TUESDAY, SEPTEMBER 27, 2016

Remel Xpect Flu A&B granted FDA clearance

Thermo Fisher Scientific, Inc., announced on Monday that its Remel Xpect Flu A&B assay was granted clearance by the FDA for assessing detection of emerging viruses.

The Remel Xpect Flu A&B assay is currently able to find culture avian influenza A and its analytical reactivity testing was shown to be in line for the FDA reclassification proposal that would allow for Remel Xpect Flu A&B to be used for assessing detection of emerging viruses that might cause a public health emergency.

"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," Rob Spignesi, the vice president and general manager for microbiology Americas at Thermo Fisher Scientific, said. "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."

Xpect Flu A&B is able to, with rapid laboratory results, give early diagnosis and identification to patients who might be able to benefit from quick antiviral treatments. It can also distinguish between influenza A and B types, but cannot distinguish between the subtypes.