What is the POLARIS Nalagenetics TEST?
The POLARIS Nala RxReact Siponimod Test is an in vitro diagnostic assay developed in the Laboratory and performed on the Bio-Rad CFX96 Real-Time PCR Detection System (CFX96) using DNA isolated from buccal swabs. It indicates the presence or absence of 2 specific Single Nucleotide Polymorphism variants of the Cytochrome P450 2C9 enzyme (CYP2C9 SNPs), as detected by the CFX96 based on established fluorescence and cycling thresholds.
How are test requestors assured of the quality of the POLARIS Nalagenetics Test?
The POLARIS Nala RxReact Siponimod Test was developed and validated in accordance with the College of American Pathologists (CAP) and Ministry of Health (MOH), Singapore, guidelines, within the CAP-accredited and PHMC licenced POLARIS Laboratory at Genome Institute of Singapore (POLARIS@GIS). A Clinical Report is issued within 5 working days upon sample receipt, with details regarding the presence or absence of the 2 CYP2C9 SNPs as well as the indication for the use of Siponimod in accordance with FDA guidelines.
How will the POLARIS Nalagenetics Test results affect diagnosis and treatment options?
The CYP2C9 enzyme plays a key role in the metabolism of Siponimod (MAYZENT®, Novartis), an FDA-approved sphingosine 1-phosphate receptor modulator indicated for treating relapsing forms of multiple sclerosis. The US Food and Drug Administration (FDA) recommends CYP2C9 genotype profiling prior to initiating Siponimod treatment, and has released guidelines on initiation schedules and maintenance dosage of the drug. The POLARIS Nala RxReact Siponimod Test is validated for identifying the presence of CYP2C9*2 and CYP2C9*3 variants with 100% accuracy and specificity and is used for guiding clinical use of Siponimod in accordance with FDA guidelines.
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