New Molecular Diagnostic System to Expand Access to PCR Testing in the U.S.

S. launch of the cobas 5800 System, a compact, fully-automated molecular laboratory instrument that offers a flexible, PCR testing solution that aids clinicians in diagnosis of infectious diseases. Built upon the proven technology platform of the cobas 6800/8800 Systems, the cobas 5800 is designed to provide optimized workflow efficiencies, simplicity and timely results that can benefit labs of all sizes.

The company has received U.S. Food and Drug Administration premarket approval for the cobas HIV-1 assay, the first in the cobas x800 family of assays available for use on the cobas 5800 System, a Class 2 exempt medical device. The new system and assay will become commercially available in Q4, 2022. Laboratories are facing unprecedented challenges from staffing shortages, to evolving patient testing needs for COVID-19, and are looking for innovative solutions that allow them to do more with limited resources and space. The cobas 5800 will bring a shared clinical menu of molecular diagnostics testing capabilities to smaller and mid-size labs, and flexibility to larger labs that may use cobas 6800/8800 or systems from other vendors.

"We are pleased to provide the cobas 5800 to expand our molecular portfolio with a flexible solution to meet the needs of labs and health systems serving communities throughout the U.S.," said Matt Sause, president and CEO of Roche Diagnostics North America. "The new system furthers our commitment to improve patient care by broadening access to high quality test results so clinicians can make the best treatment decisions for their patients."

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