LabGenomics Completes Registration of Second 'LDT GPP' with FDA-Level Approval Standards

Global genomics company LabGenomics announced on July 15 that it has completed the development of its second Laboratory Developed Test (LDT), GPP (Gastrointestinal Pathogen Panel), and has registered the product in New Jersey State through QDx. This marks the company's second achievement following the registration of its first LDT, RPP Essential. As GPP is a core test that accounts for 30% of QDx's total sales, the company expects the improvement in profitability to be reflected immediately.

Additionally, successfully completing the LDT registration process in New Jersey, which is known for its strict standards comparable to FDA approval, is considered to have symbolic significance. It demonstrates not only the company's entry into the US market but also that Korea's molecular diagnostic technology and clinical reliability have met local US standards.

LabGenomics partnered with domestic molecular diagnostics specialist Atoplex to successfully develop GPP, and the product drew attention by completing clinical validation at QDx and achieving registration. In particular, the successful development, clinical validation, and registration of GPP has proven the feasibility of the 'K-Diagnostics Platform' vision proposed by Luha Private Equity, LabGenomics' largest shareholder, by creating synergy between Korea's molecular diagnostic technology and the US diagnostic service market.

A company representative stated, "It took longer than initially expected to register GPP due to various factors such as clinical validation and registration procedures, but we are currently performing over 60,000 GPP tests annually and expect to achieve approximately 50% cost reduction compared to existing products. Moving forward, we plan to actively utilize our CLIA labs QDx and IMD in the US as clinical test beds and continue to launch various high value-added LDT panel lineups, including for STI (sexually transmitted infections) and women's diseases."

According to global market research firm PBI, the US gastrointestinal molecular diagnostics market is expected to grow at an average annual rate of 3.6% from approximately $150 million in 2023. In addition, due to the increasing prevalence of gastrointestinal infectious diseases, improvements in molecular diagnostic accuracy, and continued growth in demand, the GPP diagnostics market is seen as having high growth potential. As a result, other CLIA labs in the US are also expected to show interest in the LDT-based GPP diagnostic technology introduced through this Korea-US collaboration.

A LabGenomics representative stated, "The newly introduced LDT GPP test can be performed on samples collected from most states in the US, and as the test volume is high, we expect to accumulate test data rapidly. In the long term, once we secure a certain level of test data, we plan to apply for US FDA IVD (in vitro diagnostic) approval and establish a structure that allows us to sell in the global diagnostics market."