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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.

The Scan

For STEM Students to Stay

New policy changes will make it easier for international STEM students to stay in the US after graduation, the Wall Street Journal reports.

To Inform or Not, To Know or Not

The New York Times writes that some genetic biobanks may re-contact donors if they spot something troublesome, but it notes that not all donors want that information.

Rapid Test Studies

Researchers are examining why rapid tests may be less effective at detecting the Omicron variant and how to improve them, NPR says.

PLOS Papers on SARS-CoV-2 Diversity in Delaware, Metastatic Breast Cancer, Adiposity GWAS

In PLOS this week: genomic analysis of SARS-CoV-2 isolates from Delaware, gene expression and protein-protein interaction patterns in metastatic breast cancer, and more.