Abstract
The current first-line therapy of chronic myeloid leukemia (CML) is based on tyrosine kinase inhibitors. Diagnostic kits that are capable of identifying at least a 4.5 log reduction in the international scale % BCR-ABL/ABL (IS % BCR-ABL/ABL) are needed for use in the clinical evaluation of deeper molecular response to treatment and to determine the timing of dose selection or treatment interruption during the course of treatment. In this study, we evaluated the performance of a new diagnostic kit, ODK-1201, designed to be capable of performing reverse transcription and quantitative PCR in a single tube for the quantitation of major BCR-ABL mRNA. The kit demonstrated excellent assay performance (limit of detection 0.0007 %) and a broader detection range of BCR-ABL mRNA in peripheral blood compared to a commercially available kit for CML (Amp-CML). ODK-1201 was also shown to be as sensitive as Ipsogen and Molecular MD kits in the same assay. Results obtained in this study indicate evidences that ODK-1201 was capable of identifying at least a 4.5 log reduction in the IS % BCR-ABL/ABL.
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We would like to thank for all physicians who were involved in the expert care of the patients during the clinical study period.
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These results are summarized from the clinical study of ODK-1201 kit (Sponsored by Otsuka Pharmaceutical Co. Ltd.). H.N. has received research funding and honoraria from Otsuka to report during the conduct of the study. T.N. received grants and personal fees from Otsuka Pharmaceutical Co., Ltd., during the conduct of the study; grants and personal fees from Bristol-Myers Squibb, grants and personal fees from Celgene K.K., grants and personal fees from Chugai Pharmaceutical Co., Ltd., grants and personal fees from Dainippon Sumitomo Pharma Co., Ltd., grants and personal fees from Fujifilm Corporation, grants and personal fees from Kyowa-Hakko Kirin Co., Ltd., grants and personal fees from Nippon Boehringer Ingelheim Co., Ltd., grants and personal fees from Novartis Pharma, grants and personal fees from Otsuka Pharmaceutical Co., Ltd., grants from Zenyaku Kogyo Co., Ltd., outside the submitted work;. Another, relevant to the clinical study, C.Y. received honoraria from Otsuka to report. Y.M., M.H. and N.U. have no COI. K.D. and T.S. are employees of Otsuka. I.M. and Y.K. have provided consultancy and received honoraria from Otsuka.
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Nakamae, H., Yoshida, C., Miyata, Y. et al. A new diagnostic kit, ODK-1201, for the quantitation of low major BCR-ABL mRNA level in chronic myeloid leukemia: correlation of quantitation with major BCR-ABL mRNA kits. Int J Hematol 102, 304–311 (2015). https://doi.org/10.1007/s12185-015-1826-9
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DOI: https://doi.org/10.1007/s12185-015-1826-9