Nov. 9, 2022—Roche announced plans for the U.S. launch of the Cobas 5800 system, a compact, fully-automated molecular instrument that aims to offer a flexible, PCR testing solution to help clinicians diagnose infectious diseases.
The Cobas 5800 system allows labs to test multiple assays simultaneously, delivers up to 144 results in an eight-hour shift, and has a walkaway time of up to eight hours. The system’s workflow encompasses sample transfer and preparation, amplification and detection, result calculation, and delivery to the laboratory information system.
Roche received FDA premarket approval for the Cobas HIV-1 assay, the first in the Cobas x800 family of assays available for use on the Cobas 5800, which is a class II–exempt medical device. The new system and assay will be commercially available in the fourth quarter of this year.