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Cancer Genetics' Unique, Next Generation Sequencing Panel for Chronic Lymphocytic Leukemia (CLL) Selected for Use in Global Clinical Trial by Leading Biotechnology Company

  • CGI's unique next generation sequencing (NGS) panel, Focus::CLLTM, will be used to assess genetic aberrations and mutations that are clinically relevant and validated for CLL, the most common form of leukemia in the Western hemisphere.
  • CLL accounts for one-third of all leukemias and the Focus::CLLTM panel helps in determining patient outcome and treatment selection.

RUTHERFORD, N.J. and RESEARCH TRIANGLE, N.C., Feb. 17, 2015 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) ("CGI" or "the Company"), an emerging leader in DNA-based cancer diagnostics, announced today that its unique genomic panel for CLL, Focus::CLLTM, has been selected to provide genomic information for CLL patients in a global clinical trial. The trial is expected to assess several hundred patient specimens during 2015. Focus::CLLTM will be used to help guide patient stratification and management during the trial. The NGS-based panel is the only clinically validated, disease-focused genomic panel being offered in a commercial clinical setting for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). Focus::CLLTM is approved for clinical use by the Clinical Laboratory Improvement Amendments (CLIA).

The Focus::CLLTM panel assesses genes with clinical relevance for prognosis, disease management, and treatment selection. The targeted NGS panel was designed to offer actionable and immediately relevant information for clinicians. With an analytical sensitivity of 5%, the test is able to detect biomarker mutations and aberrations that are present at very low levels and which may be missed by other, less sensitive methodologies. Improved sensitivity can lead to enhanced diagnostic and prognostic capabilities for this disease and improved patient outcomes. In addition to being available as an individual test, Focus::CLLTM has been integrated into the company's CompleteTM offering for CLL/SLL.

"Our highly focused and custom NGS panel for CLL affords excellent depth of detection of variants in genes of high prognostic value in CLL patients," said Jane Houldsworth, Ph.D., Vice President of Research and Development at CGI. "For the first time, comprehensive, robust mutation analysis down to at least 5% sensitivity of genes such as TP53, NOTCH1, SF3B1, and uniquely ATM and BIRC3 are being offered in a clinically-regulated setting with results made available to clinicians in a streamlined and informative report to assist in the management of CLL patients."

CGI's Focus::CLLTM allows for rapid and highly sensitive sequencing of clinically validated genomic aberrations associated with CLL. The global clinical trial builds upon CGI's focus on hematological malignancies, and its goal of helping to empower the personalized treatment and management of cancer patients.

"CGI is developing a series of focused, clinically actionable NGS panels that will help deliver actionable information to help patients and clinicians both in routine treatment and in clinical trials," said Panna Sharma, CEO and President of CGI. "We have seen the need by both payers and biopharma companies to have more targeted, clinically actionable information delivered to influence and guide personalization in an era of targeted, pathway specific therapeutics. Our strategy is to continue developing unique, disease-focused NGS panels that can accelerate the adoption of biomarker driven personalization for cancer patients, aid clinicians and cancer centers, and power clinical trials."

Chronic lymphocytic leukemia accounts for roughly one-third of all newly diagnosed cases of leukemia, with about 15,700 cases diagnosed in the US each year. Due to disease's clinical heterogeneity, risk stratification and prognostication is especially important for patient selection in CLL trials.

The company also offers its proprietary MatBA® tests for diffuse large B-cell lymphoma (DLBCL), CLL, follicular lymphoma (FL), and mantle cell lymphoma (MCL) as part of its comprehensive testing for blood-borne cancers.

About Cancer Genetics

Cancer Genetics, Inc. 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 labs are focused entirely on maintaining clinical excellence and are both CLIA certified and CAP accredited and have 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, Columbia University and the National Cancer Institute.

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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 September 30, 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.

CONTACT: Media Relations Alison Burchett Cancer Genetics, Inc. 201-528-2053 alison.burchett@cgix.com Investor Relations Hans Vitzthum LifeSci Advisors, LLC 212-915-2568Source:Cancer Genetics, Inc.