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.
Gencurix's test is capable of detecting 46 mutations in the EGFR gene associated with response to therapies that inhibit tyrosine kinase. The panel includes the T790M mutation and C797S mutations, associated with second- and third-generation drug responses, respectively.
To meet Korean MFDS guidelines for clearance, the company carried out a clinical trial in NSCLC patients, identifying patients who responded to Tarveca, a TKI marketed in Korea by Roche. Gencurix said it gained clearance on the basis of this validation.
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.