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BillionToOne, Sugentech Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for BillionToOne's Sanger sequencing-based SARS-CoV-2 test, as well as an antibody test for the virus developed by South Korean diagnostics firm Sugentech.

BillionToOne's qSanger-COVID-19 test is designed to detect viral nucleic acid in upper respiratory specimens and requires no RNA extraction. As described in a manuscript released by the Menlo Park, California-based company in April, the test involves sequencing a single amplicon from the viral genome along with an RNA spike-in control, followed by data analysis with proprietary software.

The test may be performed by any lab certified to perform high-complexity tests. BillionToOne said that it began international distribution of the test in May and that it has been adopted by Brazilian medical diagnostics lab DASA.

Sugentech's SGTi-flex COVID-19 IgG is designed to detect immunoglobulin G antibodies against SARS-CoV-2 in serum, plasma, and venous whole blood. Results are provided within 10 minutes.

The test may be performed by any lab certified to perform moderate- or high-complexity tests.