Roche announced plans for the U.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.
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, and will be showcased at the Association for Molecular Pathology 2022 Annual Meeting and Expo, November 1-5 in Phoenix, Arizona (Booth #1101).
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.
