Roche's ($RHHBY) real-time polymerase chain reaction tests for the detection of influenza A and B can now be used in settings such as the emergency room, pharmacies and physicians' offices, thanks to a CLIA waiver exempting it from a set of regulations on large diagnostic laboratories carried out by the federal Centers for Medicare & Medicaid Services.
|Roland Diggelmann, COO of Roche Diagnostics Global--Courtesy of Roche|
"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. "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."
The cobas Influenza A/B test is used in conjunction with the cobas Liat PCR System. It detects and differentiates between the RNA of influenza A and B virus in about 20 minutes.
The company says the disease afflicts 3 million to 5 million people per year globally and kills 250,000 to 500,000.
The influenza diagnostic is the second CLIA-waived test carried out on the cobas Liat System. Roche's cobas Strep A test obtained a CLIA waiver earlier this year.
In May, Roche got FDA clearance for its rapid test for the Clostridium difficile, broadening its offerings on the cobas 4800 system.
The regulatory moves come in the context of FDA's plan to play a bigger role in the regulation of diagnostics, replacing the current two-track system in which providers of testing services are regulated by the CLIA rules, while those that sell testing kits to third parties utilize the FDA approval or clearance pathway.
Industry is awaiting a finalization of the FDA's draft guidance, which would mark the start of implementation phase of the regulatory reforms.
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