TP53 Mutation Analysis
Use
This assay detects somatic TP53 mutations in exons 2–11. NCCN guidelines recommend TP53 mutation analysis for prognostic and therapy determination in CLL. Patients with TP53 mutations have an unfavorable prognosis and are resistant to chemoimmunotherapy. Ibrutinib is an FDA-approved BTK inhibitor that can be used for TP53 mutated CLL.
Special Instructions
Frozen bone marrow samples are NOT accepted. Extracted DNA: Isolation of nucleic acids for clinical testing must occur in a CLIA-certified laboratory or a laboratory meeting equivalent requirements. Concentration and volume must be provided for all samples.
Limitations
The assay is limited to detecting somatic TP53 mutations within exons 2–11. It does not detect mutations outside these exons or in non-coding regions. High degree of caution is needed for samples with low DNA quantity or quality, as it might affect the accuracy of the results. Proper specimen handling and storage are crucial to maintain sample stability.
Methodology
NGS (Targeted)
Biomarkers
Result Turnaround Time
14 days
Related Documents
For more information, please review the documents below
Specimen
Whole Blood
Volume
5mL
Minimum Volume
3mL
Container
EDTA preferred (NaHep accepted)
Storage Instructions
2°C to 8°C
Causes for Rejection
Improper specimen labeling; Insufficient sample volume; Clotted specimen; Specimens beyond stability; Insufficient DNA isolated
Stability Requirements
| Temperature | Period |
|---|---|
| Refrigerated | 30 Days |
| Frozen | Long Term |