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Roche bags US FDA clearance for cobas pure integrated solutions

cobas pure integrated solutions focuses on the automation of manual tasks, reducing the hands-on maintenance time of technicians to just five minutes per day

Roche received 510(k) clearance from the US Food and Drug Administration (FDA) for the cobas pure integrated solutions, the next generation of innovation in the cobas family of Serum Work Area solutions. The new compact and modular solution combine three technologies – clinical chemistry, immunoassay and Ion-Selective Electrode (ISE) diagnostic testing – on a single platform, helping to optimise space and resources for low- to mid-volume labs to support the delivery of the best patient care.


Built on the latest technology, cobas pure integrated solutions focuses on the automation of manual tasks, reducing the hands-on maintenance time of technicians to just five minutes per day. This can help to improve the productivity of lab personnel while also supporting fast delivery of patient results and clinical decision-making.

Laboratory testing provides essential information for the prevention, diagnosis, treatment and management of the disease. This helps patients receive the best care and highest quality outcomes. The cobas pure system delivers test results in short and predictable turnaround times using low-volume patient samples.

“The cobas pure integrated solutions mark a significant milestone in evolving standardization in lab diagnostics,” said Matt Sause, president and CEO of Roche Diagnostics North America. “Lab professionals are charged with providing life-impacting results quickly, accurately and efficiently. This system delivers a broad menu of medical assays while simplifying operations and reducing hands-on time for laboratorians so that they can focus on the tasks that matter most.”

With a footprint of about 21 square feet, cobas pure integrated solutions are up to 30 per cent smaller than previous generation systems. It can perform up to 870 tests per hour with access to Roche’s full clinical chemistry and immunochemistry assay menu. Within the first year after launch, the menu will include more than 186 diagnostic tests across a wide range of disease areas such as infectious diseases, oncology and cardiology. The system will enable low- to mid-volume labs to make better use of their space and expand their offering of high medical value tests for the benefit of patients.

Furthermore, to ensure effective and efficient work within healthcare networks, the cobas pure system operates seamlessly with Roche’s cobas pro integrated solutions for mid- to high-volume labs. Standardisation helps labs do more work on fewer instruments, deliver consistent results and facilitate flexible staffing strategies through features including consolidated workflows, shared reagent packs, standard reference ranges and common system interfaces. 


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