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The EUA from FDA is the first for a diagnostic test for at-home, self-collection of patient samples for detecting the coronavirus and the flu.

The agency said review of Chembio's EUA request was not a priority because it would have a limited impact on testing capacity.

The test originally received Emergency Use Authorization in February for the detection of SARS-CoV-2 nucleic acid in upper and lower respiratory specimens.

Test capacity, particularly for rapid antigen testing, is set to explode in Q1 2021, but home and asymptomatic assays remain few and far between.

Innovita Biological is also developing a rapid, at-home SARS-CoV-2 serology test that it licensed to Scanwell Health earlier this year.

The company is currently selling an at-home sample collection kit that hasn't received premarket approval or investigational device exemption from the agency. 

The FDA last week also reissued an EUA for a PCR-based SARS-CoV-2 test from Quest Diagnostics to permit its use with pooled samples.

The RT-PCR-based test was first authorized earlier this year for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.

The FDA also reissued Emergency Use Authorizations for SARS-CoV-2 tests from Roche and Express Gene to reflect their permitted use with additional sample types.

The ELISA-based test has shown 98.8 percent sensitivity and 99.6 percent specificity for detecting SARS-CoV-2 specific IgG against two virus antigens.

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