Incorporation of Digital Gene Expression Profiling for Cell-of-Origin Determination (Lymph2Cx Testing) into the...

Area of Science:

• Hematology
• Oncology
• Molecular Diagnostics

Background:

• Diffuse Large B-cell Lymphoma (DLBCL) is a heterogeneous lymphoid malignancy.
• Morphology and immunophenotype classify DLBCL, but gene expression profiling reveals distinct molecular subgroups.
• Cell-of-origin (COO) classification (Germinal Center B-cell, Activated B-cell, Unclassified) has prognostic and therapeutic relevance.

Purpose of the Study:

• To clinically validate the Lymph2Cx digital gene expression profiling assay for COO assignment in DLBCL.
• To assess the assay's utility in routine diagnostic workflows.
• To evaluate the COO classification of DLBCL using formalin-fixed paraffin-embedded (FFPE) tissues.

Main Methods:

• Prospective analysis of 90 consecutive DLBCL cases.
• Utilized the Lymph2Cx digital gene expression profiling assay.
• Analysis performed by a CAP/CLIA-certified clinical molecular diagnostics laboratory on FFPE tissue sections.

Main Results:

• The Lymph2Cx assay demonstrated clinical validation for COO assignment in DLBCL.
• Successful application of the assay in a routine diagnostic laboratory setting.
• Analysis of 90 DLBCL cases provided prospective data on COO classification.

Conclusions:

• The Lymph2Cx assay is a validated tool for routine COO assignment in DLBCL.
• Digital gene expression profiling of FFPE tissues enables accurate molecular subtyping of DLBCL.
• This approach supports improved biological understanding and potential therapeutic stratification for DLBCL patients.