FDA clears Diagnostic HYBRIDS' D3 FastPoint L-DFA Respiratory Virus Identification Kit

Diagnostic HYBRIDS, a leading developer of IVD fluorescent staining kits and cell culture products, today announced the U.S. Food and Drug Administration (FDA) (510k) clearance of its D3 FastPoint L-DFA Respiratory Virus Identification Kit, which allows the individual detection of influenza A, influenza B, respiratory syncytial virus (RSV), human metapneumovirus (hMPV), adenovirus and parainfluenza viruses from a patient’s specimen in under 30 minutes.

D3 FastPoint incorporates the same proprietary and proven monoclonal antibodies present in Diagnostic HYBRIDS’ other respiratory virus IVD 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 technology also allows for the simultaneous identification of two respiratory viruses in a single slide well. The 3-well format of the D3 FastPoint L-DFA Respiratory Virus Identification Kit will allow laboratories to simultaneously detect 6 respiratory viruses on a single slide.

The D3 FastPoint L-DFA Respiratory Virus Identification Kit underwent a multi-site trial of nearly 1500 specimens in early 2009. Scientific posters on trial results were presented at the 2009 Clinical Virology Symposium in Daytona Beach, Fla. Abstracts are available at www.virology.org.

“Laboratories across the country are re-evaluating the efficacy of their rapid respiratory testing methods,” said Brooke McCutchan, MT(ASCP), Assistant Director of the Rapid Diagnostic Testing Systems Program at Diagnostic HYBRIDS. “The new D3 FastPoint technology will allow laboratories to provide accurate and rapid results to physicians,” McCutchan added.

“We are thrilled that D3 FastPoint has been cleared for marketing in the US. The D3 FastPoint brand is the logical progression for advancing our current premier DFA products towards a more rapid respiratory testing solution,” said David R. Scholl, Ph.D., President and CEO of Diagnostic HYBRIDS. “As a company, we pride ourselves on responding to customer needs as they arise. Duet fluorescent labels used in this more rapid, user friendly format fills a critical gap that physicians and laboratory practitioners face by delivering DFA performance within the functional timeframe required to impact physician decisions and patient care,” Scholl added.

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