The CE mark will allow the firm to sell its software in Europe, as well as secure regulatory permission in Southeast Asia, where it hopes to increase its market share
Singapore-based biotechnology company Nalagenetics has received a CE mark for its pharmacogenomics software, Nala Clinical Decision Support Module- PGx Core.
The CE mark will allow the firm to sell its software in Europe, as well as secure regulatory permission in Southeast Asia, where it hopes to increase its market share.
Nala Clinical Decision Support Module- PGx Core is a companion software to the Nala PGx Core qPCR kit, which genotypes pharmacogenes to assist providers in running cost-effective pre-emptive pharmacogenomics programmes.
Nala CDS Module-PGx Core and PGx Core qPCR kits are utilised together as a plug-and-play solution for labs using qPCR equipment.
The kit reads 20 variations within four known pharmacogenes, including CYP2D6, CYP2C9, CYP2C19, and SLCO1B1, and the programme can create up to 170 drug-gene reports.
Nalagenetics said that the kit, which is a Research Use Only kit, is now being validated with partners in Malaysia and the UK.
Nalagenetics chief executive officer Levana Sani said: “We are very excited about this milestone to build credibility in the European and home market in Southeast Asia.
“With pharmacogenomics testing becoming more and more ubiquitous around the world, it requires standardized and robust tools to support the rapid increase of adoption.”
With cooperation with sequencing partners, Nala CDS is expanding into new application cases beyond pharmacogenomics.