NGeneBio gets approval for cancer diagnostic device in Thailand

South Korean medical diagnostic company NGeneBio Co. announced on Friday that it has received approval for the sale of its in-vitro diagnostic medical device, "SOLIDaccuTest DNA," based on next-generation sequencing (NGS) technology from the Thailand Food and Drug Administration.

The product is composed of NGS precision diagnostic reagents that extract 84 cancer-related genes highly associated with lung, colorectal, stomach and breast cancers, among others, from cancer tissues.

It also includes software that analyzes and interprets cancer genetic mutations, recommending optimal anticancer therapies for patients.

NGeneBio previously obtained approval for its precision diagnostic products, "BRCAaccuTest PLUS" for breast cancer in Thailand in May last year, and "HEMEaccuTest" for blood cancer last month. The products were supplied to the testing facility of the Thai molecular diagnostics company MP Group.

"With the approval of our solid cancer diagnostic product as a Class 3 (high-risk) medical device in Thailand, we have strengthened our credibility in Thailand, which is the largest medical market in the ASEAN region," said NGeneBio CEO Choi Dae-Chul. "We will enhance localization strategies tailored to each country's healthcare system, accelerating global growth."

According to NGeneBio, the Thai medical device market is expected to grow at an annual rate of 6.1% from 2019, reaching a size of $3.4 billion by 2027.

Write to Yena Kim at yena@hankyung.com