SML Genetree began its first export of molecular diagnostic products to a U.S. CLIA laboratory in May 2026.
This export marks a significant milestone in SML Genetreeโs efforts to enter the U.S. molecular diagnostics market, particularly the laboratory developed test (LDT) market. Following its participation in ADLM 2025 in the United States last year, the company introduced its broad portfolio of molecular diagnostic products to CLIA-certified laboratories and explored potential collaborations with U.S. partners. The latest export demonstrates that these global marketing activities and local network-building efforts have led to tangible business results.
SML Genetree has developed and commercialized a wide range of molecular diagnostic assays for infectious diseases, including sexually transmitted infections, urinary tract infections, respiratory infections, and gastrointestinal infections. The products exported to the United States are assays related to sexually transmitted infections and urinary tract infections, developed specifically for the U.S. market.
CLIA laboratories in the United States are clinical laboratories that must comply with CLIA standards in order to perform diagnostic testing using human specimens. As the United States represents a key market with strong demand for molecular diagnostic testing, including LDTs, SML Genetree plans to use this first export as an opportunity to establish a reference base in the U.S. and strengthen the foundation for further market expansion.
In particular, the company conducted product performance evaluations at a local CLIA laboratory with the aim of entering the U.S. LDT market. Through these evaluations, SML Genetree confirmed both the performance of its products and their applicability in the local clinical testing environment. Based on its proprietary NamuPlexโข brand, the company continues to expand its multiplex molecular diagnostics portfolio while strengthening its product competitiveness and certification capabilities for global market entry.
The latest U.S. export highlights the expansion of SML Genetreeโs global market strategy beyond Japan, Europe, and Latin America into the United States. Starting with its collaboration with a U.S. CLIA laboratory, the company plans to broaden local partnerships, enhance its product portfolio and technical support system, and gradually expand its molecular diagnostics business in the U.S. market.
โThis export to a U.S. CLIA laboratory is a meaningful achievement that once again demonstrates the global recognition of our molecular diagnostic technology and product competitiveness,โ said Lee Dong-soo, CEO of SML Genetree. โAs the United States is one of the most important strategic markets in molecular diagnostics, including LDTs, we will use this milestone to strengthen trust with local customers and partners and advance as a global diagnostic solutions company.โ
Meanwhile, SML Genetree was recently selected as a promising company under the โ2026 Global Small Giant 1000+ Projectโ organized by the Ministry of SMEs and Startups, recognizing its export growth potential. Leveraging policy support and its global network, the company plans to continue expanding overseas certifications, local partnerships, and R&D investment to further solidify its position in the global molecular diagnostics market.
Source: NewsWire | 2026.06.01
https://www.newswire.co.kr/newsRead.php?no=1035495
SML Genetree began its first export of molecular diagnostic products to a U.S. CLIA laboratory in May 2026.
This export marks a significant milestone in SML Genetreeโs efforts to enter the U.S. molecular diagnostics market, particularly the laboratory developed test (LDT) market. Following its participation in ADLM 2025 in the United States last year, the company introduced its broad portfolio of molecular diagnostic products to CLIA-certified laboratories and explored potential collaborations with U.S. partners. The latest export demonstrates that these global marketing activities and local network-building efforts have led to tangible business results.
SML Genetree has developed and commercialized a wide range of molecular diagnostic assays for infectious diseases, including sexually transmitted infections, urinary tract infections, respiratory infections, and gastrointestinal infections. The products exported to the United States are assays related to sexually transmitted infections and urinary tract infections, developed specifically for the U.S. market.
CLIA laboratories in the United States are clinical laboratories that must comply with CLIA standards in order to perform diagnostic testing using human specimens. As the United States represents a key market with strong demand for molecular diagnostic testing, including LDTs, SML Genetree plans to use this first export as an opportunity to establish a reference base in the U.S. and strengthen the foundation for further market expansion.
In particular, the company conducted product performance evaluations at a local CLIA laboratory with the aim of entering the U.S. LDT market. Through these evaluations, SML Genetree confirmed both the performance of its products and their applicability in the local clinical testing environment. Based on its proprietary NamuPlexโข brand, the company continues to expand its multiplex molecular diagnostics portfolio while strengthening its product competitiveness and certification capabilities for global market entry.
The latest U.S. export highlights the expansion of SML Genetreeโs global market strategy beyond Japan, Europe, and Latin America into the United States. Starting with its collaboration with a U.S. CLIA laboratory, the company plans to broaden local partnerships, enhance its product portfolio and technical support system, and gradually expand its molecular diagnostics business in the U.S. market.
โThis export to a U.S. CLIA laboratory is a meaningful achievement that once again demonstrates the global recognition of our molecular diagnostic technology and product competitiveness,โ said Lee Dong-soo, CEO of SML Genetree. โAs the United States is one of the most important strategic markets in molecular diagnostics, including LDTs, we will use this milestone to strengthen trust with local customers and partners and advance as a global diagnostic solutions company.โ
Meanwhile, SML Genetree was recently selected as a promising company under the โ2026 Global Small Giant 1000+ Projectโ organized by the Ministry of SMEs and Startups, recognizing its export growth potential. Leveraging policy support and its global network, the company plans to continue expanding overseas certifications, local partnerships, and R&D investment to further solidify its position in the global molecular diagnostics market.
Source: NewsWire | 2026.06.01
https://www.newswire.co.kr/newsRead.php?no=1035495