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FDA Grants Emergency Use Authorizations for POC COVID Tests from Tangen Biosciences, SD Biosensor

NEW YORK — The US Food and Drug Administration last week separately granted Emergency Use Authorizations for point-of-care SARS-CoV-2 tests developed by Tangen Biosciences and SD Biosensor.

The TangenDx SARS-CoV-2 Molecular Test is designed to detect SARS-CoV-2 nucleic acid in nasopharyngeal, mid-turbinate, and anterior nasal swab specimens from individuals suspected of having COVID-19. It runs on the company's GeneSpark nucleic acid amplification systems.

SD Biosensor's Standard Q COVID-19 Ag Test 2.0 is a lateral flow immunoassay designed to detect nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens collected from symptomatic individuals within the first six days of symptom onset when tested at least twice over three days with at least 48 hours between tests. It is also authorized for use in asymptomatic people when tested at least three times over five days with at least 48 hours between tests.

Both assays are authorized for use by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests, according to the FDA. They are also authorized for use in point-of-care settings operating under a CLIA certificate of waiver, certificate of compliance, or certificate of accreditation.

In early 2020, Branford, Connecticut-based Tangen received $696,000 from the Biomedical Advanced Research and Development Authority to develop a point-of-care SARS-CoV-2 molecular diagnostic for its GeneSpark system.

In May, the FDA issued a consumer warning over concerns of bacterial contamination in SD Biosensor's Pilot COVID-19 At-Home Tests. The South Korean company initiated a recall of the affected tests.