CleanNA, a leading Dutch manufacturer of magnetic bead-based nucleic acid extraction kits, has unveiled a CE-IVD compliant version of its flagship product, CleanNGS. The new CleanNGS Dx reagent is designed for nucleic acid cleanup and size selection, specifically for next-generation sequencing (NGS) applications in clinical diagnostics.
As next-generation sequencing becomes more prevalent in clinical settings due to technological advancements and lower costs, the need for accurate nucleic acid size selection and purification is crucial for reliable sequencing results. CleanNGS has earned a reputation for effective size selection and cleanup, and the CleanNGS Dx version now offers CE-IVD certification, making it suitable for diagnostic workflows.
The CE-IVD certification ensures compliance with European regulations, focusing on product safety, efficacy, and quality—essential for reliable human molecular diagnostics.
“We are proud to introduce CleanNGS Dx as our third CE-IVD compliant product within a year,” stated Glenn Nohar, CEO of CleanNA. The company previously launched the Circulating Free DNA Kit and the Rapid Viral DNA/RNA Extraction Kit, continuing to expand its in vitro diagnostic product portfolio.
About CleanNA:
CleanNA specializes in nucleic acid extraction kits using the bind-wash-elut principle with magnetic beads. Certified under EN-ISO 13485 by Bureau Veritas, CleanNA’s products are well-suited for automated extraction in research and diagnostics, particularly during PCR and NGS procedures.
