SWITZERLAND – Roche has secured the US Food and Drug Administration (FDA) 510(k) approval for cobas pure integrated solutions, its new-generation work area platform intended for low- to mid-volume labs.
The new platform is the latest addition to the company’s cobas family of Serum Work Area solutions.
The compact and modular solution is designed to combine three technologies – clinical chemistry, immunoassay, and Ion-Selective Electrode (ISE) diagnostic testing, on a single platform.
This helps to optimize space and resources for low- to mid-volume labs to support the delivery of the best patient care.
Built on the latest technology the new solution automates the manual tasks and reduces the technicians’ maintenance time to just five minutes per day to improve the productivity of lab personnel, said the company.
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 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.
With a footprint of about 21 square feet, Cobas pure integrated solutions is up to 30% smaller than previous generation systems.
The device can perform up to 870 tests per hour, and access to the Swiss drugmaker’s complete clinical chemistry and immunochemistry assay menu.
Roche claimed that the system uses low-volume patient samples to deliver the test results within short and predictable turnaround times.
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.
It 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, said Roche.
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.
Standardization 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.
The Cobas pure integrated solutions launched in countries accepting the CE mark in March 2021.
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