Roche receives FDA clearance for new high-volume testing immunoassay solution

Roche announced today that its new, dedicated high-volume testing immunoassay solution for the cobas 8000 modular analyzer series, the cobas e 801 module, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).

As core laboratories continue to evolve to meet the growing workload demands in an increasingly challenging environment, the cobas e 801 module offers greater testing efficiency, superior reagent management and industry-leading turnaround time for critical diagnostic tests. Designed for maximum consolidation at a high throughput, the module reduces generated waste, for more environmentally sustainable testing.

"The cobas e 801 module truly is a transformative solution," said Dr. Alan Wright, Chief Medical Officer, Roche Diagnostics Corporation. "Patients and the physicians who serve them need medically relevant answers, faster and with ever greater precision. This clearance delivers the instrumentation cornerstone of the next-generation lab-;high throughput, agility and intelligence."

The cobas e 801 module almost doubles the currently available immunoassay testing capacity on the same footprint, delivering up to 300 tests per hour and providing 48 reagent channels.

Designed to use at least 25% less patient sample than its predecessor, the analyzer offers an extensive assay menu and delivers speed, accuracy and consistency.

Advances that speed patient care

The cobas e 801 module is the newest member of the cobas 8000 modular analyzer series, delivering immunoassay testing across a wide range of disease areas. Up to four cobas e 801 modules can be configured in a series, delivering up to 1,200 tests per hour across up to 192 reagent positions. The system may also be integrated with the cobas 8100 automated workflow series and Roche Middleware featuring Lab Intelligence.

The cobas e 801 module allows for continuous, on-the-fly loading of reagents and consumables and has a high uptime, while requiring less hands-on time. A new reagent pack design has increased reagent onboard stability to 16 weeks, allowing labs to reduce send-out testing and minimize reagent waste.

The cobas e 801 module will continue to deliver Roche's industry-leading 9-minute STAT assays, allowing labs to reduce turnaround time for critical testing, such as cardiac markers. The small sample volumes required for testing are beneficial for patients, especially special populations like pediatrics and the critically ill.​