Study Reports clonoSEQ™ Detects Residual Disease in 33% More Childhood Leukemia Patients Compared to Current Standard of Care Laboratory Test

Study published in Clinical Cancer Research and co-led by Adaptive Biotechnologies and the University of Washington demonstrates clinical utility of Next Generation Immune Profiling

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Adaptive Biotechnologies

Jun 27, 2014, 11:01 ET

SEATTLE, June 27, 2014 /PRNewswire/ -- Adaptive Biotechnologies today announced results demonstrating enhanced accuracy and sensitivity of clonoSEQ in identifying risk of relapse in patients with B-cell Acute Lymphoblastic Leukemia (B-ALL), a childhood leukemia, compared to flow cytometry, the current standard of care laboratory test. The study, conducted on Children's Oncology Group protocol AALL0932 at the University of Washington, was published online today in Clinical Cancer Research.

"Minimal residual disease (MRD) is used to predict risk of relapse in blood cancers such as B-ALL. Our study results highlight the improved accuracy and sensitivity of clonoSEQ, and the potential need to redefine detection thresholds for MRD to improve the way patients with B-ALL are monitored during and after treatment," explained Dr. Harlan Robins, corresponding author, Adaptive Biotechnologies co-founder and associate faculty member at the Hutchinson Center.

In the 99 patient childhood B-ALL study, Adaptive's clonoSEQ assay and the University of Washington flow cytometry assay were used to identify the primary cancer clone in pre-treatment bone marrow samples and track the cancerous clone in bone marrow samples taken at Day 29 post-chemotherapy treatment. clonoSEQ identified MRD in 28 cases missed by flow cytometry, where the MRD was present at a 10-to-100 fold lower detection level than in the 23 patients where both clonoSEQ and flow cytometry identified MRD. Importantly, seven of the cases missed by flow cytometry were above the level of detection that is required for clinical decision-making based on flow-cytometry (1 in 10,000 cells). Further analysis performed on those seven samples showed post-treatment changes in the cancer cell surface markers that flow cytometry was unable to detect.

"Accurately measuring minimal residual disease is a critical component of patient care in acute leukemias," says Dr. David Wu, Associate Professor in the Department of Laboratory Medicine at the University of Washington. "Next-generation sequencing is a very promising technology that could greatly improve on current approaches for MRD detection."

Adaptive has several other publications planned over the next six months demonstrating the relevance of low level MRD and risk of relapse, supporting the potential benefits of incorporating a more accurate, sensitive, and standardizable HTS technique into the clinic.

About Adaptive Biotechnologies

Adaptive Biotechnologies Corporation is a platform-based, diagnostic-driven company that leverages next generation sequencing ("NGS") to profile T-Cell and B-Cell Receptors ("TCRs" and "BCRs"). This breakthrough enables in-depth characterization of the adaptive 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.

About clonoSEQ^TM

Adaptive's first CLIA certified clinical application, clonoSEQ^TM, is for monitoring Minimal Residual Disease ("MRD") in blood-based cancers. 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.

About immunoSEQ^TM

Adaptive incubates and validates potential clinical products in oncology, autoimmune disorders, and infectious diseases by offering fee-for-service access to its proprietary immune profiling sequencing technology under the brand name immunoSEQ^TM. Adaptive will be introducing an immunoSEQ Kit for research use only in the fall of 2014 to facilitate the integration of immunosequencing into research centers globally.

Using the immunoSEQ platform, the company is currently validating a second novel oncology diagnostic 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.

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SOURCE Adaptive Biotechnologies