NEW YORK (GenomeWeb News) – PharmiGene said today that the Department of Health in Taiwan has granted the firm approval to market its PG 1502 DNA detection kit on the island.
The test is used to identify patients at greater risk for carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis, which are life-threatening adverse drug reactions. Carbamazepine is an anti-convulsant and mood-stabilizing drug used to treat epilepsy, biopolar disorder, and schizophrenia, among other conditions.
Last year, Taiwan’s DOH and the US Food and Drug Administration updated carbamazepine’s label to state that patients that have the HLA-B*1502 gene may be at higher risk of the two adverse reactions.
“With 40,000 new users of this drug every year in Taiwan alone, our kit will surely reduce this risk for a large number of patients,” PharmiGene CEO Jerome Shen said in a statement.
Taipei, Taiwan-based PharmiGene did not say whether it intends to seek FDA clearance of the test.