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Description:
The
CellSearch™ Epithelial
Cell Kit is intended for
the enumeration of circulating
tumor cells (CTC) of epithelial
origin (CD45-, EpCAM+,
and cytokeratins 8,
18+, and/or 19+) in whole
blood.
The
presence of CTC in the
peripheral blood, as detected
by the CellSearch™ Epithelial
Cell Kit, is associated
with decreased progression
free survival and decreased
overall survival in
patients treated for
metastatic breast cancer.
This
test can detect the presence
of Circulating Tumor Cells
(CTC) in the peripheral
blood of metastatic breast
cancer in patients, a count
of CTC of 5 or more in 7.5
ml of blood is predictive
of shorter progression
free survival and overall
survival. Physician can
draw samples prior to a
new line of therapy for
baseline prediction; physician
can also draw samples at
the first follow up visit
for Prediction of the
therapy. The Veridex CellSearch™ System
is the only semi-automated
system designed to standardize
and optimize the measurment
of CTC in peripheral blood.
This test is also
the only FDA approved
kit for CTC detection.
Methodology:
Veridex
CellSearch™
Turnaround
Time:
4 days
Specimen Requirements:
10 mL room
temperature whole blood
collected in CellSave® Preservative
Tube; 7.5 mL minimum.
- Draw one tube per
patient.
- Collect
blood into a CellSave® Preservative
Tube only. Circulating
tumor cells (CTC) are
fragile and require preservative
for accurate analysis.
- Fill the
tube with 10 ml of blood
and immediately mix by
gently inverting the tube
eight times to prevent
clotting. Inadequate mixing
may result in inaccurate
test results.
- Ship promptly;
specimen must be tested
within 72 hours of collection.
Provide sample collection
date and time. Do not
refrigerate.
Blood samples
can be stored or transported
in CellSave® preservative
tubes for up to 72 hours
at room temperature (15
to 30 degrees c) prior
to processing.
Specimen should be submitted
Monday-Thursday only.
Draw date and time must
be provided with the whole
blood specimen.
Samples may be collected
prior to therapy and at
first follow-up visit
(4-5 weeks after initiation
of new therapy). If
patient is on doxorubicin
therapy, allow at least
7 days after administration
of a dose of therapy before
blood draw.
Rejection Criteria:
Clotted whole blood; received
refrigerated; received frozen.
Samples over 72 hours old.
CPT Code(s):
88346x2, 88361
Reference
Range:
See CTC
clinical trial data.
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