Adaptive Biotechnologies, a leading provider of next-generation sequencing assays for the adaptive immune system, has launched clonoSEQ, a clinical assay to measure minimal residual disease (MRD) in a range of blood-based cancers that is significantly more sensitive than today’s most common pathology tests. clonoSEQ will be available for widespread clinical use by mid-2013.

“This new approach of using high throughput sequencing to detect and track residual disease is an important advance for clinical hematologists and their patients,” said Chad Robins, CEO of Adaptive Biotechnologies. “This will help doctors more effectively determine effectiveness of treatments, monitor patient remission status, and personalize future treatments.”

The launch of clonoSEQ follows a key publication in Science Translational Medicine from May 2012, in collaboration with Fred Huchinson Cancer Research Centre and the University of Washington Department of Laboratory Medicine, demonstrating that clonoSEQ detected minimal residual disease in nearly twice the number of patients with T-lineage acute lymphoblastic leukaemia/lymphoma (T-ALL) than flow cytometry.

The highlights of this research will be presented in December 2012, at the Annual Meeting of the American Society of Hematology in Atlanta, Georgia.

Minimal residual disease is the name given to small numbers of leukaemic 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 in the research setting with academic centers worldwide, and has instituted pioneering 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.

These enhancements include: Developing a proprietary set of immune receptor templates to eliminate PCR amplification bias; Instituting a systematic chain of custody to handle customer samples; Building a bioinformatics platform to enable 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.

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

“Without controls in place as reliable as the set of immune receptor templates we have developed to eliminate any PCR bias, standardization of a kit would be quite difficult,” explained Adaptive co-founder Dr Harlan Robins.

Adaptive has several other assays being prepped for clinical use in oncology/hematology, immunology, and infectious diseases.

Adaptive is committed to expanding the use of its platforms as diagnostic tools in clinical trials and as fee-for-service research whereby academic and industry collaborators can incorporate studies of B and T-cell immune repertoire status into their studies.