Singapore, Aug 22, 2008: PharmiGene, a pharmacogenetic-based molecular diagnostic company, has received approval from the Department of Health (DOH) in Taiwan to begin marketing the PG 1502 DNA detection kit, one in the line of the company's rapid genetic tests. This test can be used as an aid for clinicians in identifying patients at greater risk of Carbamazepine-induced Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), life-threatening adverse drug reactions (ADR).

 

According to the company this product is the first regulated diagnostic test in the world to determine the ADR risks induced by Carbamazepine.

 

Carbamazepine is an anticonvulsant and mood-stabilizing drug that is used primarily in the treatment of epilepsy and bipolar disorder. It is also used to treat trigeminal neuralgia. However, Carbamazepine is also the most common cause of the serious ADR in Taiwan. Last year, both the DOH and US FDA announced updated Carbamazepine labeling regulations to increase patient awareness regarding the use of drugs and the role of genetics in causing drug toxicity. The new re-labeling explains that those possessing the gene HLA-B*1502 may be at a higher risk of SJS/TEN.

 

CEO of PharmiGene Dr Jerome Shen said, while Carbamazepine is a very effective and successful drug, it can be risky for some people. With 40,000 new users of this drug every year in Taiwan alone, PharmiGene’s kit will surely reduce this risk for a large number of patients. It is estimated the market to be worth around $17 million per year.