Shuwen Biotech, a leading provider of innovative diagnostic products and medical diagnostic services, announced that studies based on its proprietary high-sensitivity CODAR-ARMS PCR liquid biopsy technology was selected to be published at the annual ASCO 2018. Shuwen’s CODAR-ARMS PCR technology demonstrates superior performance and is being showcased at an international conference for the first time.

The CODAR-ARMS PCR mutation detection technology developed by Shuwen has undergone technological innovations to on one hand, preserve the features of ARMS PCR technology which is recognized to be simple, rapid, and specific, and on the other hand has greatly improved the detection sensitivity of the liquid biopsy assay. The CODAR-ARMS PCR technology simultaneously detects mutations in DNA/RNA from whole blood and further combines efficient sample extraction techniques with optimally modified primers to greatly improve the discrimination between mutant and wild-type gene sequences. The ability to detect mutations at the 0.01% level in a wild-type background can be achieved using an ordinary high-throughput fluorescence quantitative PCR platform.

The study being presented at ASCO took the EGFR T790M mutation as an example, using the CODAR-ARMS PCR technique to detect the EGFR T790M mutation in the blood of drug-resistant lung cancer patients treated with first generation EGFR inhibitors.  EGFR T790M mutation-positive patients were then treated with Osimertinib. In this prospective study, the CODAR-ARMS PCR technique was superior to ddPCR in predicting the efficacy of Osimertinib. This study demonstrated that Shuwen’s CODAR-ARMS PCR technology is more sensitive, more cost-efficient, and has a higher throughput than digital PCR, and most importantly has higher prediction power on drug efficacy. Its applications span companion diagnostics (CDx) for new drug development and for currently available T790M inhibitors.