Korean MFDS Clears Gencurix Lung Cancer Test

NEW YORK (GenomeWeb) – The Korean Ministry of Food and Drug Safety has cleared Gencurix’s GenesWell ddRGFR 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 a 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 resistance 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

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