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Kyowa CDx Tests Approved by Regulators in Japan

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.

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