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Diagnostic Hybrids, Inc. Announces FDA Clearance of D3(R) FastPointTM L-DFATM Influenza A/ Influenza B Virus Identification Kit


10/27/2009 2:33:33 PM

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ATHENS, Ohio--(BUSINESS WIRE)--Diagnostic Hybrids, a leading developer of in vitro diagnostic fluorescent staining kits and cell culture products, announces the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPointTM L-DFATM Influenza A/ Influenza B Virus Identification Kit, which allows for the identification of influenza A virus and influenza B virus from a patient’s specimen in under 30 minutes. The D3 FastPoint L-DFA Influenza A/ Influenza B Virus ID Kit represents the second product in the company’s D3 FastPoint L-DFA product line.

D3 FastPoint incorporates the same proprietary and proven monoclonal antibodies present in Diagnostic Hybrids’ other respiratory virus products. The kit uses the fluorescent labeling technologies of the company’s D3 UltraTM and D3 DuetTM product lines in combination with newly developed L-DFA processing technology to create a unique rapid testing format. The new patent-pending L-DFA technology also allows for the simultaneous identification of two respiratory viruses in a single slide well. The D3 FastPoint L-DFA Influenza A/ Influenza B Virus Identification Kit will allow laboratories to identify influenza A virus and influenza B virus infections in the same timeframe as currently available point-of-care rapid antigen tests.

“The D3 FastPoint Flu A/B kit allows laboratories to report DFA quality results within the critical care window, while confirming the specimen adequacy to avoid false negatives due to poor specimen collection, which is not possible when using rapid antigen tests,” said Brooke McCutchan, MT (ASCP), Assistant Director of the Rapid Diagnostic Testing Systems Program at Diagnostic Hybrids.

“This next product in the D3 FastPoint line is the logical progression for advancing our premier L-DFA products towards a more useful alternative to rapid antigen cartridge tests,” said David R. Scholl, Ph.D., President & CEO of Diagnostic Hybrids. “With the D3 FastPoint Flu A/B kit, we are able to provide improved rapid respiratory testing solutions to laboratories focused on influenza A virus and influenza B virus diagnosis,” Scholl added.

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 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. For more information, please visit www.dhiusa.com.

Photos/Multimedia Gallery Available: http://www.businesswire.com/cgi-bin/mmg.cgi?eid=6084498&lang=en Contacts

Diagnostic Hybrids Christina Dierkes, Coordinator, Marketing Communications & Public Relations, 740-589-3300 christina_dierkes@dhiusa.com



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