Roche receives FDA clearance & CLIA waiver for the cobas® Flu A/B & RSV assay

Roche receives FDA clearance & CLIA waiver for the <strong>cobas</strong><sup>®</sup> Flu A/B & RSV assaycobas Influenza A/B & RSV assay, the third real-time PCR test to deliver lab-quality results in ~ 20 minutes, is now available for use in physician offices.

Roche has announced that the U.S. 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® PCR System.

Coupled with the CLIA-waived cobas Strep A test and the cobas Influenza A/B test, it is the third real-time PCR-based test from Roche that can now be used by healthcare providers in non-traditional laboratory sites, including: physician offices, emergency rooms, health department clinics and other healthcare facilities.

"For young children and the elderly, it’s essential to have a differential diagnosis for RSV and Influenza 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 Influenza and RSV in about 20 minutes, supporting a prompt, confident diagnosis to patients."

In the U.S. an average of 57,527 hospitalizations and 2.1 million outpatient visits in children under 5 years are attributed to RSV. A significant number is also seen in adults over 65 years with 177,000 hospitalizations and 14,000 deaths per yeari. A quick detection and discrimination of influenza and RSV enables clinicians to optimize patient management and antiviral treatment.

View the full press release here.

Visit the cobas® Liat® PCR System page to learn more about the cobas Liat PCR System and the growing menu of real-time PCR-based assays.


References

i CDC RSV Trends and Surveillance. Available at: http://www.cdc.gov/rsv/research/us-surveillance.html. Last accessed 6 June 2016.