Tuesday, November 07, 2023
CleanNA, a Dutch company specializing in magnetic bead nucleic acid extraction kits, has launched its first CE-IVD certified product, the "Clean Cell Free DNA" kit. This kit simplifies the process of isolating cell-free DNA from human plasma with a straightforward three-step procedure involving ligation, washing, and elution.
Cell-free DNA has gained substantial attention in the medical field in recent years. These small genomic DNA fragments can be found in the bloodstream and are highly valuable for diagnostic purposes. One of the key advantages of this diagnostic tool is its minimally invasive nature, as it only requires a blood sample, eliminating the need for surgical biopsies. The Clean Cell Free DNA kit has applications in various medical areas, including prenatal screening, oncology, transplant medicine, and cardiovascular diseases.
In order for a product to be used in a diagnostic pipeline within the European Union, it must be granted CE-IVD marking. The regulations for in vitro diagnostics are in place to ensure the safety, effectiveness, and reliability of these products. To demonstrate compliance with these regulations, manufacturers must compile a comprehensive technical dossier, which includes a performance evaluation report, risk analysis report, and post-market surveillance report, among other documentation.
The introduction of the Clean Cell Free DNA kit as CleanNA's first CE-IVD product signifies a significant milestone for the company. It reflects their dedication to meeting the stringent standards required for diagnostic use within the European Union.