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The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.
The RT-PCR test runs on Roche's automated Cobas 6800/8800 systems and is also available in countries accepting the CE mark.
The point-of-care test provides results in 15 minutes and can be used for both symptomatic and asymptomatic patients.
The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, enabling appropriate treatment options.
The FDA does not allow labs to report hs-troponin results below assays' limits of quantitation, which some argue leaves actionable information on the table.
The PCR viral load test runs on the Cobas 6800/8800 systems and has been calibrated to the World Health Organization International Standard, Roche said.
A SNP in the pan-SARS E gene has not affected patient results, but has raised concerns about the overall unavailability of commercial primer and probe information.
The test detects the HER2 biomarker in breast cancer and can be completed within the same day, allowing for faster results than other HER2 testing methods.
The coming uptick in flu and other respiratory viruses will likely complicate the diagnosis of COVID-19 even as labs continue to struggle with capacity.
The firm currently has seven available products, including high- and low-throughput molecular tests and an antibody test for the virus.