FDA grants 510(k) clearance to Focus Diagnostics Simplexa Flu A/B & RSV test on 3M Integrated Cycler

Quest Diagnostics Incorporated (NYSE: DGX), the world's leading provider of diagnostic testing, information and services, today announced that the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance to the Focus Diagnostics Simplexa Flu A/B & RSV test on the 3M™ Integrated Cycler. The Simplexa test, developed and manufactured by Quest Diagnostics' Focus Diagnostics business, is intended as an aid in the detection and discrimination of influenza A, influenza B and RSV virus infections.  

It is the first molecular test cleared 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. In addition, the time to perform the Simplexa test following RNA extraction from a specimen takes only about an hour, with results expected to be reported in less than three hours following receipt of a specimen.

"Influenza and RSV are two leading causes of respiratory tract infections in the U.S. and globally, infecting many millions of patients each year. These viruses sometimes cause severe illness and even death, particularly in infants and young children, older adults and people with underlying health problems," said Jay M. Lieberman, M.D., medical director, infectious diseases, Quest Diagnostics and Focus Diagnostics. "Infection with these viruses can be challenging to diagnose because their signs and symptoms often mimic infection by other respiratory viruses. 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 Simplexa tests employ real-time reverse transcription (RT) polymerase chain reaction (PCR) to qualitatively detect RNA of the influenza A or B viruses or RSV in a patient's nasal or nasopharyngeal specimens. The Simplexa Flu A/B & RSV test reports if a patient is positive or negative for infection with one or more of the three classes of viruses.

Results of a clinical study presented to the FDA in the 510(k) filing found the Simplexa test performed comparably to predicate devices in detecting the target viruses in patient specimens.

The new test is the second from the Simplexa product line of RT-PCR molecular test kits that run on the 3M integrated Cycler as part of an exclusive global distribution agreement between Focus Diagnostics and 3M (NYSE: MMM). In May 2010, the Simplexa Influenza A H1N1 (2009) test on the 3M Integrated Cycler was the first commercial RT-PCR test to receive FDA clearance for the detection and differentiation of the 2009 H1N1 influenza 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 John G. Hurrell, Ph.D., vice president and general manager, Focus Diagnostics. "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."