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The firm said being able to test asymptomatic people with its Panther Fusion SARS-CoV-2 assay could play an important role in reopening the economy.
The test runs on multiple GeneXpert systems and tests nasopharyngeal and nasal swabs or nasal wash/aspirate specimens.
The firm said that the shortage of testing in rural America highlights a need for its rapid molecular system, which is small enough to fit in a backpack.
Both RT-PCR tests are for the simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B from throat swab samples.
Revenues have begun to recover in Q3, driven by a ramp in SARS-CoV-2 testing, and the firm now expects full-year 2020 revenues to exceed its prior guidance.
The firm's assay is also CE marked for use with nasal swabs, nasopharyngeal swabs, nasal wash and aspirates, and bronchoalveolar lavages.
The test can be used directly on any open instrument, including portable systems, and it allows for detection of pathogens in about 75 minutes.
Florida's largest county joins several major California counties in deploying Fulgent Genetics' PCR-based COVID-19 tests in a drive-through setting.
The company's contract with the NIH offered $12 million total and after initial test verification, Fluidigm will receive approximately $11 million.
The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.