Cancer Genetics, Inc. receives regulatory approvals for MatBA®-DLBCL, a proprietary microarray test for the diagnosis, prognosis, and patient risk stratification of non-Hodgkin lymphoma

  • MatBA® -DLBCL is designed to assist in the clinical management of diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma
  • Test was developed at Cancer Genetics, Inc. and clinically validated in collaboration with Memorial Sloan-Kettering Cancer Center
  • Regulatory approval expands CGI’s menu of CLIA- & New York State-approved molecular diagnostics for hematological, urogenital, and gynecological cancers

Rutherford, February 25, 2013 — Cancer Genetics, Inc. (CGI), a leader in oncology-focused personalized medicine, today announced it has received CLIA and New York State approvals for clinical use of its proprietary mature B-cell neoplasm array or MatBA®  (patent 13/475,034) for diffuse large B-cell lymphoma. MatBA®-DLBCL will assist clinicians in the diagnosis and prognosis of DLBCL.

DLBCL is the most common form of non-Hodgkin lymphoma (NHL), a diverse group of hematological malignancies. An estimated 190,000 people in the United State suffer from DLBCL, and up to 24,500 new U.S. cases diagnosed each year, which accounts for up to 40% of all NHL cases. Newly-diagnosed patients have a median age of 64 years, and disease progression and outcomes vary widely, due in part to the genomic characteristics of each individual patient’s cancer. This creates a strong clinical need for accurate and molecularly-informed prognostic testing both at the time of initial diagnosis and throughout ongoing disease monitoring efforts to ensure selection of the best treatment plan for an individual patient. However, current prognostic modalities rely primarily on clinical features.

CGI’s MatBA®-DLBCL microarray provides clinicians with information on genomic alterations in DLBCL, including regions of gain and loss that are associated with disease outcome.

A research collaboration between the Memorial Sloan-Kettering Cancer Center and CGI using 87 patient samples, as well as the analysis of two open datasets including 171 samples (GSE11318, Lenz et al.) and 51 high risk samples (E-MEXP-3463, Taskinen) and other published datasets showed that:

  •      MatBA®-DLBCL has both diagnostic and prognostic value
  •      MatBA®-DLBCL can assist in patient stratification for risk-adapted therapy when performed at diagnosis
  •      MatBA®-DLBCL assesses the presence of single biomarkers as well as genome complexity as measures of overall survival following front-line immunochemotherapy

CGI believes that it is the only laboratory to have a CLIA and New York State approved microarray for the genomic assessment of DLBCL. The MatBA® -DLBCL Array CGH assay joins the DLBCL CompleteSM program offered by CGI, which includes a suite of esoteric tests used in the diagnosis, prognosis and clinical management of DLBCL patients.  This newly-approved DLBCL test extends CGI’s ongoing commitment to developing new diagnostic and disease management tools for some of the most costly and critical unmet needs in oncology today. MatBA® -DLBCL joins MatBA® -CLL (chronic lymphocytic leukemia) and MatBA® -SLL (small lymphocytic lymphoma) in CGI’s suite of CLIA- and New York State-approved proprietary microarrays for the clinical management of underserved hematological malignancies.

About Cancer Genetics, Inc.

Cancer Genetics, Inc. (CGI) is an emerging leader in the field of personalized medicine, offering products and services that enable cancer diagnostics as well as treatments that are tailored to the specific genetic profile of the individual. CGI is committed to maintaining the standard of clinical excellence through its investment in outstanding facilities and equipment. Our reference laboratory is both CLIA certified and CAP accredited. In addition, we have approvals and accreditations from the states of Florida, Maryland, New York, and New Jersey. The company has been built on a foundation of world-class scientific knowledge and IP in solid and hematologic cancers, as well as strong research collaborations with major cancer centers such as Memorial Sloan-Kettering and the National Cancer Institute.

CGI’s dedicated staff takes pride in our specialized laboratory services, superior turnaround time (TAT), enhanced reporting, EMR integration, and ongoing research and development for new oncology tests. CGI’s full-service cancer genetic practice and path to innovation with research makes for optimal patient care management. For further information, please see www.cancergenetics.com.

 

For more information, contact:

Marie-Agnès Patrone-Michellod, PhD. | Marketing and Regulatory Affairs Manager

Phone: (201) 528 9182 | Email: mmichellod@cancergenetics.com