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Test Code LAB9778 Hematologic Molecular Algorithm

Performing Laboratory

Barnes-Jewish Hospital Molecular Diagnostic Laboratory

Methodology

All orders submitted to the MDL for inpatient and outpatient hematologic malignancy testing are assessed for appropriateness based on correlation with new and existing clinical data. This approval process applies only to bone marrow aspirates and peripheral blood specimens and only to the specific molecular diagnostic orders detailed within this document. The laboratory medicine resident or fellow (LMR) will be responsible for the triaging of orders with oversight from the Medical Director. 

Test Classification and CPT Coding

Varies by testing ordered.

Additional Information

  • Orders for the Hematologic Molecular Algorithm (HMA) requires that FISH, HemePath, and MRD by flow be signed out prior to action by the MDL. In cases where sample processing would be delayed beyond stability requirements, testing will be sent but may be canceled if later deemed inappropriate based on clinicopathologic data.
  • All testing will be prioritized on the bone marrow aspirate if duplicate orders submitted with peripheral blood whether ordered as part of the HMA or not.
  • If specific testing is required outside of the HMA indications below, please submit a separate order and the LMR and/or MDL will evaluate for approval. Justifications can preemptively be directed to BJH-MDL@email.wustl.edu. Keep in mind, the LMR or MDL cannot place orders in EPIC or cancel orders without written approval from the clinical team. However, a request for the HMA gives the LMR and MDL the greatest flexibility to manage testing.

Purpose

To document the expectations of test selection and approval by the Molecular Diagnostics Lab (MDL) at Barnes-Jewish Hospital.

Testing Algorithm

See HMA Algorithm

Summary of Hematologic Molecular Algorithm (HMA) approvals for both inpatients and outpatients:

  1. MyeloSeq and Chromoseq will be ordered in
    1. New AML Diagnosis
    2. Prior AML Diagnosis
      1. With active disease (blasts > 10%) and no prior genetic panel testing or
      2. With relapse
    3. New MDS Diagnosis
    4. New blast phase of CML (requires myeloid blasts)- MyeloSeq only, no ChromoSeq
  2. FLT3-ITD/TKD will be ordered in
    1. New Diagnosis of AML
    2. New Relapse of AML 
    3. NOTE: FLT3 is not recommended for monitoring MRD as sensitivity is near 5%.
  3. BCR/ABL p210 quantitative PCR will be ordered in
    1. Monitoring of prior p210-positive leukemia
    2. New BCR/ABL FISH positive disease (with reflex to p190 if negative)

    3. Note: Specific (non-HMA) BCR/ABL p210 orders will not be switched to p190 orders by the lab without approval from the treating team.

  4. BCR/ABL p190 quantitative PCR will be ordered in
    1. Monitoring of prior p190-positive leukemia
    2. New BCR/ABL FISH positive disease (with negative p210)
    3. Note: Specific (non-HMA) BCR/ABL p190 orders will not be switched to p210 orders by the lab without approval from the treating team.
  5. Rearrangement-specific quantitative PCR (currently limited to PML/RARA, CBFB/MYH11, RUNX1/RUNX1T1) will be ordered in
    1. Monitoring of prior PCR-positive leukemia
    2. New FISH-positive disease with indicated rearrangements
  6. Nationwide Children’s Hematologic Cancer Fusion Analysis (Archer Dx) will be ordered from peripheral blood (preferred) or bone marrow aspirate in
    1. New Philadelphia-Negative B-Cell leukemia with >10% blasts
      1. Additionally requires normal cytogenetics:
        1. Lack of hyper- or hypodiploidy
        2. Lack of CRLF2 or KMT2A rearrangements
  7. Tempus xT gene panel (currently 648 genes) will be ordered in lymphoid leukemias without hyper- or hypodiploidy or FISH rearrangements in BCR/ABL or KMT2A in cases of a
    1. New diagnosis of B/T-Cell Leukemia
    2. Relapse of B/T-Cell Leukemia (only with active disease (blasts > 10%) and no prior panel testing)
  8. IGHV hypermutation by NGS (in-house) and TP53 sequencing (sent to Mayo) will be ordered in
    1. New diagnosis of CLL only
    2. Prior CLL diagnosis with no prior testing history

Please see attached HMA ordering flowchart for a graphical summary of this document.