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Amazon, NeuMoDx, Becton Dickinson Get FDA Emergency Use Authorizations for Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for three new SARS-CoV-2 assays developed by Amazon, NeuMoDx Molecular, and Becton Dickinson.

The Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 is designed to detect the ORF1ab gene of the virus in anterior nasal swab specimens self-collected using either the Amazon COVID-19 Collection Kit under the supervision of a healthcare provider or the Amazon COVID-19 Test Collection Kit unsupervised at home. The test may be used with either individual samples or up to five pooled samples and runs on Thermo Fisher Scientific's Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument or its QuantStudio 5 system.

Amazon's test, which was developed by subsidiary STS Lab, is a modified version of BGI Genomics' FDA-authorized Real-Time RT-PCR Test for Detection of SARS-CoV-2. Seattle-based Amazon said that it intends to use the test for employees and other individuals who enter its facilities as part of its COVID-19 preparedness and response program. The test may only be used by labs designated by STS Lab that are CLIA-certified to perform high-complexity tests.

The NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Assay is designed to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus in nasopharyngeal or anterior nasal swab specimens. It runs on the NeuMoDx 288 or NeuMoDx 96 molecular systems and may be used by any lab CLIA-certified to perform moderate- or high-complexity tests.

Ann Arbor, Michigan-based NeuMoDx, which was acquired by Qiagen last year, received CE-IVD marking for the test in November.

Becton Dickinson's BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B is designed for the detection and differentiation of SARS-CoV-2 nucleocapsid antigen and influenza A and B nucleoprotein antigens in anterior nasal swabs.

The chromatographic digital immunoassay runs on the BD Veritor System, providing results within 15 minutes. It can be used by labs CLIA-certified to perform moderate-, high-, or waived-complexity tests, as well as in a point-of-care setting.

In mid-2020, Franklin Lakes, New Jersey-based Becton Dickinson received FDA EUA for the BD Veritor Plus SARS-CoV-2 assay.