NEW YORK (GenomeWeb News) – Japanese reagent and medical device firm Kyowa Medex today announced regulators in Japan have approved two companion diagnostics for a drug targeting adult T-cell leukemia-lymphoma (ATL).
The Ministry of Health, Labour, and Welfare approved Kyowa's Poteligeo Test IHC and Poteligeo Test FCM for Kyowa Hakko Kirin's Poteligeo (mogamulizumab) injection, a therapeutic antibody that was also approved by MHLW today.
Kyowa Medex is a wholly owned subsidiary of Kyowa Hakko Kirin.
Poteligeo binds to CCR4, which is expressed on the surface of ATL cells. ATL cells are killed by antibody-dependent cell-mediated cytotoxicity activity. The two companion diagnostic tests approved today detect for the presence of CCR4 expressed by ATL cells before treatment with Poteligeo. As a result, physicians can identify patients who would most benefit from the drug, Kyowa said.
Poteligeo Test IHC is immunhistochemistry-based and is for use on tissue samples, such as lymph nodes. Poteligeo Test FCM uses flow cytometry to analyze blood samples from patients.