- Tech Only CPT 81219
- Tech Pro CPT
- PowerPath Code CALR ex9in
- Schedule Monday to Friday (Variable)
- Turn Around Time 4-7 days
- Disease State Myeloproliferative Neoplasms
- Methodology PCR, Polymerase Chain Reaction (PCR)-based fragmentation anaylsis of exon 9 in the CALR gene by capillary electrophoresis
Minimum of 3 mL whole blood in a purple (EDTA) or pink top tube (EDTA); minimum of 1 mL of bone marrow aspirate in a purple, pink, or green (heparin) top tube.
Somatic mutations in CALR gene, which encodes endoplasmic reticulum chaperone Calreticulin, were found in majority of patients with Myeloproliferative neoplasms without JAK2 mutation. Insertions or deletions in exon 9 of CALR were detected in 67% of patients with essential thrombocythemia (ET) and 88% of those with primary myelofibrosis (PMF), but rarely detected in patients with polycythemia vera. This assay was designed to detect all types of insertions and deletions in exon 9 of CALR that has been reported.
Required Patient Info
Copy of the referring client's requisition form to accompany specimen.
Storage and Transportation
Refrigerated: 5 days; ambient (room temperature): 3 days; specimen must be received by laboratory within 7-days of collection.
Cause for Rejection
Frozen specimen; clotted or grossly hemolyzed specimens; serum; specimens without 2 patient identifiers; serum or plasma, aliquots (previously open containers); specimen that were received >7-days after collection.
2 years DNA and raw data; whole blood and bone marrow - 1 week.
This test was developed and its performance characteristics determined by CellNetix Labs LLC. The U.S. Food and Drug Administration (FDA) has not approved or cleared this test. However, FDA approval or clearance is currently not required for clinical use of this test. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions. CellNetix is authorized under Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.