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TEST:
clonoSEQ

Type:
FDA Approved
The clonoSEQ Assay is an in vitro diagnostic that uses multiplex polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged IgH (VDJ), IgH (DJ), IgK, and IgL receptor gene sequences, as well as translocated BCL1/IgH (J) and BCL2/IgH (J) sequences in DNA extracted from bone marrow from patients with B-Cell acute lymphoblastic leukemia (ALL) or multiple myeloma (MM).
Cancer:
Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Diffuse Large B Cell Lymphoma, Multiple Myeloma, Non-Hodgkin’s Lymphoma
Gene:
BCL2 (B-cell CLL/lymphoma 2), CCND1 (Cyclin D1)
Method:
Multiplex-PCR / Next-Generation Sequencing (NGS)
Approvals
Date
Cancer
Gene
Drug
By
08/05/20
FDA
Confirmatory trial(s)