The test focused on the early detection and allows genomic-driven decision-making and grading of cervical cancer caused by HPV
- CGI worked on the research and development of this test, based on years of research with a grant from the National Cancer Institute and the additional checks with global partners
- The test will be distributed through partnership and collaboration with regional laboratories, hospitals and health centers supported by women and HIPAA-compliant cloud portal, FHACT-NET (TM), which will help in tracking the use of clinical and genomic results and provide a better understanding of community oncologists , pathologists and gynecologists.
Cancer Genetics, Inc CGIX -9,26% («CGI» or the "Company"), an emerging leader in DNA diagnostics, today announced that its own DNA test for cervical cancer, FHACT (TM), has received regulatory approval for the clinical Laboratory Improvement Amendments (CLIA) as a laboratory developed test (LDT). The tests will be available to assist in sorting and decision-making related to approximately 3500000 abnormal Pap smears in the U.S. each year to diagnose and treat cervical cancer. FHACT CGI (TM) test provides genomic information directly from samples of abnormal Pap smears and does not require additional office visits.
With the recent approval of CLIA, CGI will now provide test both domestically and in partnership with the local community OBGYN hospitals and laboratories to better manage and report the detection and staging of HPV-related cervical cancer. The test was launched in some countries outside the United States in June 2013.
FHACT (TM) test, which is designed for HPV cancer, was developed and approved by CGI in a research collaboration with the National Cancer Institute (NCI). These studies were 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 (TM) as an aid in the screening of women with HPV-positive abnormal lesions cervix. CGI and NCI continue the ongoing assurances to support the utility of the test in genomic testing and screening for cervical cancer directly from the Pap smear.
With only 3,700 cases of cervical squamous cell carcinoma is diagnosed on the basis of a biopsy 2500000 done each year in the United States, there is a need to identify women who are at risk of developing cervical cancer more effectively, reduce the burden of health care at the expense of a less invasive procedure, and to improve the diagnostic accuracy of genomic . FHACT potential for more accurate and early diagnosis of HPV anomalies can save valuable time during the testing process, a substantial cost savings to the health system.
Almost all cases of cervical cancer 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 related to other HPV-related cancers. CGI began research to develop and improve its FHACT (TM) test for these additional indications as well.
In order to support education, adoption and use of FHACT (TM) and improve outcomes for patients, CGI Launches FHACT-NET (TM). FHACT-NET (TM) is a cloud-based, HIPAA-compliant database that will compile data from clinical sites performing FHACT (TM) test and a source of genomic knowledge on the basis of information from the curator of the de-identified samples. Network participants will include both national and international laboratories, cancer centers and hospitals.
Panna Sharma, President and Chief Executive Officer, commented: "The approval of our test based on the NCI study will be enhanced by the development of active storage of important data, from which we can continue to increase our understanding of HPV cancer ultimate goal. This deeper understanding is the commercialization of the tests, improve patient care by making data-driven refinements to our algorithm, so that a more accurate and more cost-effective HPV diagnosis of cancer can be made. "
On the genetics of cancer:
Cancer Genetics, Inc is an emerging leader in the DNA of cancer diagnosis, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict outcomes. These cancers include hematological, urogenital and HPV cancer. We also offer a wide range of non-proprietary oncology oriented tests and laboratory services that provide critical genomic information for medical professionals, as well as biopharmaceutical and biotechnology companies. Our state-of-the-art Loboratoriya completely focused on maintaining clinical excellence and as a CLIA certified and CAP accredited and has licenses from several states, including New York. We have created a strong research collaboration with leading cancer centers such as Memorial Sloan-Kettering, Cleveland Clinic, Mayo Clinic and the National Cancer Institute. For more information, please see www.cancergenetics.com.
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 facts (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks associated with the development and / or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and opportunity to obtain future capital, maintenance of intellectual property rights and other risks described 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 statements.