Single Tube, 10-Marker Panel CLL-MRD Testing by Flow Cytometry

Single Tube, 10-Marker
Panel CLL-MRD Testing by
Flow Cytometry – FAQ
1.What is chronic lymphocytic leukemia (CLL)?
CLL is a clonal expansion of B lymphocytes. The cells are derived from a small group of normal
B lymphocytes that are CD19+ and CD5+. Patients with CLL can survive from 5 to 20 years
after diagnosis.1
2. What is minimal residual disease (MRD)?
MRD means that there are a few leukemia cells remaining after a patient has been treated.
3. Why CLL-MRD test is important?
When a patient is treated so that there is less than one residual leukemia cell present among
10,000 normal white blood cells, there is very little chance that the leukemia will recur. However,
if there are more residual leukemia cells, then the disease is more likely to recur.2
4. What are the 10 markers in this test?
This panel is composed of the following markers: CD3, CD5, CD19, CD22, CD24, CD43, CD45,
CD79b, CD81, and CD160
5. Why are these 10 markers chosen for this panel?
The markers were chosen as part of the published ISA protocol on determination of MRD by
flow. CD160 is an emerging independent marker that has been shown recently to have value in
diagnosis of CLL-MRD.
6. What are the test specifications per the assay validation?
• Accuracy > 99%
• Clinical diagnostic sensitivity > 99%
• Clinical diagnostic specificity > 99%
• Analytical sensitivity: 0.01%
7.What are the sample requirements?
• Peripheral Blood: 3-10 mL in green or lavender top tube
• Bone Marrow Aspirate: 2-3 mL in green or lavender top tube
8. Could I customize the panel by adding/removing marker(s)?
Yes, Pharma Services team will work with you to develop and validate your customer panel. The
lead time will depend on each individual project needs.
9. What is the turnaround time for this test?
24 hours
10.What does the testing report look like?
The sample report can be customized but generally will have a scatter plot to show
population diversity followed by several dot plots of the relevant marker combinations
and a table with relevant statistics.
11.How much is the test?
Contact the Sales team for details (see contact information below).
12.Is there a minimum sample size requirement?
No.
13.Where do I find more information on this test?
You can visit www.neogenomics.com/Pharma-Services/Menu/Flow-Cytometry to get
more information on this test.
14.Whom do I contact if I would like to order this test?
For ordering, please call 800.720.4363, fax 713.830.6494, or email
[email protected].
References
1. Chang H-Y, Rassenti L, Salcedo M, et al. Subnetwork-based analysis of chronic lymphocytic leukemia
identifies pathways that associate with disease progression. Blood 2012; 27: 2639-49.
2. Dreger P, Dohner H, Ritgen M et al. Allogeneic stem cell transplantion provides durable disease control
in poor-risk chronic lymphocytic leukemia: long-term and MRD results of the German CLL Study Group
CLL3X trial. Blood 2010; 116:2438-47.
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