SOUTH SAN FRANCISCO, Calif. -- (BUSINESS WIRE) -- Sequenta, Inc. today announced that the ClonoSIGHTTM test is now commercially available for patients with multiple myeloma (MM) and diffuse large B-cell lymphoma (DLBCL). The ClonoSIGHT test is the first clinically actionable sequencing-based test for minimal residual disease (MRD) in lymphoid cancers and has been shown to offer unprecedented sensitivity for the detection of rare cancer cells in blood and bone marrow. The test was launched in acute lymphoblastic leukemia, chronic lymphocytic leukemia and mantle cell lymphoma in February 2013.
“Expansion of the ClonoSIGHT test into two new clinically validated indications, multiple myeloma and diffuse large B-cell lymphoma, means that the more than 45,000 people in the United States diagnosed with these diseases each year can benefit from the earliest possible detection of MRD,” said Tom Willis, CEO of Sequenta. “We continue to conduct studies in collaboration with leading academic cancer centers to further demonstrate the technical power of the sequencing-based approach at the core of the ClonoSIGHT test, as well as its value in providing physicians the information they need to make the best decisions for their patients.”
The ClonoSIGHT test uses Sequenta’s proprietary LymphoSIGHT™ platform, which works by sequencing unique DNA signatures present in immune cells. This technology allows tracking of malignant sub-populations present at levels as low as one cell per million white blood cells. The sequencing-based readout provides quantitative results that can be directly interpreted by oncologists.
“Sequenta’s ClonoSIGHT test is enabling clinicians like me who care for patients with lymphoid cancers to take advantage of the sensitivity of next-generation sequencing,” said David Miklos, M.D., Assistant Professor of Medicine, Stanford University Medical Center. “Detecting cancer clones present at extremely low levels allows for better stratification of patient relapse risk, which in turn allows for better treatment decisions. This is especially important in an era of increasingly complex treatment strategies being made possible by the availability of novel agents.”
Clinical validation of the ClonoSIGHT test in MM and DLBCL is based on data to be presented at the upcoming annual meeting of the American Society for Hematology (ASH) taking place in New Orleans, La. December 7-10. A list of presentations using ClonoSIGHT is available at http://sequentainc.com/sequenta-and-collaborators-to-present-new-clonosight-test-data-at-annual-meeting-of-the-american-society-for-hematology/. ASH attendees can learn more about ClonoSIGHT at booth 3122.
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 the LymphoSIGHT™ Platform
Sequenta’s LymphoSIGHT platform is a simple and scalable laboratory process that allows each of the several million B and T cells (lymphocytes) in a blood or tissue sample to be characterized and enumerated. Individual cells can be detected at levels as low as one cell per million white blood cells. The LymphoSIGHT platform combines proprietary multiplexed PCR assays for the universal amplification of rearranged immunoglobulin and T-cell receptor genes with powerful algorithms for the analysis of next-generation sequencing data.
Sequenta has commercialized the LymphoSIGHT platform for clinical use in minimal residual disease (MRD) detection in lymphoid cancers as the ClonoSIGHT™ test. The company is also investigating the use of the LymphoSIGHT platform in a diverse set of immune-mediated diseases and as a method for evaluating the efficacy of therapies based on immune system modulation.
About Multiple Myeloma (MM)
Multiple myeloma (MM) is a blood cancer that arises from antibody (immunoglobulin) producing cells called plasma cells. These cells are mainly found in the bone marrow. Myeloma cells produce large quantities of an abnormal immunoglobulin called M protein. Levels of M protein are used to help determine if a person with myeloma has responded to treatment or is relapsing after treating. According to the American Cancer Society, an estimated 22,350 people in the United States will be diagnosed with MM in 2013 and about 10,710 will die from the disease. Most people diagnosed with MM are at least 65 years old. Fewer than one percent of cases occur in people younger than 35.
About Diffuse Large B-Cell Lymphoma (DLBCL)
Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin lymphoma (NHL) in the United States, accounting for about one third of all cases. 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 69,740 people will be diagnosed with NHL in 2013 and 19,020 will die from the disease. DLBCL affects mostly middle-aged and older 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.