ATHENS, Ohio — The U.S. Food & Drug Administration approved a new product for Ohio-based Diagnostic HYBRIDS that will identify human metapneumovirus, which is thought to cause some childhood bronchitis, colds and inner-ear infections.
The approval completes a line of kits by Diagnostic HYBRIDS to detectÂ other respiratory viruses, spokesman Mike Kornwell said. Respiratory kits make up the company’s top revenue stream.
Diagnostic HYBRIDS, based in Athens,Â also develops kits to detect sexually transmitted diseases, among other things. In February, Case Western Reserve University in Cleveland, Ohio, announced the licensing of technologyÂ that gauges the success ofÂ HIV and AIDS treatments to Diagnostic HYBRIDS.
The company, whichÂ has a Cleveland office and laboratory,Â stated in a release thatÂ its new D3 DFA Metapneumovirus Identification Kit is the only FDA-cleared device that detects and identifies human metapneumovirus by employing a certain type of antibodies.
TheÂ kit can produceÂ results onÂ patient specimens in as few asÂ 15 minutes, the company stated. It also can differentiate the metapneuomovirusÂ fromÂ another bronchitis-causing virus with which it is often confused.
Human metapneuomovirus has beenÂ known as a significant respiratory pathogen for almost a decade, causing the most problems for infants andÂ the elderly. However, most labs don’t test for the virus becauseÂ they lackÂ an FDA-approvedÂ device that can yield quick results, said Steve Ewers, senior product manager at Diagnostic HYBRIDS, in his company’s release.
Being able to identify human metapneumovirus would enable doctors to make better patient treatment decisions, the company said.
There are other metapneumovirus tests on the market, though. The FDA in January 2008 approved a virus-detection kit for Texas-based Luminex Corp. that included a screening for human metapneumovirus.