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Roche Receives FDA Clearance and CLIA Waiver

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News

Roche Receives FDA Clearance and CLIA Waiver

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Roche announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance and CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Influenza A/B & RSV test for use on the cobas® Liat® System. Roche is the first manufacturer to extend the value of highly accurate CLIA-waived molecular testing beyond flu A/B and strep A to include Respiratory Syncytial Virus (RSV), a cause of more than 80% of acute lower respiratory tract infections in infants under one year of age.

"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," said Uwe Oberlaender, Head of Roche Molecular Diagnostics. "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."

In the US, an average of 58,000 hospitalizations and 2.1 million outpatient visits in children below five years old are attributed to RSV. A significant number is also seen in adults over 65 years with 177,000 hospitalizations and 14,000 deaths per year. A quick detection and discrimination of flu and RSV enables clinicians to optimize patient management and antiviral treatment.

The cobas® Influenza A/B & RSV test is the third assay on the cobas® Liat® System to receive CLIA waiver, following the cobas® Strep A and cobas® Influenza A/B tests, which received CLIA waiver in May and September 2015, respectively. The cobas® Liat® Analyser and all three assays are FDA cleared and CLIA waived. 

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