On June 12, the National Center for Clinical Laboratories (NCCL) released its “2018 International ctDNA Gene Mutation Detection External Quality Assurance Survey Results Report”. In the report, Genecast Precision Medical Testing Laboratory (Wuxi), a subsidiary of Genecast Biotechnology Co., Ltd., scored full marks in the High-throughput Sequencing (NGS qualitative) test.

This evaluation of ctDNA gene mutation detection is an international external quality assurance program. A score of 100%, therefore, means that Genecast Medical Laboratory (GML) has been fully recognized by China’s leading authority on standard operational processes and quality control in gene detection—standards that GML has continuously and rigorously maintained. This score also signifies that GML’s NGS laboratories are now at the forefront of ctDNA genetic mutation detection in China, and that it is an industry leader in standardization and accuracy of laboratory procedures.

The evaluation involved a joint effort between the NCCL and the Royal College of Pathologists of Australasia Quality Assurance Programs. It aimed to evaluate the ability of clinical laboratories around the world to detect mutations in ctDNA genes. A total of 116 laboratories in China participated in this EQA, and eight samples, numbered 1801, 1802, 1803, 1804, 1805, 1806, 1807 and 1808, were released for quality assurance and evaluation on all detections of variant types (SNV, CNV and fusion). The percentage of mutant alleles was approximately 0.01%-15%.