- CGI's proprietary genomic test has been CLIA and NYS licensed to stratify CLL and SLL patient into three distinct outcome groups: favorable, intermediate, and unfavorable
- It is the only comprehensive test to report on 20 clinically-validated and disease-relevant genomic regions focused on CLL and SLL
- The proprietary genomic test addresses a growing market of over 120,000 patients for the most common form of leukemia (CLL/SLL)
RUTHERFORD, N.J., Aug. 4, 2014 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) ("CGI" or the "Company"), an emerging leader in DNA-based cancer diagnostics, announced today the launch of an updated MatBA®-CLL/SLL test which provides greater clarity of risk and outcome for patients. CGI's proprietary test for mature B-cell neoplasms now reports information on twenty genomic sites, affording clinical interpretation and improved stratification and prognostication of Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) patients. It is the only genomic test commercially available for the stratification of CLL and SLL patients into three distinct risk categories: favorable, intermediate, and unfavorable. By more accurately stratifying patients with these B-cell malignancies, CGI's updated MatBA®-CLL/SLL will enable doctors to better personalize patient management and improve patient outcome.
In the U.S. alone, an estimated 120,000 individuals are currently living with CLL, most of whom need routine monitoring and testing. CGI's improved diagnostic tool meets a critical need for better prognostication in this patient group. Improved knowledge of the genomics of leukemias and lymphomas, along with the development of more targeted therapeutics such as Idealisib and Ibrutinib, are among the recent advancements made in the personalization of treatment that help manage patients with CLL and SLL.
Panna Sharma, CEO of CGI, stated: "We are in the midst of a renaissance in our understanding of leukemias and lymphomas. The continued development and improvement of our MatBA®-CLL/SLL test further demonstrates our commitment to being a leader in the development of genomic diagnostics for hematological cancers. With our improved MatBA®-CLL/SLL test, doctors will be able to determine the best clinical management strategy and treatment options for each individual patient. Additionally, CGI's biotech and biopharma customers will be able to use the test to more efficiently stratify and monitor patients for their clinical trials. This is an exciting development for CGI. We are committed to ensuring that these tests are widely available, and expect continued, broad adoption of MatBA® in the clinical setting."
The new regions assessed by CGI's MatBA®-CLL/SLL test were validated in a study published in the April edition of Leukemia & Lymphoma. Noting the importance of the study's results and CGI's updated test for patient management and treatment, Jane Houldsworth, Ph.D., Vice President of Research and Development at CGI, explained, "Without assessing these additional biomarkers, 7.9% of patients who had a poor prognosis were improperly categorized as having a favorable outcome. By adding these additional poor prognostic markers, the updated MatBA®-CLL/SLL can better identify those patients with high-risk disease who would otherwise have been categorized as having a good/intermediate prognosis. Importantly, the test now offers a clearer distinction between those patients with an overall good prognosis and those with an intermediate survival. Because current FISH probe technology can only stratify patients into two groups (favorable and unfavorable) the additional regions offer a major improvement in prognostication. With the information provided by the updated MatBA®-CLL/SLL test, doctors can make more informed decisions about how to clinically manage their patients."
Significant strides have recently been made in the treatment of hematological cancers. On July 23, 2014, the FDA approved Gilead's Zydelig® for relapsed CLL, SLL, and FL and in February of 2013, Pharmacyclics' Ibrutinib® was approved for use in patients with CLL. As the number of hematological cancers diagnosed each year continues to rise, biopharmas are increasingly interested in finding new treatment options for these diseases, and the need for better and more comprehensive molecular diagnostic tests continues to expand in order to meet the needs of personalization and cost-reduction in patient management. CGI will continue to market the updated MatBA®-CLL/SLL, which is CLIA and NYS licensed, to biotech and biopharma companies, oncology clinics, hospitals, and cancer centers in the U.S., Asia, and Europe.
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 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.