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FDA Grants Emergency Use Authorizations for Gencurix, Laihe Biotech Coronavirus Tests

NEW YORK — The US Food and Drug Administration has granted separate Emergency Use Authorizations for SARS-CoV-2 tests developed by Gencurix and Laihe Biotech.

Gencurix' GenePro SARS-CoV-2 Test is designed to detect the virus' Orf1-ab and RdRP genes in nasopharyngeal swab samples. It runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio Dx RT-PCR instrument or Bio-Rad's CFX96 RT-PCR system, and can be used with 384-well plates, according to the company. Based in Seoul, South Korea, Gencurix develops molecular diagnostics.

The FDA issued an EUA to Laihe's Lyher Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit on June 19. The test is an immunochromatography-based lateral flow assay designed to detect immunoglobulin M and G antibodies against SARS-CoV-2 in human serum and plasma. Laihe is a life science firm based in Zhejiang, China that develops point-of-care tests and other diagnostic technologies.