- The FHACT™ test is focused on earlier detection and enables genomic guided decision making and triaging of cervical cancer caused by HPV
- CGI worked on the research and development of this test based on a multi-year research grant with the National Cancer Institute and additional validations with global partners
- The test will be made available through partnerships and collaborations with regional laboratories, hospitals and women's health centers and supported by a HIPAA-compliant cloud-based portal, FHACT-NET™, which will aid in tracking usage, clinical and genomic outcomes and provide improved insight for community oncologists, pathologists and gynecologists.
RUTHERFORD, N.J., Nov. 18, 2013 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq: CGIX ) ("CGI" or the "Company"), an emerging leader in DNA-based diagnostics, announced that its proprietary DNA-based test for cervical cancer, FHACT™, has received regulatory approval from the Clinical Laboratory Improvement Amendments (CLIA) as a Laboratory Developed Test (LDT). The test will be made available to help in the triaging and decision-making associated with the roughly 3.5 million abnormal Pap smears in the U.S. each year in order to diagnose and manage cervical cancer. CGI's FHACT™ test provides genomic information directly from the abnormal Pap smear sample and does not require additional office visits.
With the recent CLIA approval, CGI will now provide the test domestically as well as in partnership with local OBGYN's, community hospitals and laboratories to better manage and inform the detection and staging of HPV-related cervical cancer. The test was launched in select countries outside the U.S. in June of 2013.
The FHACT™ test, which is for HPV-associated cancers, was developed by CGI and validated in a research collaboration with the National Cancer Institute (NCI). Data from the study has been published in the July issue of Gynecologic Oncology ( http://dx.doi.org/10.1016/j.ygyno.2013.06.005 ) and supports the use of FHACT™ as an aid in the screening of women with HPV-positive abnormal cervical lesions. CGI and NCI continue ongoing validations to support the test's utility in genomic validation and triaging of cervical cancer directly from a Pap smear.
With only 3,700 squamous cervical carcinoma cases diagnosed from the 2.5 million biopsies done each year in the U.S., there is a need to identify women who are at risk of developing cervical cancer with greater efficiency; reduce the health-care burden through a less invasive process; and improve the genomic accuracy of the diagnosis. FHACT's potential for more accurate and earlier detection of HPV-associated abnormalities can save valuable time in the testing process, while creating substantial cost savings for the healthcare system.
Nearly all cases of cervical cancer are caused by infection with oncogenic, or high-risk, types of human papillomavirus, or HPV. There are about 12 high-risk HPV types, and many of them are also closely associated with other HPV-related cancers. CGI has initiated studies to develop and refine its FHACT™ test for these additional indications as well.
In order to support the education, adoption and usage of FHACT™ and to improve the outcomes for patients, CGI is launching FHACT-NET™. FHACT-NET™ is a cloud-based, HIPAA-compliant database that will compile data from clinical sites performing FHACT™ tests and create a genomic knowledge-source based on curated information from de-identified specimens. Network participants will include both national and international laboratories, cancer centers and hospitals.
Panna Sharma, president and CEO, commented: "The validation of our test through the NCI study will be enhanced by the development of an active repository of crucial data from which we can continue to grow our understanding of HPV-associated cancers. The ultimate goal of this improved understanding is to commercialize tests that improve patient care by making data-driven refinements to our algorithm so that more accurate and more cost-effective diagnosis of HPV-associated cancers can be made."
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 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 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, 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-Q for the quarter ended March 31, 2013 and 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.
Investor Relations RedChip Companies, Inc. Jon Cunningham, 800-733-2447, ext. 107
