Business
FDA approves Spectral's rapid West Nile Virus test
FDA approves Spectral's rapid West Nile Virus test.
About this update from Spectral Medical Inc
[{"type":"text","content":"\n\n\n\nTORONTO, Dec. 12 /CNW/ - Spectral Diagnostics Inc. (SDI:TSX) today\nreports that its West Nile Virus IgM STATus(TM) Test has received marketing\napproval from the U.S. Food and Drug Administration (FDA) for clinical use in\npatients with presumptive West Nile Virus (WNV) infection.\n\n\n\"This represents a major accomplishment for our company and is indicative\nof Spectral's unique capabilities in the development of novel diagnostics,\"\nstated Dr. Paul Walker, President and CEO. \"This is the first test that can be\nused to diagnose WNV infection on an individual basis with results available\nin fifteen minutes. Spectral's test will fill a significant unmet clinical\nneed.\" he added.\n\n\nThe U.S. Centers for Disease Control (CDC) reported an increase of more\nthan 34% in the number of confirmed WNV infection cases in 2006 as compared to\n2005. In addition, the CDC reported 135 fatalities from WNV infection.\nPatients with WNV infection may have non-specific symptoms of fever, headache,\nmalaise, or other flu-like symptoms that are difficult for physicians to\ndiagnose. Other current testing practices may take considerably longer time to\nprovide clinical results.\n\n\n\"Spectral plans to make this newly FDA approved test widely available\nwithin the U.S. in time for the 2007 WNV season. We are confident that this\nassay will significantly improve Spectral's growth opportunities,\" stated Rob\nVerhagen, Vice President of Business Development.\n\n\nSpectral is a developer of innovative technologies for comprehensive\ndisease management. Spectral provides accurate and timely information to\nclinicians enabling the early initiation of appropriate and targeted therapy.\nCurrent products include Spectral's FDA approved rapid diagnostic for sepsis,\nthe EAA(TM), the newly approved West Nile Virus IgM STATus(TM) Test, as well\nas a range of other biological reagents. Spectral's common shares are listed\non The Toronto Stock Exchange under the symbol SDI.\n\n\nInformation in this news release that is not current or historically\nfactual information may constitute forward-looking information within the\nmeaning of securities laws. Implicit in this information, the future outlook\nof Spectral, and anticipated events or results are assumptions based on\nbeliefs of Spectral's senior management as well as information currently\nava...