NGeneBio said on Monday that it established a fully owned U.S. subsidiary called NGeneBioAI which will operate as an AI precision diagnosis software company.

The subsidiary is expected to serve as a bridgehead for NGeneBio to tap into the U.S. cancer diagnosis market valued at approximately $4.1 billion.

By utilizing its next-generation sequencing (NGS) precision diagnosis platform in the U.S. market, NGeneBio plans to launch cancer data analysis services, develop AI-based precision diagnosis software and build a Clinical Laboratory Improvement Amendments (CLIA) precision diagnosis platform.

The company also plans to apply cancer genomic data to commercialize data-based early cancer diagnosis technology by improving diagnostic accuracy and strengthening predictive power. The supply of NGeneBio's NGS precision diagnosis products will also begin in earnest through partnerships with CLIA Labs in the U.S.

Last December, NGeneBio and LabGenomics signed a memorandum of understanding to cooperate in next-generation sequencing (NGS) services by taking advantage of the CLIA Lab in the U.S., which LabGenomics plans to acquire.

As the demand for precision diagnostics such as NGS increases in the U.S. market, the need for bioinformatics software that can accurately analyze complex biological data is increasing. Consequently, NGeneBio plans to target the U.S. data-based cancer genomic diagnosis market through precision diagnosis software, NGeneAnalySys. 

"NGeneAnalySys is being used for cancer precision diagnosis analysis not only in Korea but also in overseas medical institutions such as Europe and the Middle East," said a company official from NGeneBio. "We are now discussing cooperation with CLIA in the U.S. based on the performance of NGeneAnalySys and will accelerate our ongoing strategic investment in CLIA labs to finalize it within the year."

The precision diagnostic software technology is being used in clinical trials for cancer patients at medical institutions at home and abroad and has been well-recognized by clinicians.