Roche has announced plans for the US 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 optimised workflow efficiencies, simplicity and timely results that can benefit laboratories of all sizes.
The company has received US 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 the fourth quarter of 2022.
The cobas 5800 will bring a shared clinical menu of molecular diagnostics testing capabilities to smaller and mid-size laboratories, and flexibility to larger ones 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 laboratories and health systems serving communities throughout the US," 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."
The cobas 5800 System is a real-time molecular testing solution that provides excellent performance and value-added utility from a compact footprint. The cobas 5800 System delivers automation, consolidation, integration and standardisation.
The system is built to offer a fully automated workflow that encompasses sample transfer and preparation, amplification and detection, result calculation and delivery to the laboratory information system. Designed as one integrated instrument, the cobas 5800 System enables a walkaway time of up to eight hours, resulting in reduced hands-on time, which can lead to improved productivity, reduced possibility for errors and more predictable turnaround times.
The cobas 5800 System offers an expanded on-board capacity allowing labs to test multiple assays simultaneously and delivers up to 144 results in an eight-hour shift. This streamlined molecular testing system will allow most labs to consolidate greater than 90% of their routine molecular tests onto a single platform. For more information please visit diagnostics.roche.com.