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KMID : 1101420170490020079
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Korean Journal of Clinical Laboratory Science
2017 Volume.49 No. 2 p.79 ~ p.87
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An Analytical Validation of the GenesWellTM BCT Multigene Prognostic Test in Patients with Early Breast Cancer
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Kim Jee-Eun
Kang Byeong-Il
Bae Seung-Min
Han Sae-Bom
Jun A-Reum
Han Jin-Il
Cho Min-Ah
Choi Yoon-La
lee Jong-Heun
Moon Young-Ho
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Abstract
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GenesWellTM BCT is a 12-gene test suggesting the prognostic risk score (BCT Score) for distant metastasis within the first 10 years in early breast cancer patients with hormone receptor-positive, HER2-negative, and pN0∼1 tumors. In this study, we validated the analytical performance of GenesWellTM BCT. Gene expression values were measured by a one-step, real-time qPCR, using RNA extracted from FFPE specimens of early breast cancer patients. Limit of Blank, Limit of Detection, and dynamic range for each of the 12 genes were assessed by serially diluted RNA pools. The analytical precision and specificity were evaluated by three different RNA samples representing low risk group, high risk group, and near-cutoff group in accordance with their BCT Scores. GenesWellTM BCT could detect gene expression of each of the 12 genes from less than 1 ng/μL of RNA. Repeatability and reproducibility across multiple testing sites resulted in 100% and 98.3% consistencies of risk classification, respectively. Moreover, it was confirmed that the potential interference substances does not affect the risk classification of the test. The findings demonstrate that GenesWellTM BCT have high analytical performance with over 95% consistency for risk classification.
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KEYWORD
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GenesWellTM BCT, Analytical validation, BCT score, Early breast cancer, Gene expression
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