ClassiX™ DNA/RNA Receives CE-IVD Marking: One Flexible, Robust Chemistry for 7 Clinical Sample Types and 9 Organism Classes
05.11.2026, Hallbergmoos, Germany. Xpedite Diagnostics GmbH today announces that ClassiX™ DNA/RNA, the “universal” extraction kit launched for Research Use Only on 17 September 2026, is now CE-marked as an in vitro diagnostic device (REF CXDR-96-IVD), registered as a Class A device according to (EU) 2017/46 (In vitro Diagnostic Medical Devices Regulation, IVDR).
Flexibility One chemistry and one protocol cover 7 clinical relevant sample types, including whole blood, serum, stool, urine, semen, respiratory, urogenital and rectal swabs, and 9 organism classes, from Gram-positive and Gram-negative bacteria to RNA and DNA viruses, fungi and parasites. DNA and RNA are co-purified from a single input, manually or fully automated on SwiftXtractor™ SL. ClassiX™ DNA/RNA can also be universally applied to virtually any liquid handling platform that has in-built magnetic separation capability.
Robustness Developed for the most difficult matrices, ClassiX™ DNA/RNA delivered earlier detection (lower Cq values) than commercial reference kits from whole blood and stool, two of the most inhibitor-rich sample types in molecular diagnostics, with no inhibition across a 32-sample fecal panel. Reagents are stored at room temperature, with no cold chain required.
Clinical performance In a clinical performance evaluation of 123 samples, comprising 110 clinical specimens and 13 spiked specimens across seven human sample types, the IVD kit showed a diagnostic sensitivity of 97.2% and a specificity of 100%. Under its CE-IVD intended use, ClassiX™ DNA/RNA is indicated for professional manual and automated extraction from human sample types.
“Our objective was a single, universal chemistry that performs consistently across every matrix a laboratory encounters, rather than another kit optimized for one,” said Dr. Andy Wende, Founder and Managing Director of Xpedite Diagnostics GmbH. “With CE-IVD marking, clinical laboratories can now bring that same chemistry into routine diagnostics, instead of maintaining a separate extraction workflow for each specimen type.”
ClassiX™ DNA/RNA (CXDR-96-IVD) is available from today in the European Union and in markets that recognize CE marking. Instructions for Use, performance data and ordering information are available on the product page.
About Xpedite Diagnostics GmbH
Xpedite Diagnostics GmbH is a German molecular diagnostics company developing rapid, smart and sustainable nucleic acid extraction technologies. The company operates under an ISO 13485:2016-certified quality management system. Its portfolio includes CE-marked IVD products for clinical diagnostics, as well as solutions for environmental surveillance and life science research.
Media Contact
Xpedite Diagnostics GmbH
Lilienthalstr. 2A, 85399 Hallbergmoos, Germany
[email protected] | +49 811 998 538 10 | www.xpedite-dx.com