All Exymes products are designated Research Use Only. This is worth explaining, because it is sometimes misread as a limitation when it is more accurately a positioning decision that has direct implications for how labs can use the chemistry.

RUO means the products have not been validated for use in clinical diagnostics under IVD regulation. It does not mean the chemistry is less rigorous, less validated, or less reliable than regulated products. It means the regulatory pathway that would be required to make a clinical diagnostic claim has not been pursued.

For research laboratories, forensic labs, agricultural testing, environmental monitoring, and food safety applications, this is not a constraint. Most downstream molecular analysis e.g. STR profiling, SNP genotyping, NGS library preparation, qPCR assays, RT-PCR is performed using RUO reagents throughout.

What RUO designation does shift is responsibility: the laboratory using the kit is responsible for validating it in their specific application, with their specific sample types and downstream assays. This is standard practice in research and applied molecular biology.

For labs building new workflows, this is also an opportunity: Exymes can discuss your specific application, provide relevant application note data, and supply evaluation kits.