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Focus Diagnostics gets FDA nod for new flu test

The process efficiently and accurately identifies several respiratory viruses.

BY CAITLIN ADAMSPublished: December 02, 2010 09:33 AM

The U.S. Food and Drug Administration has cleared a new testing kit designed by Focus Diagnostics that speeds the process of identifying influenza and respiratory viruses. The Cypress-based subsidiary of Quest Diagnostics developed the Simplexa test, which distinguishes between influenza A, influenza B and respiratory syncytial virus – or RSV – infection in its results.

The new testing procedure is more efficient than other methods of diagnosis because it does not require secondary confirmation of the test’s results through a specimen culture.

Dr. Jay M. Lieberman, medical director for infectious diseases at Quest and Focus, said diagnosis of influenza and RSV can prove challenging to physicians because their symptoms often mimic those of infections caused by other respiratory viruses.

"Influenza and RSV are two leading causes of respiratory tract infections in the U.S. and globally, infecting many millions of patients each year,” said Lieberman. “These viruses sometimes cause severe illness and even death, particularly in infants and young children, older adults, and people with underlying health problems. Our highly sensitive Simplexa test will help physicians quickly and reliably diagnose respiratory illness due to influenza or RSV, to help them better manage their patients."

The new testing kit is the second Simplexa product developed by Focus Diagnostics. In May, the firm secured FDA clearance for its Simplexa Influenza A H1N1 test, which identifies strains of swine flu and other influenza A viruses.

"Our Simplexa test line can empower hospital, urgent-care clinics and other labs to perform highly advanced molecular testing close to their patients for faster reporting of results," said Focus Vice President and General Manager John G. Hurrell. "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."

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