SEATTLE, Oct. 25, 2013 /PRNewswire/ -- Adaptive Biotechnologies Corporation, a leading provider of next-generation oncology diagnostics, announced today the publication of a method to significantly improve the accuracy of next-generation immune system profiling by creating a fully validated Synthetic Immune System (SISTM) to control for any possible bias caused by the amplification method used to characterize the enormous complexity of the adaptive immune system. The SIS method, developed and validated in Adaptive's Seattle laboratories is described in the October 25th issue of Nature Communications, and demonstrates the Company's fundamental commitment to data quality.
The complexity of the adaptive immune system, marked by millions of distinctly individual cells (called "T-" and "B-"cells) each one of which carries on its surface a unique and distinguishing set of receptors is actually what enables an individual to defend against the vast array of potential pathogens h/she might encounter. A critical first step in profiling the adaptive immune system is the generation of millions of replicas of the individual cell-specific blueprints ("amplification" of the receptor-specific DNA) for these different receptors and then definition of each one of them by high-throughput DNA sequencing. Because of the inherent and important diversity of these receptors, achieving equivalent amplification (critically important to accurately measure the immune response) is problematic.
To correct for this possible amplification bias, Adaptive has created a set of synthetic templates that mimic biological T cell receptor rearrangements. Using molecular design, the relative concentration of each of these templates both before and after amplification can be precisely measured. The amplification process can then be adjusted and corrected so that it is accurate and truthfully represents the level of each receptor present in a given tissue or patient sample.
"Now, with the proven ability to control for bias, the quantitative accuracy essential for clinical decision making is truly possible" explained Dr. Harlan Robins, corresponding author, Adaptive Biotechnologies co-founder and associate faculty member at the Fred Hutchinson Center. As demonstrated in the publication, this SISTM bias control system ensures state-of-the art accuracy of Adaptive's assay in measuring the frequency of biological TCR and BCR rearrangements present in a complex background, including the detection of minimal residual disease (MRD) in patients who suffer from leukemia or lymphoma.
"Adaptive's bias control method has significant business implications in that these templates will be used as a set of in-line controls for all Adaptive research and clinical assays going forward. Of particular importance, this advance enables Adaptive to develop a kit for outside laboratories to perform this bias-controlled assay at their own sites. These bias control templates will ensure cross-lab standardization," noted CEO and co-founder, Chad Robins. This product will be marketed first as a Research Use Only product, but the Company intends to seek 510K clearance for in vitro diagnostic products, initially focused in oncology.
About Adaptive Biotechnologies
Adaptive Biotechnologies Corporation ("Adaptive" or the "Company") is a pioneer in immunosequencing diagnostics, with a focus in oncology. The Company leverages advances in next generation sequencing ("NGS") to profile T-Cell and B-Cell Receptors ("TCRs" and "BCRs"). This breakthrough enables in-depth characterization of the immune system, which is the primary defense against cancer. By incorporating immunosequencing into clinical care, Adaptive can enhance the diagnosis, prognosis, and monitoring of cancer patients. The Company's first clinical application, clonoSEQTM, is for monitoring Minimal Residual Disease ("MRD") in blood-based cancers. The Company recently launched clonoSEQTM as a CLIA certified Laboratory Developed Test ("LDT") in the second quarter of 2013. Improving the ability to accurately detect and track residual disease at a molecular level affords clinicians the potential to detect relapse earlier and improve patient care. Adaptive is currently validating additional oncology diagnostics to quantify the presence and clonality of Tumor Infiltrating Lymphocytes ("TIL") and to create a reliable measure of "immunocompetency" to predict or monitor response to cancer treatments that directly alter the host immune system. Adaptive incubates and validates potential clinical products by offering fee-for-service access to its proprietary immune profiling sequencing technology under the brand name immunoSEQTM.
SOURCE Adaptive Biotechnologies Corporation