FDA authorises Roche’s cobas pro solutions for diagnostic labs

16 September 2019 (Last Updated September 16th, 2019 14:22)

Roche has received the US Food and Drug Administration (FDA) clearance for its cobas pro integrated solutions to support operations in diagnostic laboratories.

FDA authorises Roche’s cobas pro solutions for diagnostic labs
Compared with cobas 6000, the cobas pro solutions are claimed to cut operating time by approximately 3¼ hours for a daily routine workload. Credit: F. Hoffmann-La Roche Ltd.

Roche has received the US Food and Drug Administration (FDA) clearance for its cobas pro integrated solutions to support operations in diagnostic laboratories.

The products are said to be a next-generation laboratory solution of Serum Work Area clinical chemistry and immunochemistry.

According to Roche, the cobas pro solutions enable quick testing on less equipment, automate manual tasks and deliver rapid results to facilitate treatment decisions.

Diagnostic laboratories are a fundamental part of the global healthcare system. Up to 70% of all clinical decisions are influenced by in-vitro diagnostics that contribute to only 2% of healthcare spending.

To improve efficiency, Roche designed the laboratory solution to run up to 2,200 tests per hour with three simultaneously working modules.

The cobas pro integrated solutions also cut operating time by approximately 3¼ hours for a daily routine workload compared with the cobas 6000 system. The immunoassays by the company have reaction times of 18 minutes or less.

This reduced time is expected to aid in clinical decision making across various therapeutic areas such as core lab / HIV testing, pregnancy and blood screening.

Roche Diagnostics CEO Thomas Schinecker said: “We are excited about the accelerated FDA clearance of the cobas pro integrated solutions. Our new generation of Serum Work Area solutions inspired by our mission to help improve the speed and reliability of treatment decisions for patients and their families.

“Reliable, fast and sustainable diagnostic solutions are vital for optimal clinical care delivery for patients and a key element in the evolution of general healthcare quality.”

The company launched the cobas pro integrated solutions in European markets in January, following the receipt of CE-Mark approval.