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FDA Grants Emergency Use Authorization to Coronavirus Tests From Visby Medical, SNIBE

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations for a molecular SARS-CoV-2 test developed by Visby Medical and a SARS-CoV-2 antibody test developed by Shenzhen New Industries Biomedical Engineering (SNIBE).

The Visby Medical COVID-19 Test is a single-use, fully integrated device designed to detect the SARS-CoV-2 nucleocapsid gene in either nasopharyngeal, nasal, or mid-turbinate swabs collected by a healthcare provider or in nasal or mid-turbinate swabs self-collected in a healthcare setting. Samples are placed within the test unit, where nucleic acid extraction and purification, PCR amplification, and target detection occurs. Results are provided within 30 minutes.

San Jose, California-based Visby is also developing its PCR device for a number of other infectious disease applications within sexual health.

SNIBE'S Maglumi 2019-nCoV IgM/IgG test comprises a capture chemiluminescence immunoassay for immunoglobulin M antibodies against SARS-CoV-2 and an indirect chemiluminescence immunoassay for immunoglobulin G antibodies against the virus. It uses human serum and serum in separating gel tube samples and runs on the company's Maglumi 2000 series fully automated chemiluminescence immunoassay analyzer.

Both tests may be used by any lab certified to perform moderate- or high-complexity tests, the FDA said.

In February, SNIBE said it received CE marking for the Maglumi 2019-nCoV IgM/IgG test. Last month, the Shenzhen, China-based firm received CE marking for a fully automated quantitative serology test for detecting IgG antibodies against SARS-CoV-2S-RBD, the receptor-binding domain of the S protein.