Gencurix said Tuesday that its lung cancer companion diagnostic test has received marketing authorization from the Thai Food and Drug Administration. The approval was granted for Droplex EGFR Mutation Test v2, a liquid biopsy lung cancer companion diagnostic test.

Companion diagnostic test is an essential diagnostic method for the safe and effective use of drugs. The technology can improve treatment effectiveness by linking drug treatment and diagnostic tests to expand the use of drugs.

Droplex EGFR Mutation Test v2 is a companion diagnostic test used to select the most appropriate targeted therapy for individual patients in lung cancer treatment. In Korea, it is licensed as an in vitro diagnostic medical device to help screen non-small cell lung cancer (NSCLC) patients for prescribing the targeted therapies Tarseva (erlotinib) and Tagrisso (osimertinib).

Droplex EGFR Mutation Test v2 is an upgrade of the existing V1 product with significant performance improvements. Unlike existing companion diagnostic products, the new product can accurately detect even “Exon 20 Insertions” mutations that attract attention as new drugs are launched.

According to Gencurix, the company has also won marketing approval for its new product in the United Arab Emirates and Colombia, pushing to export it to the Middle East and Latin American markets.

As the numbers of domestic and international licenses and hospitals using it increases, Gencurix expects the company's companion diagnostics sales to continue to grow.

"There are high interests from Korean and overseas customers in Droplex companion diagnostic products," a company official said, "We will continue to actively pursue sales growth as soon as we finish the approval process at home and abroad."