This product is one of several assays from Quidel's expanding molecular diagnostics programs. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with their existing thermocyclers. These kits include unique features that provide for simple transport and storage, ease-of-use, an attractive workflow, a short time to result and other benefits that favorably affect diagnostic test outcome.
Quidel received FDA clearance in December to run its Quidel Molecular Influenza A+B and hMPV assays on Life Technologies' Applied Biosystems(R) 7500 Fast DX thermocycler.
"We are very pleased to receive FDA clearance to run our molecular flu test on Cepheid's SmartCycler," said Douglas Bryant, president and chief executive officer of Quidel Corporation.
"This claim will provide health care workers in established molecular laboratories with a versatile, high-performance diagnostic product without making additional investments in their molecular infrastructure."
The product was launched in Europe for use with both thermocyclers shortly after receiving the CE Mark in August 2011.