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Cancer Genetics, Inc. Announces Focus::Myeloid(TM) - A Comprehensive Next-Generation Sequencing Based Genomic Panel for the Improved Diagnosis, Prognosis and Clinical Management of Myeloid Cancer Patients

  • Focus::Myeloid™ will help clinicians and cancer centers improve the management and treatment of more than 275,000 patients in the U.S. currently living with myeloid malignancies
  • Over 100 clinical studies are being conducted by biotechnology and pharmaceutical companies for compounds targeting myeloid cancers that can potentially benefit from CGI's Focus::Myeloid™ and improvements to enrollment, stratification and treatment monitoring

RUTHERFORD, N.J., April 30, 2015 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) ("CGI" or the "Company"), a leader in DNA-based cancer diagnostics, announced the launch of Focus::Myeloid™, a next-generation sequencing (NGS) based panel for myeloid cancers including acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and myeloproliferative neoplasms (MPN). The Focus::Myeloid™ panel will be performed in CGI's CLIA certified lab.

Focus::Myeloid™ is designed by a consortium of recognized experts in blood cancer disorders. Utilizing NGS technology pioneered by Illumina, a global leader in next-generation sequencing technologies, the panel assesses 54 genes with clinical relevance for the diagnosis, prognosis, and management of myeloid cancers. Sanger sequencing is performed to assess abnormalities in several additional genes to provide a precise evaluation of the genetic profile of each patient's cancer. Focus::Myeloid™ is available as an individual test and as part of the company's Complete™ programs for AML, MDS, and MPN, which offer a comprehensive assessment of the molecular genetics of the cancer along with pathology and morphological information.

"We are certain the information that Focus::Myeloid™ offers clinicians will allow them to make better-informed, genomically-guided decisions that are aligned with guidelines, and best practices. This is the type of insight that can result in more effective management of patients with myeloid cancers," said Lan Wang, MD, Medical Director of Cancer Genetics.

There are roughly 54,000 newly diagnosed cases of myeloid cancers in the U.S. each year - 19,000 cases of AML, 15,000 cases of MDS, and 20,000 cases of MPN. Current methods for diagnosis and patient stratification are time-consuming and expensive, requiring multiple tests for different genetic mutations. Focus::Myeloid™ delivers comprehensive genomic assessment in a single test for accurate, economical, and rapid profiling of the patient's tumor. Genetic biomarkers such as NPM1, FLT3, JAK2, KIT, and TP53 associated with these myeloid malignancies have been incorporated into clinical guidelines for diagnosis and risk assessment. In addition, CGI's Focus::Myeloid™ panel includes within the 54-gene panel, newly discovered biomarkers that have shown significance in clinical studies and therapeutic selection.

"We currently lack sophisticated or comprehensive tools to diagnose and manage MDS in the clinical and community setting. Additionally, MDS is not easily diagnosed and is a complex disease, which can have many variables. There is tremendous need for new diagnostic tools that provide information to improve patient management. Having preliminary data from a NGS panel would be incredibly helpful in determining a definitive diagnosis, establishing treatment options, and can potentially help forecast the development of a patient's disease," said Dr. Shabbir Safdar, MD, of University Hematology Oncology in St. Louis, MO.

Focus::Myeloid™ is also being offered to biopharmaceutical companies as part of CGI's clinical trials services. There are currently over 100 open clinical trials enrolling more than 9,000 patients with AML, MDS, and MPN. The Focus::Myeloid™ Panel from Cancer Genetics can not only help with clinical treatment options, but can also provide a rationale for patient enrollment in specific trials to highlight the effectiveness of the drug being tested. Genomics-assisted patient selection can improve the effectiveness and reduce the overall cost of clinical trials.

Cancer Genetics' first disease-specific NGS panel, Focus::CLL™ for chronic lymphocytic leukemia, was launched in December 2014. The company is actively developing a pipeline of NGS panels targeting a variety of cancers, including hematological cancers and solid tumors through its internal innovation efforts. In addition, CGI expects to launch NGS panels that are currently in development through OncoSpire Genomics, its joint venture with Mayo Clinic.

For more information, please visit www.cancergenetics.com.

About Cancer Genetics:

Cancer Genetics Inc. is an emerging leader in DNA-based cancer diagnostics. Our tests target difficult to diagnose hematological, urogenital and HPV-associated cancers. They are designed to guide the prognosis and treatment of these cancers with the goal of improving outcomes for patients. We have established strong clinical research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute.

We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals and biopharmaceutical companies. Our state-of-the-art reference labs are CLIA certified and CAP accredited in the US and have licensure from several states including New York State.

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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 developments in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. tests 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, 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, 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 Marie Patron-Agnes Michellod, Ph.D. Cancer Genetics, Inc. 201-528-9200 media@cgix.com Investor Relations Hans Vitzthum LifeSci Advisors, LLC. 212-915-2568 hans@lifesciadvisors.com

Source:Cancer Genetics, Inc.