Medical and Biological Laboratories of Japan has launched the MEBRIGHT NUDT15 kit for detecting genetic polymorphisms in the NUDT15 (Nudix Hydrolase 15) gene, which can predict serious side effects of thiopurine drugs.
Thiopurine drugs are often prescribed to patients with inflammatory bowel disease, leukemia, rheumatic disease, or after an organ transplant, but clinical studies have shown that the drugs can induce adverse effects such as severe leukopenia and alopecia universalis within about eight weeks. A strong correlation has also been demonstrated between the development of serious adverse effects of thiopurine drugs and polymorphism in NUDT15, particularly among East Asians, Medical and Biological Laboratories said.
Using real-time PCR, the kit detects polymorphisms at codon 139 of NUDT15 in DNA from a patient's blood. The kit requires a processing time of two hours and simultaneously measures multiple samples, the firm said. The kit, which was jointly developed with Tohoku University, was approved as an in vitro diagnostic test by Japan's Pharmaceutical and Medical Device Agency in April.