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DiaCarta Gets FDA Emergency Use Authorization for Coronavirus PCR Test

NEW YORK – DiaCarta said on Thursday that it has obtained Emergency Use Authorization from the US Food and Drug Administration for its QuantiVirus PCR diagnostic (Dx) test for the novel coronavirus.

The test detects the N, Orf1ab, and E genes of the SARS-CoV-2 virus in nasopharyngeal swabs, oropharyngeal swabs, and sputum samples from individuals suspected by their healthcare providers of having COVID-19. It uses real-time quantitative reverse transcriptase PCR and has a limit of detection of 100 copies/mL without detectable cross-reactivity to other human respiratory pathogens.

The assay, which is also CE marked, can be used with commonly available qPCR instruments, such as Thermo Fisher Scientific's Applied Biosystems 7500 and QuantStudio 5. CLIA labs that are certified to perform high-complexity tests can now use the test.

DiaCarta said it has recently expanded its manufacturing capacity to 500,000 tests per week and is planning to increase it another fourfold to meet the increasing demand for coronavirus PCR tests.