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Myeloproliferative Neoplasms (MPN) Core Diagnostic Panel
Test Code13010
CPT Codes
81270, 81279, 81219, 81339
Preferred Specimen
4 mL whole blood or 3 mL bone marrow aspirate collected in an EDTA (lavender-top) tube
Minimum Volume
3 mL whole blood • 1 mL bone marrow aspirate
Other Acceptable Specimens
Whole blood or bone marrow aspirate collected in: Sodium heparin (green-top) tube • Fixed cell pellet collected in a plastic leak-proof container • Extracted DNA from CLIA-certified laboratory collected in a sterile leak-proof container
Instructions
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Extracted DNA: In addition, only accept extracted DNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or CMS.
Cell Pellets: Send fixed samples within 7 days of fixation date in a plastic, leak-proof tube/container. Indicate type of fixative used along with patient name, specimen source, date collected, and date harvested/fixed. Cell pellets submitted in Carnoy's or other alcohol-based fixatives are acceptable.
Extracted DNA: In addition, only accept extracted DNA when extraction or isolation is performed in an appropriately qualified laboratory such as a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the CAP and/or CMS.
Cell Pellets: Send fixed samples within 7 days of fixation date in a plastic, leak-proof tube/container. Indicate type of fixative used along with patient name, specimen source, date collected, and date harvested/fixed. Cell pellets submitted in Carnoy's or other alcohol-based fixatives are acceptable.
Transport Temperature
Whole blood and bone marrow: Room temperature
Cell pellet and DNA: Frozen
Cell pellet and DNA: Frozen
Specimen Stability
Whole blood and bone marrow aspirate
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Cell pellet and extracted DNA
Room temperature: Unacceptable
Refrigerated: Acceptable
Frozen: Preferred
Room temperature: Preferred
Refrigerated: Acceptable
Frozen: Unacceptable
Cell pellet and extracted DNA
Room temperature: Unacceptable
Refrigerated: Acceptable
Frozen: Preferred
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Hemolysis
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 5-7 days
Reference Range
| JAK2 V617F Mutation | Not detected |
| JAK2 Exon 12 Mutation | Not detected |
| CALR Exon 9 Mutation | Not detected |
| MPL Exon 10 Mutation | Not detected |
Clinical Significance
The MPN Core Diagnostic panel is an evidence-based, disease targeted mutational analysis panel, performed by Next-generation sequencing (NGS). Testing for disease-defining driver mutations in JAK2 V617F, JAK2 exon 12, CALR, and MPL, as part of the early evaluation for BCR-ABL1-negative myeloproliferative neoplasms (MPNs) including polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), assists with diagnosis; is supported by medical guidelines; should be performed using highly sensitive molecular methods; and also impacts prognosis and therapy selection. The panel tests nucleic acid harvested from leukocytes from blood or bone marrow specimens.
This panel does NOT include testing for the BCR-ABL1 rearrangement, which can be detected using BCR-ABL1 Gene Rearrangement, Quantitative, PCR or FISH, CML/ALL, BCR/ABL Translocation 9;22. MPN patients who are found to be pan-negative (~10% of cases) on the MPN Core Diagnostic panel may be candidates for CSF3R Mutation Analysis or Quest?s LeukoVantage®, Myeloproliferative Neoplasms (MPN), which offers an expanded panel of gene targets supported by medical literature. Results of this assay should be correlated with morphology and other clinical and laboratory findings for definitive diagnosis and classification.
This panel does NOT include testing for the BCR-ABL1 rearrangement, which can be detected using BCR-ABL1 Gene Rearrangement, Quantitative, PCR or FISH, CML/ALL, BCR/ABL Translocation 9;22. MPN patients who are found to be pan-negative (~10% of cases) on the MPN Core Diagnostic panel may be candidates for CSF3R Mutation Analysis or Quest?s LeukoVantage®, Myeloproliferative Neoplasms (MPN), which offers an expanded panel of gene targets supported by medical literature. Results of this assay should be correlated with morphology and other clinical and laboratory findings for definitive diagnosis and classification.
