Myeloproliferative Neoplasms (MPN) Mini Panel

Test Code
13221


CPT Codes
81219, 81270, 81338, 81279

Includes
JAK2 Variant (V617F, Exon 12, Exon 13, Exon 14)
MPL Variant
CALR Variant


Preferred Specimen
5 mL whole blood or 3 mL bone marrow collected in an EDTA (lavender-top) tube


Minimum Volume
3 mL whole blood • 1 mL bone marrow


Other Acceptable Specimens
Whole blood or bone marrow collected in: Sodium heparin (green-top) tube


Instructions
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.

Because of the critical nature of these specimens, the laboratory will attempt to process all specimens received, regardless of age of specimen.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 48 hours
Refrigerated: 15 days
Frozen: Unacceptable


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Clotted • Gross hemolysis


Methodology
Next Generation Sequencing

FDA Status
This test was developed and its performance characteristics determined by MedFusion. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.

Setup Schedule
Set up: Sun, Tues, Thurs; Report available: 8-10 days


Reference Range
JAK2 VariantNot detected
MPL VariantNot detected
CALR VariantNot detected


Clinical Significance
The mpn mini profile detects disease-defining, potentially targetable mutations in jak2, calr, and mpl for myeloproliferative neoplasms. These 3 genes are growth-promoting oncogenes that operate through a signaling pathway mediated by jak2, and mpns with these mutations can respond to clinically available jak2 inhibitors. The inclusion of hot spot mutation testing in these 3 genes into the routine workup of mpns is recommended by the world health organization's classifications of hematological malignancies and the national comprehensive cancer network (nccn) guidelines. This combined testing method provides diagnostic assistance, provides a clonal molecular marker of disease following diagnosis and post therapy follow-up, influences prognosis, and identifies those mpns that may potentially benefit from jak2 inhibitor therapy.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.