The Enzo and Access Bio tests may be performed by any CLIA-certified high complexity lab, while use of Gene By Gene's test is limited to its developer.
The firm said its coronavirus assay targets the nucleocapsid and envelope virus genes and is compatible with most RNA extraction methods and qPCR instruments.
The agency said it recommends that clinical laboratory staff and healthcare providers consider any positive result presumptive from the BD SARS-CoV-2 test.
The real-time RT-PCR multiplex test is intended for the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus.
The firm said that its RAQ SARS-CoV-2 PCR Kit allows the replacement of full nucleic acid extraction with a simple heat treatment, decreasing sample processing time.
The two PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in respiratory samples including nasopharyngeal swabs and bronchoalveolar lavage specimens.
The tests are designed to detect regions in the SARS-CoV-2 genome in respiratory samples or antibodies against the virus in human serum, plasma, or blood.
The accelerated approval is based on results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.
The Wall Street Journal reports that Russia's announcement of a coronavirus vaccine approval was met with concern as safety testing has not yet been completed.
Nature News reports that recent proposed changes to the US National Science Foundation have raised concerns about a shift away from the agency's focus on basic research.
