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FDA Grants Emergency Use Authorization for Genetworx Molecular COVID-19 Tests

NEW YORK — The US Food and Drug Administration has recently granted Emergency Use Authorizations for two PCR-based COVID-19 tests developed by Genetworx.

Both assays — the Gx HTKB SARS-CoV-2 Test and the Gx HTIQ SARS-CoV-2 Test — are designed to detect SARS-CoV-2 nucleic acid in mid-turbinate and anterior nasal swab specimens from individuals with or without symptoms using Wuxi Nest Biotechnology's Nest collection device.

Testing of collected patient samples is limited to Glen Allen, Virginia-based Genetworx's CLIA-certified facility, according to the FDA.

In late 2020, Genetworx received EUA from the FDA for a COVID-19 test that uses self-collected nasal swab specimens. Less than a year later, the company paid $1.4 million to settle a false claim lawsuit tied to allegations of billing Medicare for invalid genetic tests.