CEBPA by PCR

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.

CEBPA biallelic mutations have been used as indicator for risk stratification on prognosis for cytogenetically normal acute myeloid leukemia (CN-AML).

This test detects deletion or duplication mutations in the CCAAT/enhancer-binding protein alpha (CEBPA) gene on chromosome 19 (q13.11) in patients with clinical symptoms associated with AML. AML with mutated CEBPA gene is a diagnostic category in the current WHO classification of hematopoietic neoplasms. CEBPA mutation on both alleles (so-called double mutation status) is considered a good prognostic feature in adults with newly diagnosed AML whom have a normal karyotype or do not contain an alternate diagnostic genetic abnormality.

Copy of the referring client's requisition form to accompany specimen.

Refrigerated: 5 days; ambient (room temperature): 3 days; specimen must be received by laboratory within 7-days of collection.

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.