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

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

This protocol describes the pivotal accuracy study for the IdentiClone Dx IGH (IC IGH Dx) Assay. The intent of the accuracy study is to demonstrate agreement between the results of the IC IGH Dx Assay and a predicate devise or assay on retrospective and residual de-identified DNA extracted from peripheral blood (PB) samples from individuals with suspected B-Cell Lymphoproliferations. The predicate device will be the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq (LT Dx IGH-CE-IVD), which is a CE-IVD assay with a similar intended use as the IC IGH Assay on the same sample type.

Inclusion Criteria:

1. DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl

2. DNA extracted from PB specimens no more than 7 days

3. DNA stored at -15°C to -30°C up to 5 years

4. Donor Age: ≥ 18

5. For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with:

   1. ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis
   2. B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED)

6. For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease

Exclusion Criteria:

1. PB specimens that have been frozen prior to extraction