Validation of a genetic test for detection of HLAB*1502 / Azraan Zakariah

The person-to-person variability of drug responses a major problem in clinical practice and drug development which may leads to adverse drug reactions
(ADRs). HLA-B gene associated with ADRs include hypersensitivity to carbamazepine and phenytoin, the most common causes of antiepileptic drugs induced cutaneous adverse reactions, Stevens-Johnson syndrome. Therefore, Food and Drug Administration (FDA) had recommended genetic screening of HLAB* 1502 in patients prior to initiation of carbamazepine or phenytoin therapy. PCR genotyping kit has been developed by a team of researchers in Pharmacogenomics Centre (PROMISE) to detect the presence of HLA-B*1502 allele. The genotyping kit for detection of HLAB*1502 needs to be validated because it has become an important part for acceptance of a new diagnostic method as required by the OECD and ICH. The genotyping kit needed to prove its reliability and relevance for its ability to detect HLAB*1502. Therefore, in this study, a validation strategy has been planned and tested based on several international guidelines.