SomaGen, COVID-19 Diagnostic LDT Service Receives US FDA Emergency Use Authorization

[Asia Economy Reporter Hyunseok Yoo] SomaGen, a U.S. bio company preparing for a listing on the KOSDAQ market on the 13th, announced on the 1st that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its COVID-19 diagnostic LDT (Laboratory Developed Test) service.

This approval is the first for a Korean-American company. The LDT service refers to diagnostic testing services developed independently by laboratories certified under CLIA Lab. SomaGen has completed the development of the COVID-19 virus diagnostic LDT service called ‘Psoma COVID-19 RT Test’ at its own CLIA Lab. The company applied for EUA from the U.S. FDA on April 21.

SomaGen plans to provide the approved ‘Psoma COVID-19 RT Test’ starting as early as this month, focusing on large hospitals in the Washington DC area, including Johns Hopkins Hospital. A company official emphasized, “The estimated profit and loss presented during the valuation for the KOSDAQ market public offering did not reflect any sales from the newly approved COVID-19 diagnostic LDT service, and we are also considering additional sales from COVID-19 diagnostic services through facility expansion in the second half of this year.”

CEO Ryan Kim stated, “This EUA approval from the U.S. FDA officially verifies SomaGen’s RT-PCR (real-time gene amplification test) analysis capability,” adding, “Through this, we aim to enhance the SomaGen brand recognition in the U.S. genome analysis and diagnostic market, and plan to build and expand a disease diagnostic platform that enables rapid development and provision of diagnostic services for infectious diseases that may occur worldwide in the future.”

This content was produced with the assistance of AI translation services.