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

CompletedOBSERVATIONAL
Enrollment

250

Participants

Timeline

Start Date

January 2, 2024

Primary Completion Date

November 6, 2024

Study Completion Date

November 6, 2024

Conditions
B-Cell Lymphoproliferative Disorder
Interventions
DIAGNOSTIC_TEST

IdentiClone Dx IGH (IC IGH Dx) Assay

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

Trial Locations (3)

85399

LabPMM GmbH, Hallbergmoos

92103

Invivoscribe, Inc., San Diego

210-0821

LabPMM GK, Kawasaki-shi

All Listed Sponsors
lead

Invivoscribe, Inc.

INDUSTRY

NCT06112301 - Pivotal, Clinical Study for the Accuracy Evaluation of the IdentiClone Dx IGH Assay | Biotech Hunter | Biotech Hunter