FDA approves new Diagnostic HYBRIDS kit, completes respiratory virus line

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 detect other respiratory viruses, spokesman Mike Kornwell said. Respiratory kits make up the company’s top revenue stream.

Diagnostic HYBRIDS, based in Athens, also develops kits to detect sexually transmitted diseases, among other things. In February, Case Western Reserve University in Cleveland, Ohio, announced the licensing of technology that gauges the success of HIV and AIDS treatments to Diagnostic HYBRIDS.

The company, which has a Cleveland office and laboratory, stated in a release that 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.

The kit can produce results on patient specimens in as few as 15 minutes, the company stated. It also can differentiate the metapneuomovirus from another bronchitis-causing virus with which it is often confused.

Human metapneuomovirus has been known as a significant respiratory pathogen for almost a decade, causing the most problems for infants and the elderly. However, most labs don’t test for the virus because they lack an FDA-approved 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.