Isohelix is pleased to announce that its GeneFiX™ Saliva DNA Collection Device has received CE-IVD marking, through completion of a comprehensive technical validation under the European Directive for In Vitro Diagnostic Medical Devices.
GeneFiX™ stabilizes DNA at room temperature for at least 36 months, using a unique and specifically developed DNA stabilization buffer that maximises DNA yields, yet allows easy and high purity integration into most downstream isolation processes. The sampling process is highly intuitive and gives considerable flexibility for using various saliva volumes and tube types, from both manual to automated high throughput. The device has various features to prevent accidental spillages yet is easy to use, and in an ideal format for transport and storage.
“Receipt of the CE-IVD mark is indicative of the quality of the design and development of the GeneFiX™ Saliva DNA Collection Device,” said Tom Hole, CEO, Isohelix. “Achieving this regulatory milestone is a major step forward in assuring labs and clinicians can have the confidence in GeneFiX™ to stabilize the sample at point of collection, resulting in optimal sampling for a variety of subsequent downstream processes.”
The CE-IVD marked GeneFiX™ Saliva Collection Device is available in the European market immediately.
Isohelix Ltd is a division of Cell Projects Ltd, which specializes in the development and manufacture of innovative high quality DNA Sampling and Purification products for the Life Science Research, Molecular Diagnostics and Forensic markets. The Isohelix products include DNA Swabs, DNA Saliva Collection devices and many DNA Isolation, Stabilization and associated kits.
Cell Projects also manufactures products used for Electroporation, PCR, qPCR, Transfection and Electrophoresis, alongside this Isohelix also has a thriving sub-contract and services business providing considerable expertise in product design, regulatory, safety and commercial market knowledge to its customers.