IgH Clonality by NGS

  • Next Generation Sequencing (NGS)
The IgH Clonality by NGS assay detects clonal populations of B-lymphocytes in a given patient sample through the analysis of the VDJ segment of the immunoglobulin heavy chain (IgH) gene.
Turnaround time
14 Days

Level of Service

  • Global
New York Approved: No

Clinical Significance

The IgH Clonality by NGS test is designed to detect clonal populations of B-lymphocytes in a given patient sample through the analysis of the VDJ segment of the immunoglobulin heavy chain (IgH) gene. Detecting the presence of clonal B-lymphocyte populations is important for the diagnosis of B-cell lymphoma or leukemia. Additionally, this test provides important information on somatic hypermutations in the neoplastic clone as well as tumor heterogeneity.

The presence of more than one clone or subclones within the B-cell lymphoma/leukemia cells can also be determined by this assay. The IgH Clonality by NGS test is also useful for monitoring patients with B-cell lymphoma/leukemia due to its high sensitivity and its quantitative nature. Using this technology has been reported to be reliable in monitoring patients with diffuse large B-cell lymphoma (DLBCL) and acute lymphoblastic lymphoma (ALL).

Specimen Requirements

Bone Marrow Aspirate: 2 mL in EDTA tube.
Peripheral Blood: 5 mL in EDTA tube.
H&E slide (required) plus paraffin block.
Cut Slides: H&E slide (required) plus 5-10 unstained slides cut at 5+ microns.
Note on FFPE: Paraffin block is preferred. Do not use zinc fixatives. If submitting slides, please use positively-charged slides and 10% NBF fixative. Block and slide identifiers should be clearly written and match exactly with the specimen ID and specimen labeling as noted on the requisition.
Note: Test is DNA-based. Please select Extract & Hold - DNA If specimen hold service is desired.

Storage and Transportation

Use cold pack for transport, making sure cold pack is not in direct contact with specimen. For fresh samples: refrigerate before shipping and ship same day as drawn whenever possible. Do not freeze. Please select extract & hold - DNA if specimen hold service is desired.

CPT Code(s)*

81263x1

*The CPT codes provided with our test descriptions are based on AMA guidelines and are for informational purposes only. Correct CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed.

Last Updated: August 27, 2025

Get in touch

Our Client Services team is on hand to help. Please call us at 866.776.5907, Option 3.