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Tamoxifen has been successfully used for treating breast cancer and preventing cancer recurrence. Cytochrome P450 2D6 (CYP2D6) plays a key role in the process of metabolizing tamoxifen to its active moiety, endoxifen. Patients with variants of the  CYP2D6  gene may not receive the full benefit of tamoxifen treatment. The  CYP2D6*10  variant (the most common variant in Asians) was analyzed to optimize the prescription of tamoxifen in China. To ensure referring clinicians have accurate information for genotype-guided tamoxifen treatment, the Chinese National Center for Clinical Laboratories (NCCL) organized a national proficiency testing (PT) to evaluate the performance of laboratories providing  CYP2D6*10  genotyping. Ten genomic DNA samples with  CYP2D6  wild-type or  CYP2D6*10  variants were validated by PCR-sequencing and sent to 28 participant laboratories. The genotyping results and pharmacogenomic test reports were submitted and evaluated by NCCL experts. Additional information regarding the number of samples tested, the accreditation/certification status, and detecting technology was also requested. Thirty-one data sets were received, with a corresponding analytical sensitivity of 98.2% (548/558 challenges; 95% confidence interval: 96.7–99.1%) and an analytic specificity of 96.5% (675/682; 95% confidence interval: 97.9–99.5%). Overall, 25/28 participants correctly identified  CYP2D6*10  status in 10 samples; however, two laboratories made serious genotyping errors. Most of the essential information was included in the 20 submitted  CYP2D6*10  test reports. The majority of Chinese laboratories are reliable for detecting the  CYP2D6*10  variant; however, several issues revealed in this study underline the importance of PT schemes in continued external assessment and provision of guidelines.

National Prociency Testing Result of CYP2D6*10 Genotyping for Adjuvant Tamoxifen Therapy in China