clonoSEQ

Overview

  • EPIC Code:
  • Soft Test Code:
  • CLONO
Included Tests

B-Cell Clonality ID; IGHV Mutation Status; B-Cell Tracking (MRD)


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:

-OR-

2.0 mL Whole Blood in a Lavender Top Tube - EDTA
Transport and Storage:
  • Ambient: 5 Days

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

-OR-

1.0 mL Bone Marrow in the Lavendar Top Tube
Transport and Storage:
  • Ambient: 4 Days

    Specimens stable withing the clonoSEQ shipper for ambient, summer and winter shipping conditions

Clinical Interpretation

Reference Range:

Refer to Interprative Report


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

Sites Performed
  • Adaptive Biotechnologies
Days Performed
Friday
Departments
  • Sendouts - Clinical
Turn Around Time

Id clonality takes 2 weeks, MRD tracking 1 week


Coding & Compliance

CDM

Billed to Patient Adaptive pays Parkview for collection


CPT Coding

PLA code 0364U or CPT 81479


Medical Necessity May Apply
Medical Necessity Documentation

ABN Form