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Roche Infectious Disease Tests for New Molecular Instrument Nab CE Mark

NEW YORK – Roche announced on Wednesday that four of its molecular infectious disease tests for use on its new Cobas 5800 instrument have received CE marking. 

The firm is launching its Cobas HIV-1, hepatitis B, hepatitis C, and HIV-1/HIV-2 qualitative tests for use with the compact, PCR-based Cobas 5800 in countries accepting the CE mark, it said in a statement. The Cobas Omni Utility Channel kit — which consolidates open channel tests and Roche in vitro diagnostic tests onto a single platform — also received CE marking. Those open channel tests include IVD assays, research tests, and routine laboratory developed tests, Roche said.

Roche's Cobas HIV-1 test amplifies and detects two separate regions of the HIV-1 genome from blood, while the HIV-1/HIV-2 qualitative assay detects and differentiates between HIV-1 and HIV-2 in human serum, plasma, and dried blood spots. The firm's HCV test quantifies hepatitis C RNA in blood to determine a patient's response to antiviral therapy. 

"We are pleased that we can increase access to accurate, timely, and reliable diagnostics with our first tests on the Cobas 5800 System to patients and their healthcare teams to meet evolving testing demands," Cindy Perettie, head of the Molecular Lab Customer Area at Roche Diagnostics, said in a statement.

The fully automated Cobas 5800 instrument will offer the same menu as Roche's Cobas 6800 and 8800 systems, and the company is pursuing CE approval for other tests, including its Cobas SARS-CoV-2 assay, through mid-2022. The firm said it anticipates tests to be available beyond CE markets next year. 

The instrument can provide up to 144 results in eight hours and encompasses sample supply, transfer, and preparation, along with amplification and detection, result calculation, and delivery to the lab's information system.

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