• Study will correlate genetic markers to outcome in ~200 patients with diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin lymphoma.
  • Additional genetic markers validated in the study will be incorporated into CGI's proprietary test and genetic signature for the prediction of outcome in DLBCL.

RUTHERFORD, N.J., Sept. 23, 2014 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) ("CGI" or "The Company"), an emerging leader in DNA-based cancer diagnostics, and Beth Israel Deaconess Medical Center, announced today that they have entered into a collaboration to examine genomic biomarkers in patients with Diffuse Large B-Cell Lymphoma (DLBCL), and use an integrated approach to investigate their association with patient outcome.

Approximately 200 DLBCL tumors from patients previously treated with current frontline immunotherapeutic regimens (eg., Rituximab) will be evaluated. The biomarkers assessed will include genomic rearrangements, copy number changes, and mutations. Copy number changes will be detected by CGI's proprietary MatBA® array, which is commercially available as a laboratory developed test and is CLIA and NYS approved. Mutation analysis of a panel of genes known to be altered in DLBCL will be performed by next-generation sequencing (NGS). By looking at these patient samples and assessing the relationship of shared genetic variants to overall survival, the study will allow researchers to assess the genomic landscape of DLBCL tumors and integrate knowledge of shared genomic alterations into a robust, clinically validated model of DLBCL patient survival and outcome. Genomic variants with prognostic value validated in prior studies performed by CGI and in this collaboration will be integrated into CGI's CompleteSM program for DLBCL, offering improved value for patients, doctors, and the biopharma community.

"CGI's collaboration with Beth Israel Deaconess Medical Center reiterates our commitment to providing best-in-class prognostic and diagnostic tests for hematological cancers. We recognize the significant ongoing need for genomic prognostic markers in these cancers, in particular DLBCL, and are proud to be at the forefront of personalized medicine for hematological oncology," said Panna Sharma, CEO of Cancer Genetics, Inc.

DLBCL is the most common type of aggressive non-Hodgkin Lymphoma, accounting for approximately 40% of all B-cell malignancies. An estimated 190,000 people in the United States are currently living with, or are in remission from, DLBCL, and approximately 20,000 new cases are diagnosed each year. Prognosis and outcome prediction for these patients is difficult, and is currently based primarily on clinical features and few molecular markers. To date, a number of studies have reported the relationship of individual molecular markers to prognosis, but the relationship of these individual markers to one another has not been adequately examined or built into a comprehensive model. The collaboration between Cancer Genetics and Beth Israel Deaconess Medical Center will allow researchers to determine the relationship of these genomic biomarkers to one another and their collective impact on DLBCL patient overall survival.

The addition of robust molecular markers to assist in predicting patient outcome will improve patient stratification and prognostication in DLBCL, and will better identify those patients likely to have an overall good prognosis, versus those who are likely to relapse or who are not likely to respond to treatment. Improved DLBCL prognostication will allow clinicians to implement more personalized, risk-adapted treatment options for their patients, and better inform patient monitoring.

The company's collaboration with Beth Israel Deaconess Medical Center is one of a number of research partnerships in which the company is currently engaged. Cancer Genetics, Inc. believes that their improved proprietary diagnostic and prognostic panels will continue to prove beneficial for cancer patients, as well as clinical trial customers and sponsors. A number of advancements in the treatment of hematological cancers have recently been made, and there are currently more than 1500 clinical trials in phase II and III for B-cell malignancies. As the number of these trials continues to increase, CGI expects an increasing demand for their proprietary MatBA ® test for B-cell neoplasms.

About Beth Israel Deaconess Medical Center

Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School, and currently ranks third in National Institutes of Health funding among independent hospitals nationwide.

BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, Signature Health Care, Beth Israel Deaconess HealthCare, Community Care Alliance, and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Senior Life and is a research partner of Dana-Farber/Harvard Cancer Center. BIDMC is the official hospital of the Boston Red Sox. For more information, visit www.bidmc.org.

About Cancer Genetics

Cancer Genetics Inc. (Nasdaq:CGIX) is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital, and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference lab is focused entirely on maintaining clinical excellence and is both CLIA certified and CAP accredited and has licensure from several states including New York State. We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

For more information, please visit www.CancerGenetics.com, or follow Cancer Genetics on twitter @Cancer_Genetics.

Forward Looking Statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, risks that the transaction will not close or, if it closes, will not realize the currently anticipated benefits, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Company's Form 10-K for the year ended December 31, 2013 and 10-Q for the quarter ended March 31, 2014 along with other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics disclaims any obligation to update these forward-looking statements.
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