample cleanup during PCR or Next Generation Sequencing procedures. Due to the use of magnetic beads, the products are ideally suited for use in automated extraction procedures.
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