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FDA Clears ABI Molecular Diagnostics Instrument for Use with New Flu Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing a new molecular diagnostics instrument made by Applied Biosystems for use with a new flu virus panel, ABI announced today.
 
The 7500 Fast Dx Real-Time PCR Instrument is ABI’s first real-time PCR instrument to receive 510(k) clearance. It has been cleared for use with the new CDC Human Influenza Virus Real-Time PCR Detection and Characterization Panel. The assay and instrument were cleared separately but are required to be used together as a system for detecting influenza, said ABI.
 
The test was developed through a collaboration between the US Centers for Disease Control and Prevention and ABI. It can detect and identify commonly circulating human influenza viruses and avian influenza A viruses within four hours and in multiple samples at one time.
 
ABI President and COO Mark Stevenson called the FDA clearance “an important milestone” for the firm “as it presents us with an exciting opportunity to apply our technology to the rapidly growing clinical diagnostics market.”
 
ABI said that CDC-qualified labs that have already purchased a 7500 Real-Time PCR System can contact a company representative about a Dx upgrade.

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