Diagnostic Hybrids, Inc. Announces FDA Clearance of D3(R) FastPointTM L-DFA(TM) RSV/MPV Identification Kit
1/12/2010 9:59:34 AM
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 RSV/MPV Identification Kit, which allows for the identification of respiratory syncytial virus and human metapneumovirus from a patient’s specimen in under 25 minutes. The D3 FastPoint L-DFA RSV/MPV ID Kit represents the third product in the company’s D3 FastPoint L-DFA product line, and its second cleared MPV testing device. The kit is also the only FDA-cleared product that can be used to detect both RSV and hMPV antigens simultaneously from clinical samples.
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 RSV/MPV Identification Kit will allow laboratories to identify respiratory syncytial virus and metapneumovirus infections in the same timeframe as currently available point-of-care rapid antigen tests, which generally do not include MPV testing options. RSV is the leading cause of infectious viral disease in infants and children under the age of 1 and can be severe in patients with cardiac anomalies1. Human metapneumovirus causes significant disease in all age groups, but particularly in children and elderly adults2.
“The D3 FastPoint L-DFA RSV/MPV Identification Kit provides any laboratory receiving and processing samples from pediatric or geriatric patients with a means to rapidly and accurately detect and identify two of the most significant respiratory viruses for those patient populations,” said Steve Ewers, Senior Product Manager at Diagnostic Hybrids. “This sensitive, accurate result in less than 25 minutes can support the diagnostic algorithm in a clinically relevant timeframe,” Ewers added.
“This new product is an excellent complement to our D3 FastPoint portfolio of rapid testing products,” said David R. Scholl, Ph.D., President & CEO of Diagnostic Hybrids. “With the D3 FastPoint RSV/MPV kit, we are able to provide improved rapid respiratory testing solutions to laboratories focused on respiratory syncytial virus and metapneumovirus diagnosis for pediatric and geriatric hospitals and clinics,” 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.
1 Centers for Disease Control, http://www.cdc.gov/RSV/about/faq.html
2 Illinois Department of Public Health, http://www.idph.state.il.us/public/hb/hb_hMPV.htm