Skip to main content
Premium Trial:

Request an Annual Quote

FDA Clears Roche High-Volume Testing Immunoassay Solution

NEW YORK (360Dx) – The US Food and Drug Administration has cleared Roche's Cobas e 801 module, a new dedicated high-volume testing immunoassay solution, Roche said today.

The new module is for the Cobas 8000 modular analyzer series.

According to Roche, the module "offers greater testing efficiency, superior reagent management, and industry-leading turnaround time for critical diagnostic tests." It allows for continuous, on-the-fly loading of reagents and consumables with a high uptime, while requiring less hands-on time. A new reagent pack design increases reagent onboard stability to 16 weeks, Roche said, resulting in reduced send-out testing and minimized reagent waste for labs.

The company added that the Cobas e 801 module nearly doubles the available immunoassay testing capacity on the same footprint, and delivers up to 300 tests per hour, while providing 48 reagent channels. The module uses at least 25 percent less patient sample than its predecessor, Roche said.