Lianxing Yang, Ph.D. and Darryl Irwin*, Ph.D., Agena Bioscience
*Corresponding author: Darryl.Irwin@AgenaBio.com
Overview
Many laboratories in China are running KRAS mutation detection assays to guide therapy selection for cancer treatment. To promote clinical KRAS mutation detection and improve the quality of laboratory testing, the National Center for Clinical Laboratories (NCCL) of the China Ministry of Health launched a KRAS External Quality Assessment project in 2014. In preparation for the project, the NCCL conducted a preliminary National KRAS Mutation Detection Inter-Lab Quality Evaluation Survey in 2013.
This preliminary study encompassed over 50 laboratories, including five labs which utilize the MassARRAY® System from Agena Bioscience. All five labs using the MassARRAY System produced highly concordant results, and were awarded a certificate by the Ministry of Health for passing the study criteria. The MassARRAY System was the only technology in the study that covered all KRAS mutations and had all its sites pass the study criteria. In addition, Agena Bioscience’s iPLEX® Pro Sample ID Panel was able to demonstrate that the single discrepant MassARRAY result was not a false negative, but in fact due to sample mix-up.