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Thermo Fisher Scientific (TMO)'s Xpect Flu A&B Assay Achieves FDA Clearance for Novel Avian Influenza A (H7N9) Analytical Reactivity Label Claims



9/30/2013 7:06:25 AM

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Xpect Flu A&B Assay Achieves FDA Clearance for Novel Avian Influenza A (H7N9) Analytical Reactivity Label Claims

LENEXA, Kan.--(BUSINESS WIRE)--Analytical sensitivity data shows Thermo Fisher Scientific’s Remel Xpect Flu A&B assay is able to detect cultured avian influenza A (H7N9), A/Anhui/1/2013 virus. Analytical reactivity testing for this novel strain is in line with the FDA reclassification proposal for assessing detection of emerging viruses that could potentially cause a public health emergency.

An outbreak in April of the novel influenza A (H7N9) virus infected more than 130 people, and resulted in at least 43 deaths1. While human infections have been limited to China, officials are remaining vigilant in monitoring the virus due to the pandemic potential.

Rapid laboratory results from Xpect Flu A&B facilitate early diagnosis and identification of patients who may benefit from appropriate antiviral treatment. This not only has the potential to shorten the duration and severity of illness, but also reduces the misuse of antibiotics.

“Rapid influenza tests provide quick and clinically useful results to allow for proper treatment on an individual level and an appropriate response at the public health level, which is imperative when managing a novel and particularly virulent virus,” stated Rob Spignesi, vice president and general manager for microbiology, Americas, for Thermo Fisher Scientific. “Ensuring our Xpect Flu A&B assay effectively detects emerging and potentially threatening influenza viruses is a top priority for Thermo Fisher Scientific, and being able to add this information to label claims is an important accomplishment that we are proud to announce.”

While Xpect Flu A&B can distinguish influenza A and influenza B, it cannot differentiate influenza subtypes, such as influenza A (H7N9). Performance with clinical specimens from patients infected with influenza A (H7N9) has not been established.

In addition to the Xpect Flu A&B assay, Thermo Fisher Scientific provides a broad range of products for respiratory testing, including Xpect RSV, MicroTestTM viral transport, and collection swabs.

http://www.cdc.gov/flu/avianflu/h7n9-virus.htm as of August 6, 2013

About Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $13 billion, we have 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.

Contacts

Thermo Fisher Scientific Inc.

Tom Keppeler, 781-622-1371

tom.keppeler@thermofisher.com

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