CleanNA introduces CE-IVD compliant CleanNGS Dx

WADDINXVEEN, Netherlands--(BUSINESS WIRE)--CleanNA, a leading Dutch manufacturer of magnetic bead-based nucleic acid extraction kits and systems, launched a CE-IVD compliant version of their flagship product, CleanNGS. The single-component reagent CleanNGS Dx is highly suitable for nucleic acid (library) cleanup and (double-sided) size selection in preparation for Next-Generation Sequencing (NGS) applications in clinical diagnostic settings.

Next-Generation Sequencing is rapidly becoming more prevalent in clinical diagnostics due to its advancements and decreasing costs. This powerful technology is used for applications such as identifying genetic disorders, detecting cancer mutations, and tracking infectious diseases. Before NGS can be successfully performed, nucleic acid size selection and cleanup processes are essential to ensure the quality and accuracy of sequencing results.

Over the years, CleanNGS has proven to be a reliable product for the purpose of size selection and cleanup of nucleic acids. The brand-new CleanNGS Dx combines all the experience of CleanNGS with a CE-IVD certification, making it perfectly suitable for use in NGS applications within diagnostic workflows. The In Vitro Diagnostic Regulations of the European Union aim to ensure that products are safe, effective, and reliable, and they apply to all in vitro diagnostic medical devices on the EU market.

“The CE-IVD certification of CleanNGS not only ensures compliance with European regulations and market access but, above all, guarantees the safety, effectiveness, and quality of the product. These factors are crucial for reliable human molecular diagnostics.”

- Glenn Nohar, CEO of CleanNA

CleanNGS Dx is CleanNA’s third CE-IVD compliant product launched over the course of a year, after the Clean Cell Free DNA Kit (CE-IVD) and Clean Quick Viral DNA/RNA (CE-IVD). The Dutch company is steadily building its portfolio with products for in vitro diagnostic use.

About CleanNA:

CleanNA is a Dutch manufacturer of nucleic acid extraction kits that are based on an easy bind-wash-elute principle using magnetic beads. Their quality management system is EN-ISO 13485 certified by Bureau Veritas. The company’s product portfolio exists of extraction kits for nucleic acids from clinical samples for 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.