Roche today announced that the U.S. Food and Drug Administration (FDA) has granted CLIA (Clinical Laboratory Improvement Amendments) waiver for the cobas® Influenza A/B test for use on the cobas® Liat System.
It is the first CLIA-waived, real-time polymerase chain reaction (PCR) test to detect influenza A and B in ~20 minutes. Coupled with the CLIA waived cobas Strep A test, the cobas Influenza A/B test can now be used by healthcare providers in non-traditional testing sites, including physician offices, emergency rooms, health department clinics, pharmacy clinics and other healthcare facilities.
“Today’s CLIA waiver for the cobas Influenza A/B test allows real-time PCR technology, the gold standard in molecular testing, to be utilized at the point of care to accurately and quickly detect and differentiate influenza A and B,” said Roland Diggelmann, COO, Roche Diagnostics. “Effective management of influenza relies on accurate detection within 48 hours of onset, which can be challenging with current turnaround times for lab-based test results. The cobas Influenza A/B test provides lab-quality PCR results in ~20 minutes, enabling health care providers in all settings to give prompt and confident diagnosis and treatment to patients.”
An estimated three to five million individuals develop influenza each year worldwide, and 250,000 to 500,000 die from the virus. Patients at highest risk include children, the elderly and pregnant women. The CLIA waived cobas Influenza A/B test for the cobas Liat PCR System offers an effective, new diagnostic tool to clinicians for the upcoming flu season and provides faster diagnosis and treatment for patients in primary and urgent care settings.
The cobas Influenza A/B test is the second assay on the cobas Liat System to receive CLIA waiver, following the cobas Strep A test, which received CLIA waiver in May 2015. The cobasLiat Analyzer, cobas Influenza A/B test and cobas Strep A test are CE Marked, FDA cleared and CLIA waived.