NeoGenomics News

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2/28/2024

Test Updates

Early-stage NSCLC Panel

Effective Monday, March 4th, the Early-stage NSCLC Panel will now be offered with an opt-out for PD-L1 (22C3). This will add flexibility in the ordering of the panel for those who perform PD-L1 testing in-house or have already ordered PD-L1 testing.

The following changes will be implemented for this test:

  • CPT codes: If opt-out is selected, 88360x1 will be removed
  • No changes to TAT
  • New York state clients: This test is actively undergoing submission for NYS approval. Stay tuned for updates on availability
  • Ordering: Online Orders will be updated with the new opt-out option on the effective date. The update will be available on test requisitions in the next revision coming soon
  • Interfaced clients: Please refer them to the interface section of NeoNEWS for additional details
 

FISH

Effective Monday, March 4th, the following updates will be applied to the lymphoma FISH panels to align with the WHO 5th Edition Classification and to provide more comprehensive prognostic information for large B-cell lymphomas.

  • High-Grade/Large B-Cell Lymphoma FISH Panel
    • MYC/IgH/CEN8 t(8;14) will be added to the panel permanently. It will no longer be an optional add-on.
      • Future panel configuration: BCL2 (18q21) | BCL6 (3q27) | MYC (8q24) | MYC/IgH/CEN8 t(8;14)
    • An optional reflex will be available
      • Reflex to IGK/MYC t(2;8), IGL/MYC t(8;22), and BCL6/MYC t(3;8) if MYC (8q24) is positive and MYC/IgH/CEN8 t(8;14) is negative
    • Reflex results will be integrated into the final report of the panel
  • High-Grade B-Cell Lymphoma Reflex FISH Panel
    • MYC/IgH/CEN8 t(8;14) will be added to the initial panel
      • Future panel configuration: MYC (8q24) | MYC/IgH/CEN8 t(8;14)
    • Reflex scheme will proceed as follows
      • Reflex to BCL2 (18q21) and BCL6 (3q27) if MYC/IgH/CEN8 t(8;14) is positive OR
      • Reflex to BCL2 (18q21), BCL6 (3q27), IGK/MYC t(2;8), IGL/MYC t(8;22), and BCL6/MYC t(3;8) if MYC (8q24) is positive and MYC/IgH/CEN8 t(8;14) is negative
    • All results will be integrated in one report.

FISH Signal Guide will be updated and available for download on NeoLINK under Documentation on March 4.

 

Molecular

PML-RARA Translocation, t(15;17) – This test is now NYSDOH approved and available for New York state orders!

It is a real-time RT-PCR assay for quantitative detection of both long and short isoforms of the t(15;17) PML-RARA fusion transcript. Identification of these fusion transcripts is essential in acute promyelocytic leukemia (APL) because it is closely correlated with responsiveness to treatment with all-trans retinoic acid (ATRA) or other specific therapy which substantially improves survival of patients with the disease. Presence of this abnormality in acute myeloid leukemia (AML) is associated with excellent outcome.

Specimen Requirements include:

  • Bone marrow (preferred): 2 mL in EDTA tube
  • Peripheral blood (acceptable): 5 mL in EDTA tube
 

BRAF Mutation Analysis

Effective as of Monday, February 26th, BRAF Mutation Analysis is now performed by real-time PCR instead of bi-directional Sanger sequencing. Shifting from Sanger to PCR increases test sensitivity and creates operational workflow efficiencies, allowing for continued focus on improving patient care. The following changes have been implemented for this test:

 
New Test NameBRAF Mutation Analysis by PCR
Old (Discontinued) Test NameBRAF Mutation Analysis
  • Test Name Change to: BRAF Mutation Analysis by PCR
  • Test Information: This test is designed to detect V600 mutations E, K, D, R and G performed by real-time PCR instead of bi-directional Sanger sequencing
  • No changes: to CPT codes or TAT (7 days)
  • Specimen Requirements: Fine Needle Aspirates (FNAs) are no longer an acceptable specimen type for this test. All other specimen requirements remain unchanged.
  • Ordering: Online Orders will be updated with the new test name on the effective date. There is no change to the ordering name on test requisitions
  • New York State Clients: This test is actively undergoing submission for NYS approval. NYS Clients will continue to be able to order the Sanger based test until the new PCR test is approved. Stay tuned to NeoNEWS for continued updates on availability
  • Interfaced clients: Please refer to the interface section of NeoNEWS for additional details
 

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

 

Interface Updates

For a complete list of interface-related test changes, click here for a downloadable document to view the impacted interface test codes.