NEW YORK – Roche on Friday announced that it has received CE marking for an updated version of its high-throughput PCR-based Cobas 6800/8800 platform.
The Cobas 6800/8800 systems 2.0 enhances throughput and run flexibility and enables sample prioritization, Roche said in a statement. It is available as an upgrade to the existing Cobas 6800/8800 systems, and the majority of the Cobas test menu is available with the release of the update.
The new version of the system "significantly enhances the efficiency of laboratories by optimizing resources, reducing downtime, consolidating test menus, and increasing throughput," Roche said.
Roche's new Temperature-Activated Generation of Signal technology, which is used in its 12-target respiratory virus test, is also available on the updated system.
"With our history of leading innovation in automated molecular testing, it represents another competitive leap forward in our efforts to advance PCR technology by combining unprecedented throughput together with the flexibility that laboratories require to deliver for physicians and patients," Roche Diagnostics CEO Matt Sause said in a statement.
The Basel, Switzerland-based company plans to submit the upgraded system to the US Food and Drug Administration for 510(k) approval in 2025.