News | May 15, 2014

Study Shows Sequenta's Sequencing-Based Minimal Residual Disease (MRD) Detection Technology Has Prognostic Value In Multiple Myeloma

SOUTH SAN FRANCISCO, CALIF.--(BUSINESS WIRE)--

Sequenta, Inc. today announced publication of a study demonstrating that the company’s ultra-sensitive sequencing-based minimal residual disease (MRD) detection technology, available clinically as the ClonoSIGHT™ test, provides important prognostic information in multiple myeloma. Both time to progression (TTP) and overall survival (OS) were shown to be significantly longer in MRD-negative patients compared those who were MRD-positive (n=110; median TTP: 80 months vs. 31 months, p<0.0001; median OS: not reached vs. 81 months, p=0.02).

“Most patients with multiple myeloma will unfortunately relapse and succumb to their disease despite initially achieving remission, usually due to the persistence of minimal residual disease that is undetectable using current methods,” said Joaquin Martínez-López, M.D., Head of Hematology, Hospital Doce de Octubre, Madrid, Spain. “Better assessment of treatment response, prediction of long-term outcomes and evaluation of the comparative efficacy of novel therapies requires that a sensitive MRD detection technology like Sequenta’s be integrated into myeloma care and clinical trials.”

Remission in multiple myeloma is traditionally assessed via examination of the bone marrow and tests of the serum and urine to detect a protein characteristic of the disease called M protein. In the current study, 62 of 110 evaluable patients met the conventional criteria for complete remission (CR). However, when analyzed with Sequenta’s MRD detection technology, two distinct groups with significantly different TTP were identified. Those determined to be MRD-negative (no evidence of myeloma detectable at or below the level of one in 100,000 total white blood cells) lived for a median of eight years longer without their disease progressing than those who were MRD-positive (median TTP: 131 months vs. 35 months, p=0.0009).

“The long-term survival of myeloma patients with the very deepest levels of response to treatment shows how close we are getting to curing this disease in some cases,” said Ramón García-Sanz, M.D., Ph.D., senior author of the study. “It is critical that MRD detection methods with high sensitivity be integrated into the care of myeloma patients so that we can measure our progress and continue to improve outcomes.”

“This study shows that the ClonoSIGHT test is a useful tool for patient risk stratification, which can be used by a physician to determine the best course of treatment for an individual patient,” said Tom Willis, CEO of Sequenta. “Most importantly, we have shown that among patients considered to be in complete remission, our ultra-sensitive next-generation sequencing-based technology identifies patients with detectable disease who are at greater risk of progression and may benefit from additional therapy.”

The study, “Prognostic value of deep sequencing method for minimal residual disease detection in multiple myeloma,” by Martínez-López, et al., was published today in the May 15 issue of Blood.

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 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, about 24,050 people in the United States will be diagnosed with MM in 2014 and an estimated 11,090 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.


Copyright Business Wire 2014

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