Roche secures FDA approval and CLIA waiver for cobas Influenza A/B & RSV test

31 July 2016 (Last Updated July 31st, 2016 18:30)

US-based medical device company Roche has secured 510(k) clearance from the US Food and Drug Administration (FDA) and clinical laboratory improvement amendments (CLIA) waiver for its cobas Influenza A/B & RSV test to be used on the cobas Liat system.

US-based medical device company Roche has secured 510(k) clearance from the US Food and Drug Administration (FDA) and clinical laboratory improvement amendments (CLIA) waiver for its cobas Influenza A/B & RSV test to be used on the cobas Liat system.

The cobas Influenza A/B & RSV test is based on real-time polymerase chain reaction (PCR) technology to detect and classify influenza A virus RNA, influenza B virus RNA and respiratory syncytial virus (RSV) RNA in about 20 minutes.

Roche Molecular Diagnostics head Uwe Oberlaender said: "For young children and the elderly, it is essential to have a differential diagnosis for RSV and flu to ensure appropriate treatment within a short time frame after symptoms strike.

"The cobas Influenza A/B & RSV test provides lab-quality PCR results for flu and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients."

"This can be challenging with current turnaround times for lab-based test results.

“The cobas Influenza A/B & RSV test provides lab-quality PCR results for flu and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients."

Real-time PCR is considered as the gold standard for molecular testing offering an accurate and a low-limit of detection (LOD) to identify viruses in patients with low-viral load, such as in some adults with influenza infection.

The test reaches the well-conserved regions of influenza A, influenza B and RSV RNA offering a broad strain coverage and can detect more than 40 commonly found strains of influenza A and B and seven commonly found strains of RSV.

The cobas liat system automates the testing process and simplifies workflow while allowing healthcare professionals perform molecular testing with speed, reliability and minimal training.