Monday, May 7, 2012

Kyowa Medex Launched POTELIGEO® TEST IHC and POTELIGEO® TEST FCM,Companion Diagnostics of POTELIGEO® Injection in Japan

Kyowa Medex Co., Ltd. announced today that it has launched two in vitro diagnostic ("IVD") reagents, POTELIGEO® TEST IHC and POTELIGEO® TEST FCM ("POTELIGEO® TEST").   POTELIGEO® TEST is designed to help physicians to identify appropriate subpopulations of adult T-cell leukemia-lymphoma (ATL) patients who are most likely to respond to POTELIGEO® (Mogamulizumab) Injection ("POTELIGEO®"). POTELIGEO® is a therapeutic antibody for which Kyowa Hakko Kirin has a new drug application (NDA) approved from the Ministry of Health, Labour and Welfare on March 30. The combination of IVD and treatment has potential to contribute a personalized medicine by providing better treatment options with appropriate patients.
POTELIGEO® binds to CCR4 that is expressed on the surface of ATL cells. ATL cells are killed by ADCC activity. POTELIGEO® TEST can examine the presence of CCR4 expressed by ATL cells before treatment of POTELIGEO®. Diagnostic reagent having principle of immunohistochemistry (IHC) is used to tissue samples such as lymph nodes or skins of ATL patients. Diagnostic reagent based on flow cytometry (FCM) can be applied to blood samples of ATL patients.