Cancer Genetics, Inc. Partners With Leading Southwest Gynecological Pathology Lab to Provide Great Availability of FHACT®, a Non-Invasive, Genomic Test to Guide the Detection and Management of Cervical Cancer

By Jamie on June 3 2014
  • Collaboration With PathAdvantage Introduces Precision Testing for Cervical Cancer Into The Rapidly Growing Metro Dallas and North Texas Market
  • PathAdvantge Will Incorporate the Genomic Test as Part of Its Comprehensive Focus on Gynecological Cancers

RUTHERFORD, N.J., June 3, 2014 (GLOBE NEWSWIRE) — Cancer Genetics, Inc. (Nasdaq:CGIX) a DNA-based diagnostics company focused on developing genomic-based oncology tests and services, announced today that it has entered into a multi-year agreement to collaborate and provide PathAdvantage Associated with Cancer Genetics’ proprietary FHACT®, a FISH-based genomic test for the detection and management of cervical cancer.

PathAdvantage delivers specialized, focused gynecological pathology services to the medical communities in the greater Dallas-Fort Worth area and surrounding markets as far north as the Oklahoma border. Their testing services provide minimally invasive biopsy and colposcopy techniques for both cervical and endocervical biopsy collection, as well as liquid based pap testing with high risk HPV testing.

“The FHACT test meets a significant unmet need in cervical cancer care,” said Panna Sharma, CEO of Cancer Genetics Inc. “Many women in the United States and around the world are undergoing invasive procedures that may be unnecessary, time-consuming and costly because no test has previously existed to identify the lesions that are likely to progress to cervical cancer. Our collaboration with PathAdvantage is an important step in making this test more widely available and we hope will provide a tremendous service in increasing timely diagnosis while potentially lowering costs.”

PathAdvantage is well positioned in one of the fastest growing regions in the country by having a multidisciplinary group of skilled, experienced and respected pathologists. In collaboration with clinicians, PathAdvantage helps create personalized treatment plans for patients in the Dallas Fort Worth metropolis which has a population of nearly 7 million people. CGI’s FHACT test will aim at improving and streamlining the treatment strategies for the women of North Texas who are high risk HPV positive and/or diagnosed with cervical dysplasia.

“We pride ourselves in being at the forefront of quality gynecologic pathology,” said Alexandra Gillespie M.D., Medical Director at PathAdvantage. “Our collaboration with Cancer Genetics on the FHACT test gives our clients and their patients an important edge in the management and treatment of HPV-related cervical cancers by identifying the high-risk, HPV-positive patient population that are likely to progress to severe dysplasia and beyond.”

PathAdvantage will work in collaboration with Cancer Genetics to extend research in support of the FHACT test by making samples available to further validate the test and support additional publications. The partnership will allow PathAdvantage to leverage Cancer Genetics’ expertise in gynecological cancers and support additional biomarker studies that may yield patient value.

The collaboration is part of CGI’s strategy of partnering with regional testing providers in order to commercialize the FHACT test. FHACT aims at advancing the paradigm of cervical cancer management by potentially enabling a greater level of precision in cancer diagnosis and treatment.

The introduction of the FHACT test aims at setting a new standard of care in testing for cervical cancer by distinguishing cervical lesions that may progress to cancer from those that may regress on their own. The FHACT test can be used in conjunction with a test for the Human Papillomavirus (HPV), a causative agent for cervical cancer, as well as with the traditional cytology based Pap test.

Of the 2.5 million cervical biopsies performed annually in the United States, only about 4,000 result in a diagnosis of squamous cervical carcinoma. The current HPV test does not identify which patients in the high-risk group are likely to develop cervical cancer; therefore the majority of patients are typically referred for colposcopy and biopsy procedures. By allowing clinicians to identify which HPV high-risk positive patients are likely to develop cancer, the FHACT test aims at improving diagnostic accuracy, and potentially saves on health care costs by eliminating unnecessary colposcopies and cervical biopsies.

The FHACT test is the only four-color FISH probe that can be used for cervical cancer screening as an additional diagnostic tool before referring patients for colposcopies. The test has the added advantage that it can be performed on the same sample used to perform the Pap or HPV test, meaning that it requires no return trip to a physician’s office or laboratory for the patient. The test, which was introduced in the United States in late November of 2013, was developed through a multi-year research grant with the National Cancer Institute.

FHACT is one of six targeted genomic tests that Cancer Genetics has developed to help physicians better diagnose and treat difficult-to-diagnose cancers by providing diagnostic, prognostic and theranositc information to personalize the clinical management of cancer. Cancer Genetics offers a comprehensive range of oncology-focused test and laboratory services, providing critical genomic information to healthcare professionals, cancer centers and biopharmaceutical companies. Additional information about the test can be found at, a website dedicated to the genomic test.

About Cancer Genetics, Inc.

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

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, 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 Forms 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.

CONTACT: Cancer Genetics, Inc.
         Marie-Agnes Patrone-Michellod, Ph.D.
         Marketing & Regulatory Affairs
         201.528.9200 (main)
         201.528.9182 (direct)

         Andrew McDonald
         LifeSci Advisors, LLC

         Public Relations
         Jerry Schranz
         Beckerman Public Relations