Last Modified:
6/21/2023 8:11:25 AM
Medicare Medical Necessity Restrictions May Apply
Medical Necessity Documentation:
ABN Form
Client Notes:
Patient Preparation:
Specimen Requirements:
2.0 mL Whole Blood or 1.0 mL Bone Marrow in the Lavendar Top Tube (Provided in Kit)
Collection Instructions:
Transport & Storage: Temperature/Stability:
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
Reference Range:
Critical Ranges:
Test Comments:
Methodology:
Polymerase chain reaction (PCR), next-generation sequencing (NGS)
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.
Documentation:
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
Id clonality takes 2 weeks, MRD tracking 1 week
Departments:
PHL Test Code:
CLONO
Included Tests:
CPT Coding:
PLA code 0364U or CPT 81479
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