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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.
The company is drawing on its previous experience developing and commercializing its HIV self-test to make progress on a test that could be used for three different indications.
The loop-mediated isothermal amplification test runs on a battery-powered device to provide self-testing individuals with results in approximately 30 minutes.
Adaptive is rebranding its immunoSeq Dx assay as T-Detect and plans to submit for an EUA for a COVID-19 T-Cell response test by the end of the year.
The assay is the first SARS-CoV-2 neutralizing antibody test to receive Emergency Use Authorization from the FDA.
Fluidigm tallied $39.9 million in revenues compared to $26.5 million a year ago, and well above analysts' consensus estimate of $32.5 million.
The RT-PCR-based test was first authorized in March for the detection of SARS-CoV-2 nucleic acid in specimens collected by a healthcare provider.
The firm's molecular solutions revenues increased 79 percent to $31.7 million due to COVID-19 testing demand.
The test was first authorized in May for the detection of the SARS-CoV-2 N, E, and ORF1a genes in nasopharyngeal swabs and other specimens.