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Sequenta and Collaborators to Present Data on ClonoSIGHT MRD Test at American Society of Hematology Annual Meeting

Events, Press Releases

15 presentations focus on next-generation sequencing-based MRD detection in a range of blood cancers, including diffuse large B-cell lymphoma and multiple myeloma

SOUTH SAN FRANCISCO, Calif. NOVEMBER 6, 2014 – Sequenta, Inc. and its academic collaborators will present data on the ClonoSIGHT™ minimal residual disease (MRD) test in one oral and 14 poster presentations at the American Society of Hematology Annual Meeting (ASH), December 6-9, 2014 in San Francisco, Ca. The presentations, covering more than 10 different blood cancer subtypes, continue to establish the prognostic power of the ClonoSIGHT MRD test, as well as suggesting its validity in surveillance monitoring and revealing new insights into the biology of these diseases.

“The breadth of clinical data, we are presenting at ASH 2014, further demonstrates our commitment to thorough clinical validation of the ClonoSIGHT test for MRD detection and quantification,” said Tom Willis, CEO of Sequenta. “Our technology provides an ultra-sensitive, standardized method for understanding patient prognosis and determining treatment response to both physicians treating patients and pharmaceutical companies using MRD assessment in clinical trials.”

The oral presentation information is as follows:

Abstract #139: Monitoring of Circulating Tumor DNA As Minimal Residual Disease in Diffuse Large B-Cell Lymphoma
Presenter: Mark Roschewski, MD (NCI)
Session: Non-Hodgkin Lymphoma: Biology, excluding Therapy I
Presentation time: Sunday, December 7, 2014, 4:30 p.m. PT
Location: North Building, 120-125 (Moscone Center)

The poster presentation information is as follows:

Session: Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster I
Presentation time: Saturday, December 6, 2014, 5:30-7:30 p.m. PT
Location: North Building, Hall E (Moscone Center)

  • Abstract #1186: Ibrutinib Treatment of Relapsed CLL Following Allogeneic Transplantation: Sustained Disease Response and Promising Donor Immune Modulation

Session: Hodgkin Lymphoma: Biology, excluding Therapy: Poster I
Presentation time: Saturday, December 6, 2014, 5:30-7:30 p.m. PT
Location: West Building, Level 1 (Moscone Center)

  • Abstract #1610: Sequence Level Analysis of Hodgkin Lymphoma Clonotypes Detected in Peripheral Blood Using a Next-Generation Sequencing Approach
  • Abstract #1680: High Frequency of Identical Lymphoma Clones Detected in Pre-Treatment Tumor and Plasma from Untreated Patients with HIV-Associated Lymphomas: Prospective Multicenter Trial of the AIDS Malignancy Consortium (AMC 064)

Session: CLL: Biology and Pathophysiology, excluding Therapy: Poster I
Presentation time: Saturday, December 6, 2014, 5:30-7:30 p.m. PT
Location: West Building, Level 1 (Moscone Center)

  • Abstract #1960: Next-Generation IgVH Sequencing of Monoclonal B-Cell Lymphocytosis Reveals Clonal Heterogeneity, Ongoing Mutation, and Repertoire Differences Relative to Chronic Lymphocytic Leukemia

Session: Myeloma: Biology and Pathophysiology, excluding Therapy: Poster I
Presentation time: Saturday, December 6, 2014, 5:30-7:30 p.m. PT
Location: West Building, Level 1 (Moscone Center)

  • Abstract #2003: Prognostic Value of Sequencing-Based Minimal Residual Disease Detection in Multiple Myeloma
  • Abstract #2005: Deep Sequencing of Immunoglobulin Loci Reveals Evolution of IgH Clone in Multiple Myeloma Patients over the Course of Treatment
  • Abstract #2010: Assessment of Tumor Depletion Following Tandem Mobilization in Multiple Myeloma Patients Receiving Autologous Stem Cell Transplantation
  • Abstract #2036: Identification Rate of Myeloma-Specific Clonotypes in Multiple Diagnostic Sample Types from Patients with Multiple Myeloma Using Next-Generation Sequencing Method

Session: Myeloma: Therapy, excluding Transplantation: Poster I
Presentation time: Saturday, December 6, 2014, 5:30-7:30 p.m. PT
Location: West Building, Level 1 (Moscone Center)

  • Abstract #2105: Minimal Residual Disease (MRD) Testing in Newly Diagnosed Multiple myeloma (MM) Patients: A Prospective Head-to-Head Assessment of Cell-Based, Molecular, and Molecular-Imaging Modalities
  • Abstract #2127: Minimal Residual Disease Status Predicts Progression-Free Survival in Newly Diagnosed Multiple Myeloma (NDMM) Patients Treated with Carfilzomib, Lenalidomide, and Low-Dose Dexamethasone (KRd)

Session: Acute Lymphoblastic Leukemia: Biology, Cytogenetics and Molecular Markers in Diagnosis and Prognosis: Poster II
Presentation time: Sunday, December 7, 2014, 6:00-8:00 p.m. PT
Location: North Building, Hall E (Moscone Center)

  • Abstract #2391: Minimal Residual Disease Detection Using High-Throughput Sequencing Predicts Clinical Outcome in Patients with Pediatric B-Lineage Acute Lymphoblastic Leukemia

Session: CLL: Biology and Pathophysiology, excluding Therapy: Poster II
Presentation time: Sunday, December 7, 2014, 6:00-8:00 p.m. PT
Location: West Building, Level 1 (Moscone Center)

  • Abstract #3302: Next-Generation Sequencing Reveals Clonal Evolution at the Immunoglobulin Loci in Chronic Lymphocytic Leukemia

Session: Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster III
Presentation time: Monday, December 8, 2014, 6:00-8:00 p.m. PT
Location: North Building, Hall E (Moscone Center)

  • Abstract #3961: Sequencing-Based Detection of Minimal Residual Disease Is Associated with Outcomes after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with Lymphoid Malignancies

Session: Myeloma: Therapy, excluding Transplantation: Poster III
Presentation time: Monday, December 8, 6:00-8:00 p.m. PT
Location: West Building, Level 1 (Moscone Center)

  • Abstract #4746: Carfilzomib, Lenalidomide, and Dexamethasone in High-Risk Smoldering Multiple Myeloma: Final Results from the NCI Phase 2 Pilot Study

MRD refers to cancer cells that remain in the body of a person with blood cancer after treatment and are undetectable by traditional microscopic examination of blood, bone marrow or lymph node biopsy. Very low levels of MRD can be reliably detected only by using sensitive molecular technologies, such as the next-generation sequencing based ClonoSIGHT process.

The ClonoSIGHT process has been clinically validated in five indications, including diffuse large b-cell lymphoma (DLBCL), multiple myeloma (MM), chronic lymphocytic leukemia (CLL), acute lymphoblastic leukemia (ALL) and mantle cell lymphoma (MCL).

About the ClonoSIGHT™ Process


Sequenta’s ClonoSIGHT process enables physicians to utilize sequencing-based minimal residual disease (MRD) detection as a clinical decision-making tool for patients with lymphoid cancers (blood cancers). Clinical validation studies have shown that this process, which utilizes Sequenta’s LymphoSIGHT™ platform, offers significant improvements in sensitivity and performance over other MRD detection methods.

MRD detection and quantification using the ClonoSIGHT process involves two steps that are easily integrated into patient care. In the first step, the ClonoSIGHT ID test, cancer cell DNA sequences are identified in a diagnostic sample. In the second step, the ClonoSIGHT MRD test, follow-up samples are screened for the previously identified sequences in order to detect residual disease. ClonoSIGHT test results are generated in seven days using Sequenta’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. For more information, please visit clonosight.com.

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™ process. 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 Sequenta
Sequenta is a 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 venture funding from Mohr Davidow Ventures, Index Ventures and Foresite Capital. For more information, please visitsequenta.com.

SOURCE: Sequenta

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