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. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule

A.M. Sets up 2 days a week.

Report Available

Reports in 10 to 14 days.

Clinical Significance

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

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.