Sequenta and Collaborators to Present New ClonoSIGHT™ Test Data at Annual Meeting of the American Society of Hematology

November 7, 2013

Seventeen presentations cover a variety of blood cancers, including multiple myeloma, diffuse large B-cell lymphoma and acute lymphoblastic leukemia 

Sequenta, Inc., and its collaborators from academic institutions around the world will share data demonstrating the validity and prognostic value of the ClonoSIGHT test for minimal residual disease (MRD) in four oral and 13 poster presentations, encompassing eight different blood cancer subtypes, at the annual meeting of the American Society of Hematology (ASH) being held December 7-10, 2013 in New Orleans, La.

The ClonoSIGHT test is the first clinically actionable sequencing-based test for 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 results provide important information about patient prognosis and can be used to help guide treatment decisions. 

“The extensive and high-quality research being presented by Sequenta and our collaborators at ASH this year is a reflection of the company’s commitment to conducting rigorous clinical validation studies of the ClonoSIGHT test,” said Tom Willis, CEO of Sequenta. “We are dedicated to expanding this groundbreaking application of next-generation sequencing to MRD detection in all lymphoid cancers.”

The ClonoSIGHT test commercially launched in acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL) in February 2013. Continuing studies, including some being presented at ASH, are being used to clinically validate the test for use in other indications.

The schedule for Sequenta’s oral presentations is as follows:

Abstract #149: Alloreactive T Cell Clonotypes Identified By In Vitro Mixed Lymphoid Reaction and High-Throughput Sequencing Exhibit Increased Frequency In Peripheral Blood Samples From Patients Following Allogeneic Hematopoietic Cell Transplantation For Chronic Lymphocytic Leukemia
Presenter: Aaron Logan, MD, PhD (UCSF)
Session: Clinical Allogeneic Transplantation – Acute and Chronic GVHD, Immune Reconstitution: Biomarkers of GVHD and Immune Recovery 
Presentation time: Sunday, December 8, 2013, 6:00 p.m. CST
Location: Ernest N. Morial Convention Center, Riverside Rooms – R08-R09

Abstract #351: Next-Generation Sequencing and Real-Time Quantitative PCR For Quantification Of Low-Level Minimal Residual Disease In Acute Lymphoblastic Leukemia Of Adults
Presenter: Monika Brüggemann, MD, PhD (University of Kiel)
Session: Leukemias: Biology, Cytogenetics and Molecular Markers in Diagnosis and Prognosis: Next-Generation Sequencing and Gene-Expression Profiles in Acute Lymphoblastic Leukemia
Presentation time: Monday, December 9, 2013, 11:00 a.m. CST
Location: Ernest N. Morial Convention Center, 291-292

Abstract #401: Deep Sequencing Reveals Oligoclonality At The Immunoglobulin Locus In Multiple Myeloma Patients
Presenter: Nikhil Munshi, MD (Dana-Farber Cancer Institute)
Session: Myeloma: Biology and Pathophysiology, excluding Therapy: Clonal Evolution and Genomic Heterogeneity in Myeloma
Presentation time: Monday, December 9, 2013, 11:30 a.m. CST
Location: Ernest N. Morial Convention Center, 388-390

Abstract #627: Detection Of Classical Hodgkin Lymphoma In Peripheral Blood Using High-Throughput Sequencing Assay
Presenter: Yasuhiro Oki, MD (MD Anderson Cancer Center)
Session: Hodgkin Lymphoma: Biology, excluding Therapy: Genomics
Presentation time: Monday, December 9, 2013, 5:00 p.m. CST
Location: Ernest N. Morial Convention Center, 243-245


The schedule for Sequenta’s poster presentations is as follows:

Session: Leukemias: Biology, Cytogenetics and Molecular Markers in Diagnosis and Prognosis: Poster I
Presentation time: Saturday, December 7, 2013, 5:30-7:30 p.m. CST
Location: Ernest N. Morial Convention Center, Hall E


Session:
Non-Hodgkin Lymphoma: Biology, excluding Therapy: Poster I
Presentation time: Saturday, December 7, 2013, 5:30-7:30 p.m. CST
Location: Ernest N. Morial Convention Center, Hall G


Session:
Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models:Poster I
Presentation time: Saturday, December 7, 2013, 5:30-7:30 p.m. CST
Location: Ernest N. Morial Convention Center, Hall G


Session:
Myeloma: Biology and Pathophysiology, excluding Therapy: Poster I
Presentation time: Saturday, December 7, 2013, 5:30-7:30 p.m. CST
Location: Ernest N. Morial Convention Center, Hall G


Session: Leukemias: Biology, Cytogenetics and Molecular Markers in Diagnosis and Prognosis: Poster II

Presentation time: Sunday, December 8, 2013, 6:30-8:30 p.m. CST
Location: Ernest N. Morial Convention Center, Hall E


Session: Myeloma: Therapy, excluding Transplantation: Poster II
Presentation time: Sunday, December 8, 2013, 6:30-8:30 p.m. CST
Location: Ernest N. Morial Convention Center, Hall G


Session: Non-Hodgkin Lymphoma: Biology, excluding Therapy: Poster II
Presentation time: Monday, December 9, 2013, 6:00-8:00 p.m. CST
Location: Ernest N. Morial Convention Center, Hall G


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 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.