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NPM1 MRD Testing by NGS
Test Code12543
CPT Codes
81310<br>This test is not available for New York patient testing<br>Restricted Client Code
Preferred Specimen
3 mL peripheral blood collected in an EDTA (lavender-top) tube
Minimum Volume
1 mL whole blood • 0.25 mL bone marrow
Other Acceptable Specimens
1 mL bone marrow collected in an EDTA (lavender-top) tube • 1 ug of previously isolated DNA submitted in a sterile transport tube
Instructions
Prefer to receive blood or bone marrow refrigerated. Room temperature specimens will need to be shipped next day.
Only send DNA under unusual circumstances.
Only send DNA under unusual circumstances.
Transport Temperature
Refrigerated (cold packs)
Specimen Stability
Whole blood and bone marrow
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable
Isolated DNA
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 14 days
Room temperature: 72 hours
Refrigerated: 7 days
Frozen: Unacceptable
Isolated DNA
Room temperature: Unacceptable
Refrigerated: 7 days
Frozen: 14 days
Methodology
Polymerase Chain Reaction
FDA Status
This test was developed and its performance characteristics determined by the Laboratory for Personalized Molecular Medicine™. It has not been cleared or approved by the U.S. Food and Drug Administration. However, such approval is not required for clinical implementation, and test results have been shown to be clinically useful.
Setup Schedule
Set up: Varies; Report available: 7-10 days
Reference Range
Not detected
Clinical Significance
LabPMM's NPM1 MRD test is a NGS-based, targeted, deep-sequencing assay that can be used to detect NPM1 mutations that were previously identified in a primary sample.
To identify and track previously detected NPM1 mutations in post-treatment follow-up samples, a multiplex master mix targeting exon 12 on the NPM1 gene is used to amplify DNA extracted from a patient sample. PCR products are sequenced to identify DNA sequences specific to previously identified mutations detected at diagnosis. Bioinformatics tools are used to reliably detect specific sequences present at an allelic sensitivity level of 5 x 10-5.
- Identify tumor-specific markers for post-treatment monitoring
- Monitor and evaluate disease recurrence
To identify and track previously detected NPM1 mutations in post-treatment follow-up samples, a multiplex master mix targeting exon 12 on the NPM1 gene is used to amplify DNA extracted from a patient sample. PCR products are sequenced to identify DNA sequences specific to previously identified mutations detected at diagnosis. Bioinformatics tools are used to reliably detect specific sequences present at an allelic sensitivity level of 5 x 10-5.
- Identify tumor-specific markers for post-treatment monitoring
- Monitor and evaluate disease recurrence
