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

Study Overview
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Brief Summary
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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.

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

Conditions
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B-Cell Lymphoproliferative Disorder

Intervention / Treatment
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* Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DNA extracted from Peripheral Blood (PB) with EDTA as anticoagulant with minimum total DNA ≥ 2 µg with concentration at ≥ 50ng/µl DNA extracted from PB specimens no more than 7 days DNA stored at -15°C to -30°C up to 5 years Donor Age: ≥ 18 For positive sample, DNA from PB of subjects diagnosed (at the time the specimen was drawn) with Lymphoproliferative disease, with: ICD 10 Codes: C8300, C8330, C8510 or other B-cell leukemia/lymphoma diagnosis B-cell Lymphoproliferative disease diagnosis per collection site procedure (i.e. SNOMED) For negative sample, DNA from PB of subjects suspected of Lymphoproliferative disease Exclusion Criteria: 1. PB specimens that have been frozen prior to extraction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| B-Cell Positive Lymphoproliferative Disorders<br>DNA Samples for subjects with B-Cell Positive Lymphoproliferative Disorders | Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay<br>* The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease<br>|
| B-Cell Negative Lymphoproliferative Disorders<br>DNA Samples for subjects suspected of B-Cell Positive Lymphoproliferative Disorders with negative B-Cell Clonality testing | Diagnostic Test: IdentiClone Dx IGH (IC IGH Dx) Assay<br>* The IdentiClone Dx IGH Assay is an in vitro diagnostic product intended for qualitative, capillary electrophoresis based-detection of clonality in immunoglobulin heavy chain gene rearrangements (IGH) in peripheral blood specimens as an adjunctive method for the diagnosis of B-cell lymphoproliferative disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Agreement | Agreement between the results of the Invivoscribe IdentiClone Dx IGH Assay and the LymphoTrack Dx IGH (FR1/FR2/FR3) Assays - MiSeq by assessing the positive and negative percent agreement between the two assays. | Through Study Completion at one year |