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TMCNet:  Sequenta's ClonoSIGHT MRD Test Can Detect Relapse of Diffuse Large B-Cell Lymphoma More Than Seven Months Before CT Scan

[December 07, 2013]

Sequenta's ClonoSIGHT MRD Test Can Detect Relapse of Diffuse Large B-Cell Lymphoma More Than Seven Months Before CT Scan

NEW ORLEANS --(Business Wire)--

Sequenta, Inc. today announced that researchers from the National Cancer Institute (NCI) will present data showing that in the first five years post-treatment, the company's sequencing-based minimal residual disease (MRD) assay can detect relapse of diffuse large B-cell lymphoma (DLBCL) a median of 7.4 months prior to when the disease is detected via CT scan. Sequenta's recent announcement of the commercial launch of the ClonoSIGHT test for use in DLBCL patients is based on this clinical validation data, which will be presented at the 55th annual meeting of the American Society of Hematology (ASH).

Monitoring and relapse detection in DLBCL have traditionally relied upon CT and PET imaging, which are hindered by radiation exposure, high cost, high false positive rates and low sensitivity. Previously published research showed that Sequenta's assay can detect DNA from cancer cells in the blood of DLBCL patients by virtue of its high level of sensitivity. Researchers have now shown that this technology provides increased prognostic value.

"Sensitive MRD detection, as is possible with the ClonoSIGHT test, has the potential to reduce the cost, inconvenience and toxicity of imaging-based surveillance in DLBCL patients," said Wyndham Wilson, M.D., Ph.D., Head, Lymphoma Therapeutics Section, NCI. "Early detection of recurrence will significantly improve patient care."

Sequenta's assay demonstrated 80 percent sensitivity and 100 percent specificity in predicting relapse in patients who had achieved a complete response (CR) after treatment. Importantly, blood samples were consistently positive before the disease was detectable by CT (median 7.4 months; Abstract #1767: DNA Sequencing-Based Monitoring Of Serum Predicts Clinical Relapse Before CT Imaging In Diffuse Large B-Cell Lymphoma; Saturday, December 7, 5:30-7:30 p.m. CT; Hall G).

"These data validate the use of the ClonoSIGHT test for surveillance monitoring in DLBCL patients who have achieved remission and show that Sequenta's technology offers a major improvement over standard imaging techniques," said Tom Willis, CEO of Sequenta. "With the current imaging-based paradigm, patients who are cured by their initial treatment are being subjected to years of unnecessary scans, while patients bound for relapse are often not being identified until symptoms occur."

The study analyzed samples from 80 previously untreated DLBCL patients who received DA-EPOCH therapy with or without rituximab. Ten of the patients eventually progressed after initially achieving CR.

Additional data demonstrating the utility of the ClonoSIGHT test for MRD detection in DLBCL will be presented by Sequenta collaborators at ASH, as will data showing that the ClonoSIGHT MRD test can be used in follicular lymphoma and classical Hodgkin lymphoma.

  • Abstract #1785: Minimal Residual Disease Measurement By Deep Sequencing Reflects Changes In Disease Load During Therapy In Diffuse Large B Cell Lymphoma Patients (Poster; Saturday, 5:30-7:30 p.m.)
  • Abstract #4264: Utility Of Non-Invasive Monitoring Of Circulating Tumor DNA At Diagnosis, Interim Therapy, and Relapse Of DLBCL Using High-Throughput Sequencing Of Immunoglobulin Genes (Poster; Monday, 6:00-8:00 p.m.)
  • Abstract #4293: A Comparative Analysis Of Next-Generation Sequencing and Real-Time Quantitative PCR (News - Alert) For Minimal Residual Disease Detection In Follicular Lymphomas (Poster; Monday, 6:00-8:00 p.m.)
  • Abstract #627: Detection Of Classical Hodgkin Lymphoma In Peripheral Blood Using High-Throughput Sequencing Assay (Oral; Monday, 5:00 p.m., Room 243-245)


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 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 Lymphoma

Lymphomas are blood cancers that develop in the lymphatic system. There are two main types of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Hodgkin lymphoma is most common in adults, with only about 10-15 percent of cases occurring in children or teenagers. According to the American Cancer Society, an estimated 9,290 people in the United States will be diagnosed with Hodgkin lymphoma in 2013 and 1,180 will die from the disease. NHL also 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.

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. It affects mostly middle-aged and older adults.

About Follicular Lymphoma

Follicular lymphoma, which derives its name from the circular pattern in which it tends to grow in lymph nodes, accounts for about 20 percent of all lymphomas in the United States. The average age for people with this lymphoma is about 60.

About Classic Hodgkin Lymphoma

Classic Hodgkin lymphoma, which accounts for about 95 percent of all cases of Hodgkin lymphoma in developed countries, is one of the most curable forms of cancer. It comprises four subtypes (nodular sclerosis, mixed cellularity, lymphocyte-rich and lymphocyte-depleted), which are all characterized by the presence of classic-looking Reed Sternberg cells. The other five percent of Hodgkin lymphomas are of the nodular lymphocyte-predominant type.

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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