Roche has received the CE mark certification for its newly updated cobas 6800/8800 systems 2.0, improving laboratories and testing capabilities.
The upgrade of the systems is set to optimise laboratory resources, decrease downtime, consolidate test menus, and increase throughput, offering more diagnostics experience for patients and healthcare professionals.
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The cobas 6800/8800 systems are tailored to meet the needs of mid-to-high-volume molecular testing laboratories. They claim to offer intelligent workflows, performance, throughput, and established reliability and flexibility.
Temperature-activated generation of signal (TAGS) technology, along with most of the cobas test menu, is available with the release of the upgrade.
The company’s TAGS technology allows for the simultaneous identification of up to 15 targets in a single patient sample on the cobas 5800, 6800, and 8800 molecular diagnostic analyser systems.
It is designed to differentiate up to three targets per fluorescence channel. The technology surpasses the technical limitations of typical 4-plex test outcomes found in prior solutions, leveraging a new approach.
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By GlobalDataRoche Diagnostics CEO Matt Sause said: “This update marks another significant milestone for Roche.
“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.”
Labs with existing cobas 5800, 6800, and 8800 systems can instantly deliver quick, precise, high throughput flexible syndromic multiplex PCR testing to central laboratories eliminating the need for hardware or software upgradation.
The upgrade also aligns the ‘cobas family of solutions’, offering a combined user experience including innovations from the cobas 5800 system.
Looking ahead, the company plans to seek 510(k) clearance from the US Food and Drug Administration (FDA), with submission expected in the coming year.
In November 2022, Roche received emergency use authorisation from the FDA for its mpox virus detection test, cobas MPXV, for use on the cobas 6800/8800 Systems.
