Adaptive Biotechnologies' clonoSEQ Minimal Residual Disease Test Detects Relapse with Higher Specificity than PET/CT in Diffuse Large B-Cell Lymphoma Patients

SEATTLE, April 22, 2015 /PRNewswire/ -- Adaptive Biotechnologies today announced the recent publication of a study demonstrating that analysis of circulating tumor DNA (ctDNA) using the company's next-generation sequencing-based minimal residual disease detection and quantification method (clinically-available as the clonoSEQ™ MRD test) can detect relapse in diffuse large B-cell lymphoma (DLBCL) patients with significantly higher specificity than positron emission tomography combined with CT (PET/CT).

"We found that circulating tumor DNA reflected tumor burden and detected disease at the same time or before PET/CT in relapsed patients," said Malek Faham, MD, PhD, Senior Vice President, Innovation, Adaptive Biotechnologies, and an author of the study. "Serial monitoring of circulating tumor DNA is a potentially useful means for disease surveillance post-treatment that avoids the cost and radiation exposure characteristic of imaging modalities."

Fifty-one surveillance blood samples from 25 patients who achieved complete remission were analyzed. Of the five patients who eventually relapsed, three had detectable ctDNA prior to relapse as detected by PET/CT scan (median lead time 88 days, range 14-162 days). The remaining two patients had detectable ctDNA at the time of relapse as detected by PET/CT scan. The specificity of ctDNA detection during surveillance was 100% (0 false positives), whereas the specificity of PET/CT was 56% (3 false positives; difference was statistically significant, p<0.0001). The difference in sensitivity between ctDNA and PET/CT was not statistically significant.

"Detecting relapse early in DLBCL patients has the potential to improve outcomes, but the imaging methods currently used for surveillance monitoring produce high rates of both false negative and false positive results," said Tom Willis, PhD, Senior Vice President and General Manager, Diagnostic Products, Adaptive Biotechnologies. "Multiple studies have now shown that the clonoSEQ MRD test can sensitively and specifically detect circulating DLBCL tumor DNA in blood samples, many times months before relapse is detected on a scan."

The study, "Non-invasive monitoring of diffuse large B-cell lymphoma by immunoglobulin high-throughput sequencing," by Kurtz et al. is available online ahead of print in Blood (DOI: http://dx.doi.org/10.1182/blood-2015-03-635169).

About Diffuse Large B-Cell Lymphoma (DLBCL)
Lymphomas are blood cancers that develop in the lymphatic system. There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). NHL mainly affects adults (95 percent of cases), with about half of patients diagnosed when they are over age 65. The American Cancer Society estimates that approximately 71,850 people will be diagnosed with NHL in 2015 and 19,790 will die from the disease. Diffuse large B-cell lymphoma (DLBCL) is the most common type of NHL in the United States, accounting for about one third of all cases.

About Minimal Residual Disease
Minimal residual disease (MRD) refers to cancer cells that may remain in the body of a person with lymphoid cancer after treatment. These cells are present at levels undetectable by traditional microscopic examination (also called morphologic examination) of blood, bone marrow or a lymph node biopsy. Sensitive molecular technologies, such as the next-generation sequencing utilized by Adaptive Biotechnologies' clonoSEQ MRD test, are needed for reliable detection of very low levels of MRD.

About the clonoSEQ Process
Adaptive Biotechnologies' clonoSEQ process enables physicians to utilize sequencing-based minimal residual disease (MRD) detection as an aid to clinical decision making for patients with lymphoid cancers (blood cancers). With its ability to detect cancer cells at a level as low as one per one million white blood cells, the clonoSEQ MRD test is one to two orders of magnitude more sensitive than other methods of MRD detection, such as ASO-PCR and flow cytometry. The clonoSEQ process was previously marketed as the ClonoSIGHT™ process by Sequenta, Inc., which was acquired by Adaptive Biotechnologies in January 2015.

MRD detection and quantification using the clonoSEQ process involves two steps that are easily integrated into patient care. In the first step, the clonoSEQ ID test, cancer cell DNA sequences are identified in a diagnostic sample. In the second step, the clonoSEQ MRD test, follow-up samples are screened for the previously identified sequences in order to detect residual disease. ClonoSEQ test results are generated in seven days using Adaptive Biotechnologies' CLIA-certified, CAP-accredited laboratory. These results are provided to the ordering physician in a simple, actionable report that shows a patient's MRD status and level, as well as MRD trends over time via a secure online portal.

About Adaptive Biotechnologies
Adaptive Biotechnologies Corporation is a platform-based, diagnostic-driven company that leverages NGS to profile T-Cell and B-Cell Receptors. 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. For more information, please visit AdaptiveBiotech.com.

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