Biotechnology firm Nalagenetics has obtained CE Mark for its pharmacogenomics software, Nala Clinical Decision Support (CDS) Module-PGx Core.
The CE Mark will allow the company to market its CDS software in Europe and obtain regulatory approval in Southeast Asia, where it intends to increase its market share.
Nalagenetics stated that Nala CDS Module-PGx Core is a companion software to its Nala PGx Core qPCR kit, which genotypes top pharmacogenes to assist providers in running pre-emptive pharmacogenomics programmes economically.
For labs using qPCR machines, the Nala CDS Module-PGx Core and PGx Core qPCR kit can be used together as a plug-and-play solution.
The research-use-only kit reads 20 variants in four known pharmacogenes, including CYP2D6, CYP2C9, CYP2C19 and SLCO1B1, while the software can create up to 170 drug-gene reports.
Nalagenetics noted that the kit is currently being validated with its partners in the UK and Malaysia.
Nalagenetics CEO Levana Sani said: “We are very excited about this milestone to build credibility in the European and home market in South East Asia.
“With pharmacogenomics testing becoming more and more ubiquitous around the world, it requires standardised and robust tools to support the rapid increase of adoption.”
qPCR is the base of clinical genomics. It has become widely available recently due to Covid-19 testing requirements.
The kit is positioned to assist the democratisation of personalised medication due to newly added genotyping capacity across the world, as well as the proven benefit of pharmacogenomics for mass screening of populations.
In collaboration with sequencing partners, Nala CDS is expanding into new applications beyond pharmacogenomics.