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Only NGS-based panel for CLL that offers information for patient risk stratification, disease management, and treatment selection
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Focus::CLL addresses a significant market of over 120,000 patients in the US living with CLL, the most common form of leukemia in the Western hemisphere
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Focus::CLL is available for both routine patient diagnosis and management as well as clinical trials for CLL
RUTHERFORD, N.J., Dec. 8, 2014 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) ("CGI" or the "Company"), an emerging leader in DNA-based cancer diagnostics, announced today it has been licensed by the Clinical Laboratory Improvement Amendments (CLIA) to perform Focus::CLL™, the company's unique next-generation sequencing (NGS)-based panel for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
The panel assesses seven 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::CLL will be integrated into the company's CompleteTM offering for CLL/SLL.
CLL accounts for roughly one-third of all newly diagnosed leukemia cases. Over 15,000 new cases are diagnosed in the US each year, and an estimated 120,000 individuals are currently living with the disease. Recent advances in treatment for CLL have been significant, including the July 2014 FDA approval of idelalisib and ibrutinib for the disease, but due to tumor heterogeneity, precisely prognosing CLL has remained a challenge. Focus::CLL responds to this challenge by providing a comprehensive view of the tumor's genomic profile, detecting mutations with relevance for prognosis and treatment selection. Focus::CLL is the only NGS panel that assesses these seven biomarkers with a single test.
"With the recent development of NGS technology, a growing number of molecular prognostic markers have been identified in CLL patients. The Focus::NGS panel for CLL provides us a comprehensive and targeted platform to identify mutations with prognostic significance from multiple genes simultaneously, and provide information that assists clinicians in making management decision for CLL patients," said Weiyi Chen, Ph.D., Director of Cancer Genetics' molecular diagnostic laboratory. "NGS-based sequencing increases the sensitivity to identify low-frequency mutations, allowing us to sequence the genes more quickly and more comprehensively."
In addition to being offered for clinical use, the NGS-based panel will be available through the company's Select One® clinical trials offering, which provides clinical trial support to biotech and pharma companies engaged in oncology trials. CGI has been instrumental in a number of CLL trials, and the company anticipates that Focus::CLL™ will have significant utility and value for clinical trials.
"Clinicians and researchers are demanding actionable and targeted information for improving the management and insight into their CLL patients' disease," said Panna Sharma, CEO and President of Cancer Genetics. "The launch of this targeted NGS panel to improve the precision of diagnosis and prognosis is a critical step towards improving the linkage between novel, targeted therapeutics and patient groups in CLL."
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 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.
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