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Quest Diagnostics’ Subsidiary Receives FDA Approval For Simplexa Flu Test

Quest Diagnostics’ Subsidiary Receives FDA Approval For Simplexa Flu Test

Quest Diagnostics (NYSE: DGX), a provider of diagnostic testing services based in Madison, New Jersey, announced today that the U.S. Food and Drug Administration (FDA) has approved its Focus Diagnostics subsidiary’s Simplexa flu test. 


The Simplexa test is intended to help detect influenza A, influenza B and RSV infections, which can sometimes cause severe illnesses, especially in children.  These viruses can be hard to diagnose since their signs and symptoms are similar to other respiratory viruses. 


According to the U.S. Centers for Disease Control and Prevention, twenty five to 40 percent of infants and young children with RSV infection show signs of pneumonia or bronchiolitis, and it is estimated that between 75,000 and 125,000 children less than one year old are hospitalized each year due to RSV.


According to Quest, it is expected that results from the Simplexa test can be reported in less than three hours after receiving a virus specimen.   


"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,” said John G. Hurrell, Vice President of Focus Diagnostics.


Also, results of a clinical study that was part of the FDA approval process found the Simplexa test performed comparably to other devices in detecting the target viruses.  


Since the announcement, the Quest’s share price has rallied 1.6% to trade at $50.12 as of 2:17 pm EST.

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