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April 2, 2025

Molecular

Effective Monday, April 7th, the following NGS panels will be updated with additional biomarkers, as specified below, to enhance their clinical utility and to better align with current guidelines. This update will be applicable to both new and in-flight cases.

• NeoTYPE^® MDS/CMML Profile
  • Gene(s) to be added: CSF3R
  • Clinical Significance: CSF3R mutations, especially the T618I mutation, are identified in chronic neutrophilic leukemia and other myeloid neoplasms with proliferative features.
• Neo Comprehensive^® – Myeloid Disorders
  • Gene(s) to be added: PRPF8
  • Clinical Significance: PRPF8 mutations contribute to adverse prognosis in the molecular international prognostic scoring system (IPSS-M) for myelodysplastic syndrome (doi: 10.1056/EVIDoa2200008).
• NeoTYPE^® ALL Profile and NeoTYPE^® ALL Profile for New York
  • Gene(s) to be added:
    • DNA Sequencing (SNVs/InDels): FBXW7, IDH1, IDH2, KRAS, NOTCH1, NRAS, PAX5, PHF6
    • RNA Sequencing (Fusions): BCL11B, MYB, NUP214, STIL
  • Clinical Significance: The addition of these genes to the NeoTYPE ALL Profile expands the panel’s coverage to include additional relevant biomarkers in both B-ALL and T-ALL to aid in diagnosis and subclassification, predicting prognosis, and guiding therapeutic management.

CPT Codes, pricing, and NYS approvals remain the same. Test webpages will be updated on April 7 with the additional genes.

 

To serve our customers and their patients, we evaluate our test menu regularly to align with clinical guidelines. Effective May 12th, we will improve our test offerings to serve your diagnostic needs. While specific tests will be discontinued, we have thoroughly evaluated and identified more appropriate tests from our menu that align with recommended guidelines. Below is a comprehensive list of affected tests and their recommended replacements.

Orders for the NeoTYPE^® Discovery Profile and replaced tests will not be automatically converted. Please order the new test using the appropriate requisition form or the online ordering portal to avoid testing delays.

For a complete list of test updates, click here.