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Sequenta’s Next-Generation Sequencing-Based Minimal Residual Disease (MRD) Quantification Technology Shown to Predict Post-Transplant Relapse and Survival in Adult Acute Lymphoblastic Leukemia (ALL) Patients

May 8, 2014

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Sequenta, Inc. and collaborators have published results demonstrating that the company’s next-generation sequencing-based minimal residual disease (MRD) quantification technology, available clinically as the ClonoSIGHT™ test, provides important prognostic information about adult patients with acute lymphoblastic leukemia (ALL) who receive donor stem cell transplants. Analysis of post-transplant blood samples with Sequenta’s method predicted both relapse and survival and detected evidence of disease a median of three months prior to clinical relapse.

“Minimal residual disease testing has become a standard of care in the management of pediatric ALL, but routine assessment of MRD in adult patients remains uncommon due to the varied diagnostic capabilities of hospitals across the country and the usual requirement for bone marrow samples,” said Aaron Logan, M.D., Ph.D., Assistant Professor, UCSF School of Medicine, lead author of the study. “The ClonoSIGHT test has the advantages of being standardized and sufficiently sensitive to detect MRD in blood samples, making it a powerful tool for assessing responses to treatment and for studying methods to improve patient outcomes by intervening on progressive MRD instead of awaiting overt relapse.”

Analysis of blood samples from 29 adults with ALL who received donor stem cell transplants found that patients who were MRD-positive (greater than one leukemia cell per one million total white blood cells) within the first 90 days post-transplant had significantly increased risk of relapse (HR=14; 95% CI 4.7 – 44; p<0.0001). Patients who were MRD-positive at any point post-transplant (17 of 25 evaluable patients) all relapsed and died from their disease (median survival=359 days; range 85-1991 days). The median lead-time from MRD detection to clinical relapse was 89 days (range 0-207 days). Of the eight patients who maintained MRD-negativity, six remain alive at a median of 1853 days post-transplant (range 1641-2732) and two died from complications of graft-versus-host disease without evidence of leukemia recurrence.

“Sequenta’s ClonoSIGHT test allows me to measure MRD in my post-transplant patients with a simple blood draw on a regular basis, which has the potential to help me detect disease before a patient is in overt relapse,” said David Miklos, M.D., Ph.D., Assistant Professor of Medicine, Stanford University Medical Center, senior author of the study. “I am adopting the ClonoSIGHT MRD test into the management of my post-transplant ALL patients, as well as patients being treated for other lymphoid cancers, such as chronic lymphocytic leukemia.”

“The ClonoSIGHT test, offered through Sequenta’s CLIA-certified laboratory, enables broad access to ultra-sensitive MRD testing for patients with ALL and other lymphoid cancers,” said Tom Willis, Sequenta CEO. “ClonoSIGHT is emerging as a clinical standard in both clinical trials and routine practice as a way to better understand treatment response and patient prognosis, and as a way to guide appropriate treatment decisions.”

The study, “Immunoglobulin and T-cell receptor gene high-throughput sequencing quantifies minimal residual disease in acute lymphoblastic leukemia and predicts post-transplant relapse and survival,” by Logan, et al., is available online ahead of print in Biology of Blood and Marrow Transplantation (http://www.bbmt.org/article/S1083-8791(14)00257-2/abstract).

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. Very low levels of MRD can be reliably detected only by using sensitive molecular technologies, such as the next-generation sequencing utilized by Sequenta’s ClonoSIGHT test.

About the ClonoSIGHT™ Test

Sequenta’s ClonoSIGHT test enables physicians to utilize sequencing-based minimal residual disease (MRD) detection as a clinical decision-making tool for patients with lymphoid cancers (blood cancers). Testing for MRD can help determine whether treatment has been successful, provide important information about patient prognosis and help guide additional treatment decisions. Clinical validation studies have shown that the ClonoSIGHT test, which utilizes Sequenta’s LymphoSIGHT™ platform, offers significant improvements in sensitivity and performance over traditional MRD detection methods.

The ClonoSIGHT test uses a two-step process that is easily integrated into patient care. First, cancer cell DNA sequences are identified in a diagnostic sample. Follow-up samples are then screened for these sequences to detect MRD. ClonoSIGHT test results, which are generated in seven days using Sequenta’s CLIA-certified laboratory, are provided in a simple, actionable report that shows a patient’s MRD status and level, as well as MRD trends over time.

About Acute Lymphoblastic Leukemia (ALL)

Acute lymphoblastic leukemia (ALL) is an aggressive blood cancer that arises from immature B or T cells. ALL cells develop in the bone marrow and then invade the blood. The American Cancer Society estimates that 6,020 people in the United States will be diagnosed with ALL in 2014 and 1,440 will die from the disease. ALL mainly affects children, with only about one third of cases occurring in adults. Most deaths (approximately 4 out of 5) occur in adults.

About Sequenta

Sequenta is a venture-backed biotechnology company dedicated to improving patient care in diseases mediated by immune cells through the discovery and development of novel clinical diagnostics. The company, located in South San Francisco, was founded in 2008 and has received funding from Mohr Davidow Ventures, Index Ventures and Foresite Capital. For more information, please visit www.sequenta.com.




Sequenta, Inc.

Sylvia Zaich, 949-244-3718

sylvia.zaich@sequenta.com


Source: Sequenta, Inc.


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