NEW YORK – Finnish startup Nadmed said on Thursday that it has obtained CE-IVD marking for its Q-Nadmed kit for the analysis of nicotinamide adenine dinucleotides (NADs), a class of metabolites.
The test is used for analyzing oxidized and reduced types of NAD metabolites, NAD+ and NADH.
The firm received the certificate under Europe's In Vitro Diagnostic Directive (IVDD), which was in effect until May 26, when the new In Vitro Diagnostic Regulation came into force. The certificate will remain valid for several years, as Europe transitions to the IVDR.
Helsinki-based Nadmed's technology relies on a cyclic enzymatic reaction followed by colorimetric detection. The intensity of the assay's color change corresponds to the quantity of metabolites. The assay can be run on standard laboratory equipment, the firm said.
"We believe the Nadmed method will advance science and medical practice by enabling larger and quicker clinical trials and, in due course, diagnostics," CEO Järi Närhi said in a statement. "NAD measuring should be seen as a first-line diagnostic tool in the future to fight, for example, degenerative diseases and metabolic disorders," he said.
The company noted that its technology has been used in recent studies at the University of Helsinki to monitor the response of patients with mitochondrial muscle disease and NAD deficiency to NAD booster treatment.