NGeneBio, a Kosdaq-listed precision diagnostics company, said Friday that it has obtained marketing authorization from the Thai Food and Drug Administration (TFDA) for Solidaccutest DNA, a solid cancer precision diagnostic panel based on next generation sequencing (NGS) technology.

Solidaccutest DNA can extract 84 cancer genes highly associated with the development of major solid cancers such as lung, colon, stomach, and breast cancer from cancer tissue, enabling accurate analysis of cancer gene data produced by NGS equipment.

Also, Solidaccutest DNA has been certified as a European In Vitro Diagnostic Device (IVD) and is being used not only in medical institutions in Korea but also in Singapore and Germany in recognition of its safety and reliability.

For entry into the Thai medical market, a company must obtain a medical device license from TFDA, the regulatory authority under the Medical Device Act of 2008.

In May last year, NGeneBio obtained approval from the TFDA for Brcaaccutest Plus, a precision diagnostic panel for breast cancer, and Hemeaccutest, a precision diagnostic panel for blood cancer, in November this year, and is supplying them to MP Group, a molecular diagnostics company in Thailand.

With the latest approval, NGeneBio has secured marketing authorization for all three of its flagship products, further strengthening its presence in the ASEAN region.

"With the approval of our solid cancer diagnostic product in Thailand, the largest medical market in ASEAN, we have strengthened our credibility in the ASEAN region," said NGeneBio CEO Choi Dae-chul. "We will continue to accelerate our global growth by strengthening our localization strategy to suit each country's medical system."

Based on the market research firm Statista's report on the market value of medical devices in Thailand, the scale of the Thai medical device market is projected to reach $3.4 million in 2027, experiencing an annual growth rate of 7 percent from $1.8 million in 2019.