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TMCNet:  Sequenta's ClonoSIGHT Test Validated in Multiple Myeloma by Data to be Presented at Annual Meeting of the American Society of Hematology

[December 07, 2013]

Sequenta's ClonoSIGHT Test Validated in Multiple Myeloma by Data to be Presented at Annual Meeting of the American Society of Hematology

NEW ORLEANS --(Business Wire)--

Sequenta, Inc. today announced that researchers will present data at the 55th annual meeting of the American Society of Hematology (ASH) demonstrating that Sequenta's ultra-sensitive method for minimal residual disease (MRD) detection is prognostic for both time to tumor progression (TTP) and overall survival (OS) in patients who have been treated for multiple myeloma (MM). Sequenta's recent announcement of the commercial launch of the ClonoSIGHT™ test for use in MM patients is based on this clinical validation data.

"Because of recent advancements in multiple myeloma therapy, most patients achieve complete remission after first-line therapy, but we know that many of them will relapse due to the persistence of residual tumor cells," said Nikhil Munshi, M.D., Associate Professor, Dana Farber Cancer Institute. "The ClonoSIGHT test is a sensitive and reproducible method for detecting and monitoring MRD with next-generation sequencing that can help guide therapeutic decisions and improve outcomes in these patients."

Researchers from Hospital Universitario 12 de Octubre led by Joaquin Martinez-Lopez, M.D., Ph.D., found that TTP and OS were significantly longer in MM patients determined to be MRD negative by Sequenta's assay post-treatment than in patients who were MRD positive (TTP, median 80 vs. 31 months, p<0.0001; and OS, median not reached vs. 81 months, p=0.02). Additionally, when patients in complete remission as determined by conventional criteria were stratified into MRD negative and positive groups by the Sequenta assay, the researchers found TTP was significantly better in the MRD negative group (median 131 vs. 35 months, p=0.0009; Abstract #1848: Prognostic Value Of Deep Sequencing Approach For Minimal Residual Disease (MRD) Detection In Multiple Myeloma Patients; Saturday, December 7, 5:30-7:30 p.m. CT; Hall G).

"These data show that the ClonoSIGHT test can detect MRD in multiple myeloma patients who are otherwise considered to be in remission, and that the presence of these small numbers of cells has a real impact on prognosis," said Tom Willis, CEO of Sequenta. "The ClonoSIGHT test is a powerful method for patient risk stratification that can now be integrated into clinical trials and personalized treatment approaches, such as de-escalation of therapy for MRD-negative patients or continuous escalation of treatment for MRD-positive patients."

On Monday December 9, Dr. Munshi will deliver an oral presentation of data showing that in addition to providing prognostic information, Sequenta's technology can also detect multiple cancerous B cell clones in some MM patients. Data gathered using the company's method for immune cell analysis (called the LymphoSIGHT™ platform) suggests that this can be due to either multiple original cancer cells or the evolution of a single cancer cell after the original malignant lesions occur. These findings shed light on the biology and pathogenesis of MM and could eventually be used to provide additional prognostic information about patients (Abtract #401: Deep Sequencing Reveals Oligoclonality At The Immunoglobulin Locus In Multiple Myeloma Patients; Monday, December 9, 11:30 a.m. CT; Room 388-390).


Additional data demonstrating the utility of the ClonoSIGHT test for MRD detection in MM will be presented by Sequenta collaborators at ASH.

  • Abstract #1843: A Comparison Between Next-Generation Sequencing and ASO-qPCR For Minimal Residual Disease Detection In Multiple Myeloma: The Clinical Value In ASCT Setting (Poster; Saturday, 5:30-7:30 p.m.)
  • Abstract #1902: Minimal Residual Disease (MRD) Detection By Deep Sequencing In Newly Diagnosed Multiple Myeloma Patients Treated With Carfilzomib, Lenalidomide and Dexamethasone (Poster; Saturday, 5:30-7:30 p.m.)
  • Abstract #3220: Predictors Of Treatment Outcome With The Combination Of Carfilzomib, Lenalidomide, and Low-Dose Dexamethasone (CRd) In Newly Diagnosed Multiple Myeloma (NDMM) (Poster; Sunday, 6:30-8:30 p.m.)

Sequenta and its collaborators from academic institutions around the world will share data demonstrating the validity and prognostic value of the ClonoSIGHT test in a total of four oral and 13 poster presentations at ASH this year, encompassing eight different blood cancer subtypes. A complete list of Sequenta abstracts can be found at: http://sequentainc.com/sequenta-and-collaborators-to-present-new-clonosight-test-data-at-annual-meeting-of-the-american-society-for-hematology/.

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 (News - Alert) 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 treatment. 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 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.


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