Sequenta’s ClonoSIGHT Test to Be Used by the Dana-Farber Cancer Institute (DFCI)/Acute Lymphoblastic Leukemia (ALL) Consortium
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sequenta, Inc. today announced that the DFCI/ALL Consortium will utilize the ClonoSIGHT™ test, the first sequencing-based test for minimal residual disease (MRD) in lymphoid cancers, for clinical care of children with ALL.
“Use of the ClonoSIGHT test by the DFCI/ALL Consortium is the result of the extensive clinical validation studies we have conducted and the trust we have built with physicians at major cancer centers across the nation”
“Children with a high MRD level at the end of the first month of treatment have been shown to have a much higher risk of relapse compared to those with a low level of MRD. We now assess MRD as part of our treatment protocol and intensify therapy for children with high levels,” said Stephen Sallan, MD, pediatric oncologist at Dana-Farber/Boston Children’s Cancer and Blood Disorders Center and DFCI/ALL Consortium Principal Investigator. “We are beginning to use the ClonoSIGHT test for MRD detection because we believe it will further our mission to improve outcomes for children with ALL.”
The Consortium currently uses a method for measuring MRD, allele-specific oligonucleotide PCR (ASO-PCR), which is less sensitive than the ClonoSIGHT test and takes several weeks to deliver results. During an initial validation period, the two methods will be used in parallel, and ClonoSIGHT test results will be relied upon to make clinical decisions in those cases where the ASO-PCR method fails. Eventually, however, the Consortium intends to adopt the ClonoSIGHT test to guide treatment decisions for all patients.
“Use of the ClonoSIGHT test by the DFCI/ALL Consortium is the result of the extensive clinical validation studies we have conducted and the trust we have built with physicians at major cancer centers across the nation,” said Tom Willis, CEO of Sequenta. “We are pleased that the physicians in the DFCI/ALL Consortium and, most importantly, their patients will begin to benefit from the ClonoSIGHT test’s ultra-sensitive measurement of MRD and seven day turnaround time, which will allow timely incorporation of MRD results into crucial therapy decisions.”
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 estimated that 6,070 people in the United States would be diagnosed with ALL in 2013 and 1,430 would 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.
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.