페이지 정보작성자 Gencurix 댓글 0 1,842 작성일 17-09-29 09:45
NEW YORK (GenomeWeb) –The Korean Ministry of Food and Drug Safety has cleared Gencurix's GenesWell ddEGFR Mutation Test for clinical use as a companion diagnostic, the company said this week.
Gencurix's assay can be used to select which non-small cell lung cancer patients will respond to tyrosine kinase inhibitors. The test is run on Bio-Rad's droplet digital PCR-based platform.
CEO Sang Rae Cho said in a statement that the clearance is in line with the Seoul-based company's strategy to deliver companion diagnostics to the clinical market. "We are ... trying to provide more accurate, targeted therapy by researching and developing [companion diagnostics] in various cancer fields," he said.
The company is now preparing to seek a CE-IVD mark for the assay. It also is planning a clinical trial in the US ahead of a planned 2018 submission to the US Food and Drug Administration. It also said it intends to make the test available in the Chinese and Japanese markets.
Gencurix is separately planning to file its GenesWell BCT breast cancer prognostic with the agency for 510(k) clearance next year. The real-time PCR-based assay measures RNA biomarkers to predict patient survival rates in relation to chemotherapy.