Neogenomics Laboratories

NeoGenomics News

3/13/24

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Test Updates

 

Molecular


Neo Comprehensive™ Cancer ProfilesEffective Wednesday, March 20th, the following updates will be applied to the gene content for copy number variant (CNV) detection of the Neo Comprehensive profiles for improved clinical utility.

  • Neo Comprehensive – Myeloid Disorders
    • Addition to the CNV reportable content: ABL1 and ETV6
      • ABL1 amplification (as part of BCR::ABL1) may be observed during chronic myeloid leukemia disease progression (PMID: 20417874, 30399426).
      • ETV6 copy loss is a frequent event in myeloid neoplasia.
    • Removal from the CNV reportable content: CDKN2B and STAG2
      • CDKN2B deletion will no longer be reported separately from CDKN2A deletion, given that both genes are typically deleted in combination.
      • STAG2 deletion will no longer be reported, given low incidence in myeloid neoplasia and the distinct calling criteria in XX versus XY individuals (which may not be accurately discerned by provided gender).
    • New CNV content (17 genes): ABL1, ASXL1, ATG2B, BRAF, CBFB, CDKN1B, CDKN2A, DNMT1, ETV6, EZH2, GSKIP, JAK2, KMT2A, KRAS, MYC, RAD21, TP53
  • Neo Comprehensive – Heme Cancers
    • Addition to the CNV reportable content: ATM and ETV6
      • ATM copy loss [del(11q)] is a frequent event in chronic lymphocytic leukemia and is associated with adverse outcomes.
      • ETV6 copy loss is a frequent event in myeloid neoplasia.
    • Removal from the CNV reportable content: STAG2
      • STAG2 deletion will no longer be reported, given low incidence in myeloid neoplasia and the distinct calling criteria in XX versus XY individuals (which may not be accurately discerned by provided gender)
    • New CNV content (24 genes): ABL1, ASXL1, ATM, BRAF, CBL, CD274, CDKN1B, CDKN2A, DNMT1, EPOR, ETV6, EZH2, FLT3, IKZF1, JAK2, KMT2A, KRAS, MYC, PAX5, RAD21, REL, TNFRSF14, TP53, XPO1

Pricing and CPT codes remain unchanged.

 

EGFR Mutation Analysis by PCR – This test is now NYSDOH approved and available for New York state orders!

This assay is designed to detect highly recurrent EGFR alterations in exon 18-21 (Exon 18 G719X; Exon 19 deletions; Exon 20 T790M, C797S, Exon20-Ins and S768I; Exon 21 L858R, L861Q). Activating mutations in the EGFR gene have been identified in approximately 20% of non-small cell lung cancer (NSCLC). Identifying NSCLC patients with EGFR mutation is critical in determining patient eligibility for targeted TKI therapies.  For more test details and specimen requirements, please visit the test menu page.

 

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

 

 

*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.

 

Requisition Updates

New versions of the single biomarkers solid tumor test requisitions, aligning with recent new product launches and test updates, are available for download on our website. For paper copy orders, please contact our Client Services team.

  • Single Biomarkers and Consults Solid Tumor Pathology Requisition ‒ version 021524
  • Single Biomarkers and Consults Solid Tumor Oncology Office Requisition ‒ version 021524
  • New York State Single Biomarkers and Consults Solid Tumor Pathology Requisition ‒ version 021524
  • New York State Single Biomarkers and Consults Solid Tumor Oncology Office Requisition ‒ version 02152

 

Test Discontinuations

Molecular

KRAS G12C Sponsored Testing Program - Effective Sunday, March 31st, The KRAS G12C Sponsored Testing Program (KRAS STP), offering no cost testing to help identify KRAS G12C mutation in patients with advanced non-small cell lung cancer (NSCLC), will be discontinued.

  • Orders received and accessioned between now and March 30 will process through the KRAS STP as normal.
  • Orders received and accessioned on March 31 and beyond will be put on hold while our Client Services team reaches out to inform on alternative testing options.

For any questions on the discontinuation of this program or for more information on alternative suggestions, please contact your local NeoGenomics Sales Consultant or our Client Services team at (866) 776-5907, option 3.

 

Interface Updates

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