Nalagenetics has just completed CE-marking for one of the reporting modules of its Clinical Decision Support (CDS) software.
The registration enables its software to be marketed in Europe and support further approval in Southeast Asia, where it aims to gain market share.
Nala Clinical Decision Support™ Module – PGx Core is a companion software to its qPCR kit, Nala PGx Core(R) , which genotypes top pharmacogenes to help providers run pre-emptive pharmacogenomics programs in a cost-effective manner.
qPCR is the workhorse of clinical genomics, and it has been made widely available with the recent COVID-19 testing requirements. Due to the recently added genotyping capacity globally, and uptake of genomic screening for prevention, the kit is uniquely positioned to support the democratization of personalized prescription.
Nala CDS™ Module-PGx Core and PGx Core qPCR kit are used together as a plug-and-play solution for labs with qPCR machines. The kit, which is a Research Use Only kit, reads 20 variants within 4 known pharmacogenes, CYP2D6, CYP2C9, CYP2C19, and SLCO1B1, and the software can generate up to 170+ drug-gene reports.
Based on studies in Singapore, 8% of local hospital admissions are caused by adverse drug reactions. Adverse drug reactions are also the fourth largest cause of death in the US. Pharmacogenomics-guided prescriptions have been urged to be adopted widely in the UK and by NHS.
One of the largest barriers for the implementation of pharmacogenomics is cost-effectiveness, especially in emerging markets. Many drugs that need to be personalized are old, generic drugs. Despite this, 88% of implementation studies have been proven cost-effective, though majority of the studies are still limited to developed markets.
“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,” says CEO Levana Sani.
Nala CDS™ is expanding into other use cases beyond pharmacogenomics, with partnerships with sequencing partners.