Diagnostic HYBRIDS Receives FDA Clearance For D3 DFA Metapneumovirus Identification Kit

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals;  Infectious Diseases / Bacteria / Viruses;  Respiratory / Asthma
Article Date: 20 Mar 2009 - 1:00 PDT

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Diagnostic HYBRIDS announces the release of its D3 DFA Metapneumovirus Identification Kit for the U.S. market. The kit is the only FDA-cleared device that detects and identifies human metapneumovirus (MPV) from nasal and nasopharyngeal swabs, aspirates and washes using patent-pending MPV monoclonal antibodies. The D3 DFA Metapneumovirus Identification Kit can be used in direct testing of patient specimens with results in as fast as 15 minutes, or in cell culture with the patented R-MixTM and R-Mix TooTM Mixed FreshCellsTM cell culture systems for overnight results.

Even though human Metapneumovirus has been identified as a significant respiratory pathogen for almost a decade, most laboratories do not routinely test for it. According to Steve Ewers, Senior Product Manager at Diagnostic HYBRIDS, "the primary reason for this has been the absence of an FDA-cleared, reliable rapid assay. The D3 DFA Metapneumovirus Identification Kit provides the laboratory with an easy-to-perform, proven methodology utilizing the same protocol as the gold standard D3 Ultra™ DFA Respiratory Virus Screening & Identification Kit. The consistency in methods will allow for easy integration into the lab workflow."

Ewers added that "metapneumovirus infection is especially prevalent in infants and elderly patients, but is often indistinguishable from RSV infection, making it difficult to prevent cross-infections. The availability of the D3 DFA Metapneumovirus Identification Kit combined with our premier D3 Ultra DFA Respiratory Virus Screening & Identification Kit allows laboratories to identify eight major respiratory viruses in a clinically relevant time frame, allowing physicians to make decisions based on a definitive diagnosis instead of on symptoms alone."

The D3 DFA Metapneumovirus Identification Kit is a major addition to Diagnostic HYBRIDS' rapid respiratory virus testing system. The system includes the R-MixTM and R-Mix TooTM mixed cell culture systems which allow for the rapid isolation of MPV in cell culture, and now the D3 DFA Metapneumovirus Identification Kit. The complete respiratory testing system, including additional D3 DFA respiratory testing kits, is available in the U.S., Canada, and select international markets.

About Diagnostic HYBRIDS

Diagnostic HYBRIDS invents, develops, manufactures, and sells innovative diagnostic and analytical products for a wide range of viral respiratory diseases, herpes virus infections, and other specific viral and thyroid diseases. The company also develops and commercializes innovative and genetically engineered cell-based detection products for the pharmaceutical and biotechnology industry, with an initial focus on pharmacology assays and products that measure drug clearance and anti-viral interventions with drugs and vaccines. The company is certified to ISO 13485 standards (2003) and manufactures live continuous and primary cell cultures for clinical diagnostics and pharmacology assays from its headquarters in Athens, OH. Diagnostic HYBRIDS was named one of the 500 Fastest Growing Companies in America in 2004 and 2005 by Inc. Magazine. The company is a pillar member of BioOhio, a statewide organization of bioscience companies accelerating the bioscience and healthcare economy in Ohio.

Diagnostic HYBRIDS