China's first ctDNA test kit reviewed with the standard of diagnostic reagents was approved

Source: Yaodu January 20, 2018 On January 19, 2018, China food and Drug Administration (CFDA) approved edbio's super arms ® EGFR gene mutation detection kit through a special approval channel for innovative medical devices, which was used to detect the mutation status of EGFR gene in blood ctDNA of patients with advanced non-small cell lung cancer (NSCLC) in clinical practice, and select patients who are suitable for the treatment of first to third generation EGFR targeted drugs This is the first ctDNA detection kit approved for marketing with the standard of diagnostic reagents, which will open a new mileage of tumor liquid biopsy! Concomitant diagnosis is the premise to achieve accurate treatment of tumor Concomitant diagnostic reagents used to guide the clinical application of drugs must be verified by clinical trials of drug efficacy The super arms ® EGFR gene mutation detection kit has been proved to be able to guide EGFR targeted drug therapy through clinical trials It is the first high-quality and strict quality accompanied diagnostic product reviewed by CFDA with reference to the standard of FDA accompanied diagnostic reagents Super arms technology is a new generation of ctDNA gene mutation detection technology independently patented by Eide biology It is a revolutionary upgrade of ADX arms technology It continues the advantages of simple, fast, accurate, easy to use and so on Its sensitivity is as high as 0.2% It has been included in the consensus of liquid biopsy clinical experts In NSCLC, the proportion of EGFR gene mutations is 40-50%, which is an important target of EGFR targeted drug therapy At present, the first generation of EGFR targeted drugs have been widely included in China's medical insurance for the treatment of EGFR gene mutation positive patients, but tissue sampling of advanced cancer patients is not easy, nearly half of patients missed the opportunity of first-line accurate treatment because they failed to obtain timely detection, Super arms ® EGFR gene mutation detection suitable for blood samples can realize non-invasive sampling and rapid detection, so that more patients can quickly get the opportunity of accurate treatment At the same time, most of the patients will have T790M drug resistance mutation after the first generation of EGFR targeted drug treatment These patients can benefit from the treatment of the third generation of EGFR targeted drug oxitinib, but it is difficult for the patients with relapse of drug resistance to carry out tissue biopsy again, so gene detection based on blood samples is particularly important Professor Zhou caicun of Shanghai Pulmonary Hospital and Professor Wu Yilong of Guangdong People ' V2.0 (Roche) and digital PCR are the highest technology of orr in the evaluation methods It is proved that super arms ® technology is the best choice for clinical ctDNA detection and can effectively guide the treatment of oxitinib With the approval of edbio super arms ® EGFR gene mutation detection kit, more NSCLC patients will have the opportunity to receive high-quality, strict quality control non-invasive gene detection, and accurately guide EGFR targeted drug treatment.