Adaptive Biotech Announces Expansion Of Clonoseq Minimal Residual Disease (MRD) Test

SEATTLE--(BUSINESS WIRE)--Adaptive Biotechnologies, the leader in combining next-generation sequencing and expert bioinformatics to profile T-cell and B-cell receptors of the adaptive immune system, today announced that it is expanding the clonoSEQ^® Process to include minimal residual disease (MRD) analysis of cells harvested from patients with lymphoid cancers being prepared for autologous (“self”) stem cell transplant.

“MRD assessment of autografts can provide prognostic information and may potentially inform treatment decisions about the timing and intensity of post-transplant maintenance therapies.”

Autologous stem cell transplant is a procedure in which a patient’s own stem cells are collected and stored prior to treatment with high dose therapy that, in addition to killing cancer cells, will destroy the majority of a patient’s blood-producing cells. After treatment, the stem cells (also known as an “autograft”) are re-infused into the patient to restore the blood-producing cells. Detection of cancer cells in the autograft product has been shown to predict patient outcome.

“Our expansion of the clonoSEQ MRD Test will allow physicians preparing patients for autologous stem cell transplants to more sensitively measure disease burden,” said Tom Willis, Ph.D., Senior Vice President and General Manager, Diagnostic Products, Adaptive Biotechnologies. “MRD assessment of autografts can provide prognostic information and may potentially inform treatment decisions about the timing and intensity of post-transplant maintenance therapies.”

Physicians wishing to submit autograft samples for MRD analysis should use the clonoSEQ MRD Test Requisition Form and submit the samples using a clonoSEQ Specimen Kit to Adaptive’s CLIA-certified, CAP-accredited laboratory in South San Francisco. Results will be available within seven days of sample receipt via the clonoSEQ Secure Portal.

Adaptive and its academic collaborators will present three abstracts during the American Society of Hematology (ASH) Annual Meeting, December 5-8, 2015 in Orlando, FL, showing that detection of MRD in autografts using the clonoSEQ MRD Test predicts patient outcome post-transplant.

Saturday, December 5, 2015, 5:30 p.m. – 7:30 p.m. ET

• Abstract No. 1420: Quantification of Acute Lymphoblastic Leukemia Clonotypes in Leukapheresed Peripheral Blood Progenitor Cells Predicts Relapse Risk Following Autologous Hematopoietic Cell Transplantation
• Abstract No. 1788: Prognostic Value of Sequencing-Based Minimal Residual Disease Detection in Patients with Multiple Myeloma Who Underwent Autologous Stem Cell Transplantation

Sunday, December 6, 2015, 6:00 p.m. – 8:00 p.m. ET

• Abstract No. 3156: Sequencing-Based Detection of Circulating Tumor DNA in the Autologous Stem Cell Grafts of Patients with Diffuse Large B-Cell Lymphoma Undergoing Hematopoietic Stem Cell Transplantation

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 the Adaptive Biotechnologies clonoSEQ MRD Test, are needed for reliable detection of very low levels of MRD.

About the clonoSEQ^® Process

The 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 the company’s 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 is the pioneer and leader in combining high-throughput sequencing and expert bioinformatics to profile T-cell and B-cell receptors. Adaptive is bringing the accuracy and sensitivity of its immunosequencing platform into laboratories around the world to drive groundbreaking research in cancer and other immune-mediated diseases. Adaptive also translates immunosequencing discoveries into clinical diagnostics and therapeutic development to improve patient care.