Labgenomics announced on the 14th that it has completed the development of its first in-house Laboratory Developed Test (LDT), RPP Essential, and is beginning full-scale shipments. As the first domestic diagnostic company to sell an LDT, Labgenomics is expected to gain momentum in entering the global diagnostic market.
LDT products can provide diagnostic services without approval from the U.S. Food and Drug Administration (FDA). RPP Essential can diagnose various respiratory diseases such as Influenza A and B, COVID-19, the Omicron variant, and Respiratory Syncytial Virus (RSV) through a single real-time reverse transcription polymerase chain reaction (RT-PCR). It detects viruses more precisely than existing products and achieves cost reduction of up to 90% through in-house development.
A Labgenomics official stated, "The strategy of 'K-diagnostic platform through the acquisition of Clearlab' by Luha Private Equity, which acquired management rights, is progressing successfully," adding, "With the introduction of LDT, we have achieved cost reduction for high-quality diagnostic products, enabling both maximization of profitability and securing new growth engines."
They continued, "As respiratory infection management is gaining importance worldwide, including in the U.S., the market is steadily expanding," and added, "We expect sales growth through the local sales network of Clearlab QDx, which was acquired last year."
Labgenomics also plans to introduce RPP Extended, which detects adenovirus, Bordetella pertussis, and others. The company will sequentially develop products and supply them to various Clearlabs, including QDx. As demand for multiplex tests that simultaneously diagnose various respiratory diseases such as influenza and COVID-19 continues to increase, the sales effect of RPP Essential is expected to appear rapidly.
A company representative explained, "We will expand our role as a bridgehead for domestic diagnostic companies entering the U.S. market," and added, "Based on the know-how gained from introducing LDT to QDx, we will promote its introduction to other Clearlabs and accelerate external growth."
Since the acquisition of QDx, Labgenomics' overseas sales proportion has been increasing. Overseas sales in the first quarter recorded 12 billion KRW, about 100 times growth compared to the same period last year. With the introduction of various LDTs such as RPP Extended, GPP (gastrointestinal pathogen panel), and STI (sexually transmitted infection) starting in the second half of this year, the proportion of overseas sales is expected to expand further.
There are approximately 380,000 Clearlab companies in the U.S., forming a market worth about 70 trillion KRW. Labgenomics aims to stand shoulder to shoulder with industry leaders such as Labcorp and Quest in the Clearlab market.
Labgenomics also held a shipment ceremony for RPP Essential.
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
