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Associates of Cape
Cod, Inc. (ACC)
has launched a new
clinical diagnostics
division focusing
on (1,3)-ß-D-glucan
analysis to aid
in the diagnosis
of Invasive Fungal
Infections (IFI).
In 2004, ACC
began the manufacture
and sale of the
Fungitell®
assay, a diagnostic
kit for the detection
of (1,3)-ß-D-glucan
in serum. ACC
also owns and
operates a CLIA-certified
reference laboratory
called Beacon
Diagnostics
Laboratory that
specializes in
serum (1,3)-ß-D-glucan
testing.
Immune suppressed
patients are at
high risk for
developing invasive
fungal infections,
which are typically
difficult to isolate
and diagnose.
Affected patient
populations include:
1. Cancer patients
undergoing chemotherapy
2. Stem Cell and
Organ Transplant
patients
3. Burn patients
4. HIV patients
5. ICU patients
The Fungitell
kit:
- Is
510(k) cleared
by the FDA for
diagnostic use
- Is
indicated for
use as an aid
in the diagnosis
of Invasive
Fungal Infections
(IFI).
- Is
nearly panfungal
- the test will
detect most
medically important
fungi including
Aspergillus
and Candida.
The kit does
not detect Zygomycetes
and has limited
detection of
Cryptococcus
due to the absence
or low levels
of (1,3)-ß-D-glucan
in these fungi.
- Contains
enough reagents
to run 24 to
42 patient samples
(depends of
number of replicates)
- Requires
only an incubating
microplate reader
and standard
software to
run
- Has
a run time of
40 minutes
- Is
sensitive to
picogram levels
Originally
marketed as the
Glucatell®
kit, the Fungitell
kit has its origins
in the research
product line of
the same name.
Beacon
Diagnostics Laboratory,
our fungal diagnostic
testing service,
is a CLIA-certified
reference laboratory
specializing in
serum (1,3)-ß-D-glucan
analysis. Beacon
Diagnostics laboratory
serves the clinical
community's need
for improved methods
for the diagnosis
of invasive fungal
infection.
In the future,
ACC will be adding
new diagnostic
kits and laboratory
tests to its line
of products and
services. These
products will
be offered through
ACC and its services
provided through
Beacon Diagnostics
Laboratory.
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