MPN Diagnostic Reflex Panel (JAK2→CALR/MPL)
Test Summary
The Myeloproliferative Neoplasm (MPN) Reflex Panel is a targeted Next-Generation Sequencing (NGS) assay designed for the molecular evaluation of patients with clinical or laboratory features suggestive of Philadelphia chromosome-negative MPNs. The test detects pathogenic and likely pathogenic variants in JAK2 (exons 12 & 14), CALR (exon 9), and MPL (exon 10) using a tiered reflex workflow.
Initial analysis includes JAk2 V617F and Jak2 exon 12 variants. If no JAK2 mutation is identified, the assay reflexes to CALR and MPL mutation analysis. Detection of these driver mutations supports diagnosis, classification and clinical management of polycythemia vera (PV), essential thrombocythemia (ET), primary myelofibrosis (PMF), and other Philadelphia chromosome-negative MPNs. Identification of JAK2 exon 12 variants is particularly useful in evaluating V617F-negative cases.
This assay is intended for patients undergoing evaluation for suspected MPNs. It is not designed for minimal residual disease monitoring or for screening asymptomatic individuals.
Aliases
MPNRef
Specimen Collection
Special Instructions
Preferred Specimen
Peripheral whole blood
Bone Marrow
Extracted genomic DNA obtained in a CLIA-certified, CAP accredited clinical laboratory meeting assay quality and quantity requirements.
Minimum Volume
Peripheral whole blood: 1 mL
Bone Marrow: 1 mL
Extracted genomic DNA: ≥ 50 ng total DNA (at ≥ 2 ng/µL)
Instructions
- Collect peripheral whole blood or bone marrow aspirate in EDTA (lavender) tube.
- Gently invert tube 5 times; DO NOT SHAKE
Patient Preparation
N/A
Storage
Lavender tube
Transport Temperature
Room Temperature
Specimen Stability
Whole Blood: Refrigerated = 7 days
Bone Marrow: Refrigerated = 7 days
Extracted genomic DNA: Refrigerated = 14 days, Freezer = long term if not repeatedly thawed.
Limitations
The assay detects somatic variants within the targeted regions of JAK2, CALR, and MPL only: mutations outside these regions will not be identified. Variants present below the validated limit of detection (5% VAF) may not be reliably detected. This test is not intended for minimal residual (MRD) monitoring or for screening asymptomatic individuals.
Other Acceptable Specimens
Additional specimen types may be considered if validated and meeting minimum DNA quality standards.
Unacceptable Specimens
Clotted, hemolyzed blood or bone marrow
Non-EDTA tubes
Frozen blood or bone marrow
Order Code
EPIC (Premier) Code
LAB7005
Includes
N/A
CPT Code
81270
Billing Code
300150
CPT Statement
Methodology
Next Generation Sequencing Based Assay
FDA Status
Not FDA Approved
Physician Attestation of Informed Consent
N/A
Testing Laboratory
2308 Sandridge Drive
Moraine OH, 45439
Department
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Thursday; Report available: 5 -7 days
Specimen Collection
Special Instructions
Preferred Specimen
Peripheral whole blood
Bone Marrow
Extracted genomic DNA obtained in a CLIA-certified, CAP accredited clinical laboratory meeting assay quality and quantity requirements.
Minimum Volume
Peripheral whole blood: 1 mL
Bone Marrow: 1 mL
Extracted genomic DNA: ≥ 50 ng total DNA (at ≥ 2 ng/µL)
Instructions
- Collect peripheral whole blood or bone marrow aspirate in EDTA (lavender) tube.
- Gently invert tube 5 times; DO NOT SHAKE
Patient Preparation
N/A
Storage
Lavender tube
Transport Temperature
Room Temperature
Specimen Stability
Whole Blood: Refrigerated = 7 days
Bone Marrow: Refrigerated = 7 days
Extracted genomic DNA: Refrigerated = 14 days, Freezer = long term if not repeatedly thawed.
Limitations
The assay detects somatic variants within the targeted regions of JAK2, CALR, and MPL only: mutations outside these regions will not be identified. Variants present below the validated limit of detection (5% VAF) may not be reliably detected. This test is not intended for minimal residual (MRD) monitoring or for screening asymptomatic individuals.
Other Acceptable Specimens
Additional specimen types may be considered if validated and meeting minimum DNA quality standards.
Unacceptable Specimens
Clotted, hemolyzed blood or bone marrow
Non-EDTA tubes
Frozen blood or bone marrow
Result Information
Methodology
Next Generation Sequencing Based Assay
Testing Laboratory
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Monday, Thursday; Report available: 5 -7 days