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FDA Clears Quest's Respiratory Virus Molecular Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing a molecular respiratory virus test made by Quest Diagnostics' Focus Diagnostics business, the firm said today.

The agency granted 510(k) clearance for the Focus Diagnostics Simplexa Flu A/B & RSV test for use on the 3M Integrated Cycler. The Simplexa RT-PCR test is intended to aid in the detection and discrimination of influenza A, influenza B, and respiratory syncytial virus infections.

According to Quest, it is the first molecular test approved by the FDA for detecting flu viruses and RSV that does not require confirmation of test results by other time-consuming methods, such as culture. The time to perform the Simplexa test following RNA extraction from a specimen takes about an hour, said Quest, with results expected to be reported in less than three hours.

The Simplexa test uses nasal or nasopharyngeal specimens and reports if a patient is positive or negative for infection with one or more of the three classes of viruses.

"For many physicians and lab administrators, it will eliminate the time-consuming step of sending a specimen to a reference lab for molecular testing to detect flu and RSV infection," John Hurrell, VP and GM of Focus Diagnostics, said in a statement.

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