RUTHERFORD, N.J., Sept. 2, 2014 (GLOBE NEWSWIRE) -- – Cancer Genetics, Inc. (Nasdaq:CGIX) (“CGI” or “The Company”), an emerging leader in DNA-based cancer diagnostics, announced today that their proprietary DNA-probe based test for cervical cancer (FHACT®) has received the CE Marking.
The Conformité Européenne (CE) mark is a conformity mark required to market in vitro diagnostic medical devices in the European Economic Area (EEA). The CE marking indicates the test’s compliance with European Union (EU) product safety legislation and allows FHACT® to be sold freely within the European Economic Area (EEA), which includes the 28 member states of the EU as well as the European Free Trade Association.
Each year, nearly 34,000 new cases of cervical cancer are diagnosed in the EEA. While screening protocols are relatively well established within Europe, there remains a significant need for a supplement to current screening methods that can better predict progression to advanced cervical disease. Cancer Genetics’ proprietary FHACT® test, which can identify irreversible genomic changes associated with progression to cancer, adds predictive value to this screening protocol. In addition to identifying those women most at risk for cervical disease, it can help reduce unnecessary, invasive testing and over-treatment in women who do not show the genomic abnormalities associated with disease progression.
“We are enthusiastic that FHACT® is now CE marked. The CE marking supports the adoption of the FHACT® probe in the clinical setting, and we are confident that the test will help better identify women who need further follow up after initial screening,” said Giovanni Babini, Marketing and Business Development Manager for Technogenetics, SRL, a Bouty Company.
“We are committed to the highest level of quality in the development and manufacture of our DNA-FISH probes and tests. Our probes are manufactured to meet or exceed all established quality and performance specifications, and comply with relevant safety and regulatory requirements in order to qualify them for CE marking,” said Panna Sharma, CEO of Cancer Genetics, Inc. “Cervical cancer screening is evolving, but there remains a need for more definitive and genomically informed diagnosis. Our proprietary cervical cancer test, FHACT®, was designed in response to this need. Having it affixed with the CE mark will allow us to expand our marketing and sales in Europe, and allow for greater adoption of the test globally.” ?
The marking of FHACT® with the CE stamp is one of a number of initiatives currently being employed by Cancer Genetics to empower widespread access to FHACT® for cervical cancer screening. Cancer Genetics continues to market the test to clinicians and pathology labs in North America, India and Asia. FHACT® was recently featured as an innovative product in a video series on Product Pioneers, put on by ClinicalOMICs, a Mary Ann Liebert, Inc. company. The video is accessible at https://www.youtube.com/watch?v=CXwcvbmZVzw. More information about FHACT® can also be found at www.cgifhact.com. The FHACT® probe is manufactured and distributed by CGI Italia, a wholly owned subsidiary of Cancer Genetics, Inc.
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 further information, please see http://www.cancergenetics.com.
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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