Roche’s real-time polymerase chain reaction test for the detection of influenza A and B has now officially been approved due to a Clinical Laboratory Improvement Amendments waiver.
The waiver exempted the tests from a set of regulations from the federal Centers for Medicare & Medicaid Services.
“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 Roche Diagnostics COO Roland Diggelmann in a statement, as Fierce reported. “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.”
Together with the cobas Liat PCR system, the cobas Influenza A/B test can reportedly differentiate the virus type in about 20 minutes.
The FDA has plans to play a bigger role in regulation of diagnostics, and this regulatory move fits into that plan.
Photo: Flickr user mcfarlandmo
