Adaptive Biotechnologies, Seattle, introduces clonoSEQ, a clinical assay to measure minimal residual disease (MRD) in a range of blood-based cancers.
The assay 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, 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 Center 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 leukemia/lymphoma (T-ALL) than flow cytometry, according to the company.
Minimal residual disease is the name given 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 in the research setting with academic 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 says. 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,” said Adaptive co-founder Harlan Robins, PhD. Adaptive has several other assays being prepped for clinical use in oncology/hematology, immunology, and infectious diseases.The company remains 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.