LeukoVantage®, Myeloid

LeukoVantage®, Myeloid

Test Code

39194
81450
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
39194
81450
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

LeukoVantage®, Myeloid - This test is designed to aid in diagnosis, prognosis and/or treatment strategy for patients with AML, MPN and MDS.

Test Resources

Test FAQ

LeukoVantage® Myeloid Neoplasm Mutation Panels

Test Details

Includes

  • ASXL1, ATF2, ATM, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2B, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETNK1, ETV6, EZH2, FLT3, GATA1, GATA2, HRAS, IDH1, IDH2, IKZF1, JAK2, KDM6A, KIT, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PTEN, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, STAG2, STAT3, STK11, TET2, TP53, U2AF1, WT1, ZRSR2

Methodology

Next Generation Sequencing

Assay Category

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.

Reference Range(s)

See Laboratory Report

Alternative Name(s)

Myelodysplastic Syndrome (MDS),Myeloproliferative Neoplasms (MPN),Acute Myeloid Leukemia (AML)

LOINC® Codes, Performing Laboratory

Service Area must be determined
ASXL1, ATF2, ATM, BCOR, BCORL1, BRAF, CALR, CBL, CDKN2B, CEBPA, CSF3R, CUX1, DDX41, DNMT3A, ETNK1, ETV6, EZH2, FLT3, GATA1, GATA2, HRAS, IDH1, IDH2, IKZF1, JAK2, KDM6A, KIT, KRAS, MPL, NF1, NPM1, NRAS, PHF6, PTEN, PTPN11, RUNX1, SETBP1, SF3B1, SRSF2, STAG2, STAT3, STK11, TET2, TP53, U2AF1, WT1, ZRSR2

Methodology

Next Generation Sequencing
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.

Reference Range(s)

See Laboratory Report

Alternative Name(s)

Myelodysplastic Syndrome (MDS),Myeloproliferative Neoplasms (MPN),Acute Myeloid Leukemia (AML)
Service Area must be determined

Preferred Specimen(s)

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

Alternative Specimen(s)

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

Minimum Volume

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

Collection Instructions

Requisition form and Pathology/Flow Cytometry Report 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 Container

EDTA (lavender-top) tube

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
  •  
  • Fixed cell pellet
  • Room temperature: 7 days
  • Refrigerated: 7 days
  • Frozen: Unacceptable

Reject Criteria

Gross hemolysis • Clotted blood sample

Setup Schedule

Service Area must be determined
5 mL whole blood or bone marrow collected in an EDTA (lavender-top) tube
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
2 mL whole blood or bone marrow • 20 uL of 10 ng/uL extracted DNA
Requisition form and Pathology/Flow Cytometry Report 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.
EDTA (lavender-top) tube
Room temperature
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

Fixed cell pellet
Room temperature: 7 days
Refrigerated: 7 days
Frozen: Unacceptable
Gross hemolysis • Clotted blood sample
Service Area must be determined
Not offered in Quest Diagnostics Nichols Institute (IFD) – San Juan Capistrano. Please provide SERVICE AREA INFORMATION to find available tests you can order.
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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