•The Mantle-Cell and Follicular Lymphoma Tests Were Validated In Research Collaborations With Memorial Sloan Kettering and Have Been Successfully Licensed Under Both CLIA and New York State Regulations•Tests Address Over One-Third of non-Hodgkin Lymphomas And Will Be Made Available As Part of Comprehensive Testing Programs To Provide Targeted Diagnostic And Prognostic Information
RUTHERFORD, N.J., May 5, 2014 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) ("CGI" or the "Company"), an emerging leader in DNA-based diagnostics, today announced it has received CLIA and New York state approvals for clinical use of its proprietary mature B-cell neoplasm array, or MatBA® for Follicular Lymphoma (MatBA®-FL) and Mantle-Cell Lymphoma (MatBA®-MCL). Both tests further extend the portfolio in hematologic cancers being developed by CGI and both were developed and validated via a research collaboration with Memorial Sloan-Kettering Cancer Center. MatBA®-FL and MatBA®-MCL assist clinicians in the prognosis of Follicular Lymphoma (FL) and Mantle-Cell Lymphoma (MCL). MatBA®-FL identifies genomic aberrations that are associated with the high frequency of transformation of FL into Diffuse Large B-Cell Lymphoma (DLBCL) and shorter overall survival (OS). MatBA®-MCL identifies genomic aberrations that are associated with high frequency of either a leukemic involvement and/or shorter OS. Understanding the potential outcome for the patient is critical in making informed choices about treatment selection, clinical trial involvement and patient management.
Lymphoma is the most common form of blood cancer and is divided into two main categories: Hodgkin Lymphoma (HL) and non-Hodgkin lymphoma (NHL). In 2014, it is estimated that there will be 70,800 new cases of non-Hodgkin lymphoma and an estimated 18,990 people will die of this disease. FL and MCL are two of several subtypes of NHL. FL, a B-cell lymphoma, is the most common indolent (slow growing) form of NHL, accounting for approximately 25% to 30% of all non-Hodgkin lymphomas. Often, people with FL have no obvious symptoms of the disease at diagnosis. MCL is a rare B-cell cancer that most often affects men over the age of 60. The disease may be very aggressive, but it can also behave in a more indolent fashion in some patients. MCL comprises about 5% of all NHL. MCL is usually diagnosed as a late-stage disease that has typically spread to the gastrointestinal tract and bone marrow.
"The accurate and early diagnosis and prognosis of lymphomas is central to providing more targeted and personalized treatment," said Panna Sharma, Chief Executive Officer of Cancer Genetics. "Our MatBA® microarrays are highly validated and accurate genomic-based tests designed to precisely give a prognosis, allowing doctors to more accurately select treatments options. These tests also allow drug development companies the opportunity to recruit the proper patients into their clinical trials, and monitor genomic changes and response during a trial thereby increasing the likelihood of clinical trial success."
CGI's MatBA® platform has been designed to detect chromosomal gains and losses at over 80 specific genomic sites associated with mature B-cell neoplasms. MatBA® is designed for use in a clinical laboratory and is optimized for use on a range of specimen types such as peripheral blood, bone marrow, cell suspension, and formalin-fixed paraffin-embedded tissue specimens. MatBA® improves each patient's prognosis by determining the patient's unique genetic profile, allowing doctors to more accurately select treatments to which the patient is most likely to respond. No time is wasted with treatment that will not work which is vital for many cancers requiring immediate therapy.
The MatBA®-FL and MatBA-MCL joins the Diffuse Large B-Cell Lymphoma (DLBCL) CompleteSM program offered by CGI, which includes a suite of esoteric tests used in the diagnosis, prognosis and clinical management of DLBCL patients. CGI is a Center of Excellence for Chronic Lymphocytic Leukemia (CLL) and DLBCL management by servicing world-class and proprietary capabilities for the diagnosis, prognosis and monitoring of these diseases.
For more information on the MatBA product line, please visit http://www.cancergenetics.com/products/matba/
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, 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, 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.
CONTACT: Investor Relations
Michael RiceLife Science Advisors LLC
RedChip Companies, Inc.Paul Kuntz, 800-733-2447, ext. 105
Source: Cancer Genetics