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The lateral flow test delivers results in 15 minutes without instrumentation and has a sensitivity of 97 percent and specificity of almost 99 percent.
QDx's RT-PCR-based test is designed to detect the SARS-CoV-2 N gene, while Biocan's immunoassay is designed to detect antibodies against the virus.
Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay is an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.
Under the Emergency Use Authorizations, the RT-PCR tests may be performed by any laboratory CLIA-certified to perform high-complexity testing.
The assay uses RT-PCR and next-generation sequencing to detect coronavirus SARS-CoV-2 nucleic acids from upper respiratory nasal specimens.
While observers are still sorting out the implications of the surprise announcement, it will likely limit the agency's role in regulating LDTs.
The company, which went public in June, has had to deal with issues with the US DOJ, and some private insurers. Its CEO's tenure at Sequenom was also marred by a scandal.
The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.
As the US tries to get more people tested, rapid antigen tests have moved to the forefront of that effort as they can provide results more quickly than PCR-based tests.
The test is designed to detect the ORF1ab and nucleocapsid genes of the virus in upper respiratory specimens such as nasal swabs or nasal aspirates.