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The
ability to rapidly and accurately make a definitive diagnosis
remains one of the biggest challenges faced by healthcare
professionals today.
Spectral is dedicated to the accelerated development and
commercialization of innovative diagnostic solutions that
will improve patient management. Our goals are to provide
our customers with unique diagnostic products that will
enable them to more rapidly and accurately diagnose their
patients, enabling improved outcomes and better utilization
of health care resources.
Competitive Advantage
Spectral
possesses a breadth of experience in both the clinical
diagnostic setting and the laboratory environment. Our
competitive advantage is built upon the ability to identify
a clinical need and provide rapid and reliable solutions.
Spectral's
product development cycle includes R & D activities, clinical investigation
and validation studies led by an experienced in-house team of
protein chemists, molecular biologists, immunologists and clinical scientists.
Products
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The EAA™
Endotoxin Activity Assay
is the first FDA approved diagnostic test in the
field of sepsis. Endotoxin is an important biomarker for the
rapid identification of patients at risk for sepsis. With
the ability to provide this unique diagnostic information
within an hour, Spectral’s EAA™ continues to expand its
International customer base, supported by its Toronto,
Canada manufacturing facility.
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The
RapidWN™
West
Nile Virus IgM Test
is another of Spectral’s innovative products designed to
meet the continually changing needs in the world of
healthcare. With its flu-like symptoms, the West Nile virus
is a rapidly growing healthcare concern, reaching epidemic
proportions in some locations. Armed with this unique and
rapid assay, physicians can quickly obtain diagnostic
information regarding exposure to this potentially deadly
virus.
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Spectral
continues its history of developing high quality, high
performance monoclonal antibodies and
recombinant proteins. These proprietary reagents are
sought after by highly reputable and specialized research
groups and commercial organizations worldwide. |
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Commitment to Quality
Spectral
has a strong commitment to quality and following The Medical
Device Regulations under CMDCAS as mandated by Health
Canada, Spectral Diagnostics has received and continues to
operate its development and manufacturing facility under
cGMP (US 21 CFR Part 820), IS0-9001: 2000 and CAN/CSA
ISO-13485-2003 certifications.
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