LabGenomics Nears Securing 4 US CLIA Labs, the First and Only in Korea... Signal for NGS Entry into the US Market

(From left) Park Eungjo, Senior Manager at Labgenomics Headquarters; Israel Villasenor, CEO of IMD; Cho Junghui, CEO of Labgenomics USA; Tim Rich, CBO of QDx; Tim Deater, Western Regional Sales Manager of QDx; Scott Ossi, BD Manager of IMD; Kim Aram, Manager at Labgenomics Headquarters; Louis Tzoumbas, COO of IMD; Mary Beth Essa, Sales Manager of IMD; Ashley Rahbarpour, Sales Manager of QDx California. / Photo by Labgenomics

Genome molecular diagnostics specialist LabGenomics announced on the 30th that it has completed the due diligence for the IMD deal in the United States and plans to finalize the acquisition within two weeks. Once the acquisition is completed, LabGenomics will become the first and only company in Korea to own four CLIA labs in the U.S., enabling coverage across the entire country.

Building on the existing QDx lab in the East, LabGenomics will leverage the newly acquired Central and West CLIA labs to provide next-generation sequencing (NGS) services in the U.S. The blood cancer and solid tumor NGS services offered by IMD’s Aurora lab hold 'CPT codes' and 'Z codes' that are reimbursable by insurance, allowing for rapid expansion of coverage.

IMD is also jointly developing a comprehensive cancer panel with the renowned U.S. general hospital, Cedars-Sinai Medical Center. After successfully completing analytical performance testing, clinical performance testing is being finalized, with plans to officially launch it as a laboratory-developed test (LDT). LabGenomics aims to build a diverse cancer testing portfolio by leveraging its track record as the first in Korea to commercialize NGS-based prenatal malformation screening services.

Kim Jung-joo, CEO of LabGenomics, stated, "Combining the sales capabilities and insurance networks of the four CLIA labs with LabGenomics’ technological expertise is expected to create tremendous synergy." He added, "We will also enhance competitiveness by collaborating with Dr. Petros Giannikopoulos, one of the leading cancer diagnostics authorities at IMD."

Notably, IMD has a contract with Blue Cross Blue Shield, the top-grossing insurance company in the U.S., which is expected to positively impact QDx’s revenue growth. While QDx specializes in pathology testing, IMD primarily serves long-term care hospitals and cancer specialty hospitals, allowing for complementary profitability.

CEO Kim said, "With a pioneering spirit that no one has attempted before, we are pioneering the U.S. local market as a Korean diagnostic company," and added, "We will successfully establish a system for the U.S. entry of various K-diagnostic technologies."

He continued, "We will implement a strategy to dominate the largest diagnostic market, the U.S., by introducing LDT services that enable both revenue growth and cost reduction," emphasizing, "Following the first LDT shipped in August, we plan to supply more than 10 product lines locally in the U.S."

Meanwhile, LabGenomics announced on the 19th that it will acquire IMD, which operates CLIA labs in Berkeley, Sacramento, and Aurora in the U.S. Previously, it acquired QDx in the East last year and completed the development of its first LDT, RPP Essential, in August, commencing full-scale shipments.