LeukoVantage®, Myelodysplastic Syndrome (MDS)

Test Code

36789

CPT Codes
81450

Includes

ASXL1, ATM, BCOR, CBL, CEBPA, CSF3R, CUX1, DNMT3A, ETNK1, ETV6, EZH2, FLT3, GATA2, IDH1, IDH2, IKZF1, JAK2, KRAS, NF1, NPM1, NRAS, PHF6, PTEN, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, STAG2, STAT3, 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 extracted 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 • Fixed pellet collected in a sterile leak-proof container

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 and bone marrow (EDTA)
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable

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

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

Celle pellet
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable

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

Gross hemolysis • Frozen • Clotted

Methodology
Next Generation Sequencing

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

Tuesday, Thursday Morning Report available: 11 Days

Reference Range

See Laboratory Report

Clinical Significance

This test is designed to aid in diagnosis, prognosis and/or treatment strategy for patients with MDS

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.