|[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
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
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.
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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