• Each year in the United States more than 55 million Pap smears are performed, of which 3.5 million have abnormal or unclear results[1]
  • The FHACT® test will be available immediately through CGI’s expanded National Clinical Sales Force

RUTHERFORD, N.J., October 28, 2015 — Cancer Genetics, Inc. (Nasdaq:CGIX; “CGI” or “the Company”), an emerging leader in DNA-based cancer diagnostics, announced that it has received a third U.S. patent covering FHACT® (U.S. Patent No. 9,157,129), its proprietary FISH (fluorescent in situ hybridization)-based HPV-Associated Cancer Test. FHACT® is primarily used as a diagnostic tool for the detection of cervical cancer and pre-cancers. This patent is part of a series of patents received for FHACT® that provide protections for CGI’s proprietary capabilities for the detection of HPV-associated cancers, which include cervical, anal, head and neck, penile, and vulvar cancers. Cervical cancer is one of the most common HPV-associated cancers, with approximately 528,000 new cases diagnosed annually worldwide.[2]

FHACT® uses DNA FISH-probes in the evaluation of biomarkers indicative of HPV-associated cancers in cervical or other cytology specimens. The results provided by the test have the potential to not only improve the clinical management of HPV-positive patients, but also to reduce costs of treatment for patients with abnormal cytology or positive HPV results.

The Company recently illustrated the clinical utility and sensitivity of the FHACT® test when it presented the results of two clinical studies at the HPV2015 conference in Lisbon, Portugal. In the first study, which was conducted with the National Cancer Institute (NCI) on 296 patients, the FHACT® test demonstrated 96.9% sensitivity. In the second study, which included 200 women, conducted in partnership with Kamineni Hospitals in Hyderabad, India, the FHACT® test was used in conjunction with molecular detection of HPV and demonstrated 94% sensitivity and specificity.

“Having a total of three patents directed to separate proprietary aspects of our unique FHACT® test. Having three patents for FHACT® further strengthens our position in this important and underserved category, and highlights the test’s unique ability to advance HPV-associated cancer detection and patient management,” said Panna Sharma, CEO of Cancer Genetics, Inc. “The test has benefits that are important for both patients and providers as FHACT® has the ability to repurpose patient samples to avoid additional invasive, time consuming, and costly procedures while also offering high-sensitivity genomic testing with robust performance.”

CGI received its first product design patent (US Patent No. 8,865,882) for the test’s unique four-probe combination on October 21, 2014. A second patent (US Patent No. 8,883,414) was granted on November 11, 2014 covering the test’s use on clinical patient samples, including cervical tissue specimens, remnant Pap-smear fluid, and liquid based cytology. The third patent covers the test’s method of analysis for results indicative of HPV-associated cancers or pre-cancers, which enable the appropriate management and triage of HPV-positive patients for treatment.

CGI’s FHACT® test accelerates the detection of cancers and precancerous lesions in HPV-positive patients and supports the efficient management of these diseases in an unprecedented way. The award of a third patent further demonstrates the uniqueness of FHACT® and strengthens CGI’s position as a leader in the HPV-associated cancer diagnostics market. The FHACT® test will be made available through CGI’s national clinical sales force.

To learn more about FHACT®, please visit http://www.cgifhact.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 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.

For more information, please visit or follow us:

Internet: http://www.cancergenetics.com

Twitter: @Cancer_Genetics

Facebook: www.facebook.com/CancerGenetics

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 Form 10-K for the year ended December 31, 2014 and 10-Q for the quarter ended June 30, 2015 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.

Media Relations Contact:
Marie Michellod, Ph.D.
Cancer Genetics, Inc.
1-201-776-1983
media@cgix.com

[1] 2012 Maternal and Family Health Services, Inc.
[2] 2014 World Cancer Research Fund International