SomaGen Selected as Provider of "SalivaDirect™" COVID-19 Diagnostic Service

[Asia Economy Reporter Hyunseok Yoo] SomaGen (Reg.S) announced on the 14th that 'SalivaDirect™,' developed by Yale School of Public Health (YSPH) and granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) last August, has been selected as a supplier of COVID-19 diagnostic services. The company plans to provide SalivaDirect™ COVID-19 diagnostic services across the United States.

SalivaDirect™, developed to improve the speed, ease, and cost of COVID-19 testing, meets the licensing requirements according to FDA guidelines and has passed proficiency testing, allowing the service to be provided only at CLIA Labs designated by Yale School of Public Health. This test can rapidly detect SARS-CoV-2 within 2 to 3 hours through a new saliva sample processing method known as RT-qPCR. Unlike other methods, it does not require a separate nucleic acid extraction step, minimizing the risk of kit or reagent shortages while saving time and costs.

Ryan Kim, CEO of SomaGen, emphasized, "The ability to easily and quickly diagnose COVID-19 from various types of specimens is a very important aspect of managing the virus currently," adding, "With the addition of the SalivaDirect™ test to SomaGen’s existing testing capabilities, we have created an opportunity to expand and provide rapid diagnostic services."

By using SalivaDirect™, individuals can collect their own saliva samples directly into sterilized containers under the supervision of healthcare professionals without swabs or other collection tools. Unlike swab tests, this method is non-invasive and painless, and the company expects a significant increase in testing demand.

SomaGen is headquartered in Maryland, USA, with branches in Virginia, New York, and Massachusetts. It is a leading genomic analysis service provider holding CLIA and CAP certifications. The company currently offers comprehensive solutions to a diverse range of clients in academia, pharmaceuticals, biotechnology, and diagnostics industries. Specifically, it provides top-tier services in NGS (Next-Generation Sequencing), Sanger sequencing, clinical sequencing, bioinformatics, direct-to-consumer genomic analysis, and human microbiome fields.

Additionally, SomaGen already offers the ‘Psoma COVID-19 RT Test,’ a COVID-19 diagnostic LDT (Laboratory Developed Test developed in a CLIA-certified lab) service that received EUA from the U.S. FDA in June, within the United States.

A SomaGen representative explained, "It is expected to take considerable time before COVID-19 vaccines are distributed nationwide in the U.S. and their effects become apparent. Considering the anticipated normalization of local public schools and various institutions and businesses after early next year, preemptive and regular demand across all sectors is expected to increase significantly," adding, "We plan to focus on targeting public schools and key related institutions to expand the provision of SalivaDirect™ COVID-19 diagnostic services."

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