Spectral Medical IncTSX: EDT

Spectral Diagnostics and IDx receive Canadian regulatory approval for the West Nile Virus STATus Rapid Test

· Issued by Spectral Medical Inc via CNW
TORONTO, Nov. 2 /CNW/ - Spectral Diagnostics Inc. (TSX: SDI) 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.

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