Clinical Applications: Oncology

A clinical assay to measure minimal residual disease in a range of blood cancers.
ClonoSEQ RegionsClonoSEQ is a set of CLIA-standardized assays developed by Adaptive for highly sensitive (approximately 10^6) detection of Minimal Residual Disease (MRD) in leukemia and lymphoma patients.

The assay focuses on T-cell receptor or B-cell receptor (Ig) Complementarity Determining Region 3 (CDR3) chains. The nucleotide sequences that encode the CDR3 regions are generated by site-specific recombination between genomic variable (V), diversity (D), and joining (J) region gene segments (top figure).

Diversity of the CDR3 chains is augmented by the deletion and template-independent insertion of nucleotides at the V-D and D-J junctions. Because of this inherent diversity of receptor formation, it is highly improbable to independently create the same CDR3 nucleotide sequence twice, effectively making each CDR3 sequence a unique nucleotide tag for any specific T-cell or B cell and its clonal descendants (middle figure). This unique nucleotide tag (bottom figure) is the marker utilized to track the malignant T or B cell over time via a proprietary multiplex PCR technology paired with next generation sequencing and refined computational analysis.

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Quantifying TILs for Prognostic Score
Tumor-infiltrating lymphocytes (TILs) are white blood cells that have left the bloodstream and migrated into a tumor. When numerous, TILs are considered to be an immunologic biomarker, garnering global attention, because of the correlation between the presence of TILs and outcome in several tumor types.

Adaptive is currently in the process of working with 10 institutions and several pharmaceutical companies to test its technology and its ability to detect and “count” the TILs with the goal of leading to improved prediction of patient outcome.