Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx TRG Assay

Inclusion Criteria

• •1. De-identified, residual FFPE specimens with a minimum of 8 curls
• •2. Subject Age ≥ 18
• •3. For suspected clonal positive specimens, FFPE specimens of subjects diagnosed (at the time the specimen was drawn) with T-cell Lymphoproliferative disease with at least one of the following:
• •1. ICD10 Codes: C84, C85.8, C85.9, C86.1, C86.2, C86.3, C86.5, 86.6, C91.5, C91.6, C91.0, C91.z, C91.9, C94, C95, C96, or other T-cell lymphoma diagnosis
• •2. b. T-cell lymphoproliferative disease diagnosis per collection site procedure (e.g., SNOMED)
• •3. Mycosis fungoides or Sézary syndrome sample are acceptable
• •4. For suspected clonal negative specimens, FFPE specimens of subjects suspected of T-cell lymphoproliferative disease but diagnosed negative for T-cell lymphoproliferative disease. Up to 20% of the negative specimens may be from normal tissue or tissue diagnosed with diseases other than T-cell lymphoproliferative disease