A B C D E F G H I J K L M N O P Q R S T U V W X Y Z #

LeukoVantage®, Acute Myeloid Leukemia (AML)

Test Code
36787


CPT Codes
81450

Includes
ASXL1, ATM, BCOR, BCORL1, CBL, CDKN2B, CEBPA, CREBP(ATF2), CSF3R, DDX41, DNMT3A, ETV6, EZH2, FLT3, GATA1, GATA2, IDH1, IDH2, IKZF1, JAK2, KDM6A, KIT, KRAS, MLL (PTD only), MPL, NF1, NPM1, NRAS, PHF6, PTEN, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, STAG2, STK11, TET2, TP53, U2AF1, WT1, ZRSR2 genes


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


Minimum Volume
2 mL whole blood or bone marrow • 20 uL of 10 ng/uL DNA


Other Acceptable Specimens
Whole blood or bone marrow collected in: Sodium heparin (green-top) tube • 50 uL of 10 ng/uL extracted DNA in microcentrifuge tube


Instructions
Requisition form and Pathology/Flow Cytometry Reports are required. 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.


Transport Temperature
Room temperature


Specimen Stability
Whole blood or bone marrow (EDTA)
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

Whole blood or bone marrow (Sodium heparin)
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

Extracted DNA
Room temperature: 30 days
Refrigerated: 2 years
Frozen: Indefinite


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


Methodology
Next Generation Sequencing • Long Range Polymerase Chain Reaction

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics Nichols Institute. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Tuesday, Thursday Morning Report available: 11 Days


Reference Range
See Laboratory Report


Clinical Significance
This test is designed to aid in diagnosis and/or treatment strategy for patients with AML.


Performing Laboratory
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042




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.