clonoSEQ Kit Test

Overview

  • EPIC Code:
  • Soft Test Code:
  • CLONO
Clinical Significance

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 BCL 1/IgH (J) and BCL 2/IgH (J) sequences in DNA extracted from bone marrow from patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma (MM), and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL).  The clonoSEQ Assay measures minimal residual disease (MRD) to monitor changes in burden of disease during and after treatment.  The test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making and in conjunction with other clinicopathological features.


Specimen Collection & Preparation

Specimen Requirements

2.0 mL Whole Blood or 1.0 mL Bone Marrow in the Lavendar Top Tube (Provided in Kit)

Alternate Specimen

 

TransportAndStorage

Specimens stable withing the clonoSEQ shipper for ambient, summer and winter shipping conditions: up to 4 days for BMA, up to 5 days for whole blood

Collection Instructions

 

Clinical Interpretation

Methodology:
  • Polymerase Chain Reaction (PCR)

Clinical Significance

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 BCL 1/IgH (J) and BCL 2/IgH (J) sequences in DNA extracted from bone marrow from patients with B-cell acute lymphoblastic leukemia (ALL) or multiple myeloma (MM), and blood or bone marrow from patients with chronic lymphocytic leukemia (CLL).  The clonoSEQ Assay measures minimal residual disease (MRD) to monitor changes in burden of disease during and after treatment.  The test is indicated for use by qualified healthcare professionals in accordance with professional guidelines for clinical decision-making and in conjunction with other clinicopathological features.


Production Schedule

Turn Around Time

Id clonality takes 2 weeks, MRD tracking 1 week


Coding & Compliance

CDM

PHLHAND


CPT Coding

PLA code 0364U or CPT 81479


Medical Necessity May Apply
Medical Necessity Documentation

ABN Form