New Study Shows Adaptive Biotechnologies immunoSEQ Assay Significantly More Sensitive than Traditional Method to Detect Minimal Residual Disease in Leukemia
Adaptive Biotechnologies, Fred Hutchinson Cancer Research Center, and University of Washington Study Demonstrates Clinical Utility of Next-Generation Immune Profiling Technology
SEATTLE, WA, May 16, 2012 – Adaptive Biotechnologies Corporation, a leading provider of next-generation sequencing assays for the adaptive immune system, announced today results from the first head-to-head comparison of high throughput sequencing (HTS) using immunoSEQ™ and traditional flow cytometry. The study, which was conducted in collaboration with Fred Hutchinson Cancer Research Center and the University of Washington Department of Laboratory Medicine, was published in the May 16th issue of Science Translational Medicine and demonstrated that immunoSEQ detected minimal residual disease (MRD) in nearly twice the number of patients with the blood cancer T-lineage acute lymphoblastic leukemia/lymphoma (T-ALL) than flow cytometry.
“Minimal residual disease is a major predictor of relapse in blood cancers. Our study results highlight the potential of HTS technology to define lower detection thresholds for MRD that could impact clinical treatment decisions,” explained Dr. Harlan Robins, corresponding author, Adaptive Biotechnologies co-founder and associate faculty member at the Hutchinson Center. “Improving the ability to consistently detect and track residual disease at a molecular level affords clinicians the ability to predict relapse earlier and improve patient care.”
In the study, Adaptive’s immunoSEQ assay and University of Washington’s flow cytometry assay were used to identify the primary cancer clone in 43 patients diagnosed with T-ALL. Each patient then underwent chemotherapy treatment. After 29 days, the two assays were used to detect MRD, the small number of cancer cells that may remain after treatment. HTS was significantly more sensitive than flow cytometry at detecting subsequent minimal residual disease post-treatment. HTS identified MRD in 10 cases missed by flow cytometry (22 vs. 12, respectively). The study also showed that the immunoSEQ platform could detect 1 in 200,000 clones as compared to 1 in 10,000 clones for flow cytometry, representing a 20-fold difference in sensitivity.
ImmunoSEQ is a breakthrough solution for immune profiling that provides a sensitive, reliable and cost-effective method for researchers to accurately evaluate overall T cell receptor repertoire diversity at a specific point in time to diagnose disease and over a span of time to monitor disease.
“We have clearly demonstrated the power of next-generation immune sequencing for clinical monitoring applications, such as MRD,” explained Adaptive Biotechnologies CEO, Chad Robins. “Adaptive is leading the effort to demonstrate the clinical relevance of high throughput immune profiling for disease detection, monitoring and personalized treatment decisions in cancer and numerous immune disorders.”
In addition to its greater sensitivity, HTS offers many advantages over flow cytometry. Since HTS can detect any pre-identified clone and is performed in a centralized lab, it consistently generates reproducible and reliable results regardless of disease type using the same process for disease detection and tracking. In contrast, flow cytometry is specific to a known subset of cancerous surface markers that vary by cancer subtype and uses different processes for identification and tracking. Furthermore, HTS is highly automated, cost-effective and objective; whereas, flow cytometry is more time-consuming, relies on the skill of the operator and is subject to human error.
Adaptive, the Hutchinson Center, and University of Washington will track clinical outcomes from the 43 patients in this trial to validate the clinical relevance of a lower detection threshold for MRD. The laboratories are also working together on a similar trial in a significantly larger population of patients with various forms of leukemia and lymphoma. In addition, Adaptive is running other confirmatory studies around the globe with leading academic institutions and biopharmaceutical companies.
About Adaptive Biotechnologies Corporation and immunoSEQ™
Adaptive Biotechnologies Corporation (http://www.adaptivebiotech.com), headquartered in Seattle, WA, is pioneering the field of genomic immunology. The company’s core competency is developing next generation sequencing assays that characterize the adaptive immune system, serving as a platform technology to the research community and the biopharmaceutical industry. Its flagship commercial product, immunoSEQ (http://www.immunoSEQ.com), uses a proprietary immune profiling assay to analyze T cells and B cells – critical components of the adaptive immune system’s defense against disease – with unprecedented depth and specificity. Sequencing the variable region of these immune cells allows researchers to characterize the complete immune repertoire of a patient or group of patients in search of immunologic biomarkers. Fueled by discoveries from immunoSEQ, the company is currently developing a pipeline of clinical assays that are specific to cancer diagnosis and prognosis. All of Adaptive Biotechnologies’ assays are coupled with a cloud-computing infrastructure that simplifies the interpretation of massive quantities of data in a user-friendly interface. immunoSEQ was launched in September 2010 and has a worldwide customer base.