Assay Detects Minimal Residual Disease in Blood Based Cancers

Adaptive Biotechnologies (Seattle, WA, USA), a provider of next-generation sequencing assays for the adaptive immune system, has launched clonoSEQ, a clinical assay that measures minimal residual disease (MRD) in a range of blood-based cancers that is significantly more sensitive than today’s most common pathology tests.

Minimal residual disease refers to small numbers of leukemic cells that remain in the patient during treatment or after treatment when the patient is in remission. The number of these residual cells may be, in some cases, correlated with the risk of relapse. Knowledge of MRD can influence clinical care and increase cure rates.

Adaptive has extensive experience applying its MRD assay for research in centers worldwide, and has instituted quality control measures to markedly improve the accuracy and sensitivity of MRD testing as well as simplify data reporting to make comprehension easier and quicker for hematologists.

The company developed a set of immune receptor templates to eliminate polymerase chain reaction (PCR) amplification bias. It has instituted a systematic chain of custody to handle customer samples. Its bioinformatics platform enables the measurement of MRD as a ratio of the malignant clone to the total number of nucleated cells in a blood sample as well as to the lineage-related cells.

The launch of clonoSEQ follows demonstration by Adaptive Biotechnologies, in collaboration with the Fred Hutchinson Cancer Research Center and the University of Washington department of laboratory medicine, that clonoSEQ detected minimal residual disease in nearly twice the number of patients with T-lineage acute lymphoblastic leukemia/lymphoma (T-ALL) than flow cytometry. The study was published in the May 2012 journal Science Translational Medicine.

Future plans for clonoSEQ include the development and distribution of a proprietary kit that would allow for the assay to be performed in point-of-need clinical pathology laboratories.

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