TORONTO, Nov. 2 /PRNewswire-FirstCall/ - Spectral Diagnostics Inc. and its joint venture research and development partner, IDx Inc., announced today that they have received notification from the Technology Products Directorate of Health Canada of the approval of the West Nile Virus (WNV) IgM STATus Rapid Test for immediate clinical use.
Dr. Paul Walker, MD PhD, CEO of Spectral stated, “We are pleased to receive regulatory approval for this product in Canada. This product represents a major breakthrough in the ability to rapidly assess the many patients suspected of West Nile Fever or those with West Nile Meningoencephalitis. The ability to make a diagnosis for an individual patient with potential WNV infection in less than an hour will allow doctors and public health personnel to intervene faster and more effectively manage WNV infection. To date, Spectral’s West Nile Virus diagnostic is the only rapid point of care test intended for individual patient by patient application at the time of the presentation. We expect this test to be widely used in the marketplace”.
Dr. Joseph Keffer, Chief Scientist and Managing Director of IDx commented, “We are pleased to have received this regulatory approval along with Spectral. The partnership of IDx’s research and development capabilities with Spectral’s regulatory, manufacturing, and marketing capabilities has been a powerful tool in rapidly bringing this product forward to market. We, along with Spectral, continue to develop new diagnostics targeting important emerging infectious diseases of major public health need”.
West Nile Virus infection is a mosquito borne illness that is believed to have infected tens of thousands of patients in North America since its emergence in the last several years. Many patients with West Nile Virus infection will be unaware of it or may have non-specific symptoms of fever, headache, malaise, or other flu-like symptoms that are difficult for physicians to diagnose. Current testing practices may take up to two weeks to provide clinical results. According to the U.S. Center for Disease Control, about 1 in 150 patients infected with WNV will develop a serious infection such as encephalitis or meningitis, which can result in paralysis or even death. WNV has killed nearly 100 people in North America this year with several thousand confirmed cases. It remains a growing public health concern in both Canada and the U.S.
Spectral is a developer of innovative technologies for comprehensive disease management. Spectral provides accurate and timely information to clinicians enabling the early initiation of appropriate and targeted therapy. Current products are rapid format tests measuring markers of myocardial infarction (Cardiac STATus test). New products include rapid diagnostics for sepsis (the Endotoxin Activity Assay). Spectral manufactures the EAA(TM) and Cardiac STATus. Spectral’s common shares are listed on The Toronto Stock Exchange: SDI.
This press release contains certain forward-looking statements and information based on beliefs of the Company’s senior management as well as assumptions made by, and information currently available to it. Such statements reflect the current views of the Company with respect to future events and are subject to certain risks and uncertainties. Actual results, events, and performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.
Spectral Diagnostics Inc.
CONTACT: At: Spectral Diagnostics Inc. Dr. Paul Walker Chief ExecutiveOfficer (416) 626-3233
