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The HerScan Test is the First Array-based Diagnostic to Comprehensively Analyze HER2 Gene Status and Patients' Tumor Genome
CombiMatrix Corporation (Nasdaq:CBMX) announced today that its subsidiary, CombiMatrix Molecular Diagnostics (CMDX), has completed clinical validation and has commercially launched the HerScan(tm) test, the first Bacterial Artificial Chromosome (BAC) Comparative Genomic Hybridization (CGH) array-based test for breast cancer. The HerScan test is designed to detect amplification of the HER2 gene in early breast cancer while simultaneously giving clinicians a complete profile of a patient's tumor genome.
"The HerScan test is the first diagnostic, in our portfolio of array-based diagnostic offerings, for a solid tumor," stated Dr. Amit Kumar, President and CEO of CombiMatrix Corporation. "The flexibility of our BAC Array Platform is underscored by the rapid release of this product, our previous releases, and additional diagnostic products in our pipeline. We look forward to the wide acceptance of the HerScan test for breast cancer testing and the benefit we expect it will have for patients."
"CMDX's validation and launch of the HerScan test, underscores my decision to join this incredibly innovative company," stated Dr. Kavita Reddy, Clinical Laboratory Director of CMDX and former Senior Director of Genzyme Genetics. "Through CMDX, I am convinced that my desire to play a role in positively impacting the future of medical diagnostics can be best realized."
The College of American Pathologists (CAP) and American Society of Clinical Oncology (ASCO) have recently recommended that HER2 status be determined in all invasive breast cancers as a prognostic marker for which patients are most likely to benefit from the breast cancer drug trastuzumab (Herceptin(r)). However, it is estimated that approximately 20 per cent of HER2 testing currently being performed by the two available methods, immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH), may be inaccurate. Although new CAP and ASCO guidelines have been issued to address inconsistencies arising from the inherent subjectivity of FISH and IHC techniques, problems with these existing methods remain unresolved (Journal of National Cancer Institute 99:1064-1065; 2007). With the HerScan test, HER2 gene copy number is objectively analyzed for the determination of amplification status (amplification, gain, no change, or loss) at the genomic level. Moreover, since the HerScan test simultaneously determines the copy number status of chromosome 17 in its entirety, differentiation of locus specific amplification versus ploidy gains is possible. In addition, the HerScan test comprehensively monitors the copy number status of loci across the entire genome. For example, also provided in this one test, is information about genomic stability and the copy number status of additional genes of prognostic significance, including TP53, c-MYC and TOP2A.
Breast cancer is the most common malignancy in women in the United States, which has over 200,000 new cases diagnosed every year. Approximately 20 per cent of newly diagnosed breast cancer cases have extra copies of the HER2 gene on chromosome 17 (called HER2-positive), and thus these patients have a concomitant poor prognosis due to the aggressive disease characteristics conferred by the extra dosage of the HER2 gene product. HER2-positive tumors are likely to respond to the Herceptin drug because it is designed to target the product of the HER2 oncogene. Conversely, it is important to accurately identify patients with normal copy number or loss of the HER2 gene (HER2-negative) because, for these patients, the risks of side effects, including cardiotoxicity, are greater than any potential benefit of the drug.
The HerScan test is designed to give pathologists and oncologists an objective measure of HER2 gene copy number with simultaneous analysis of the entire tumor genome. As a function of the enumeration of the HER2 gene through the HerScan test, patients are assigned to one of four categories of HER2 gene status: Amplification, Gain, Normal, or Loss. As part of the validation of the HerScan test, clinical testing was completed on over 100 cases of invasive ductal and invasive lobular carcinoma with known IHC and/or FISH results. The HerScan test accurately and reproducibly determined HER2 status, and in addition it clearly revealed the genomic subtypes previously reported in Cancer Research 64: 8541-8549; 2004. These subtypes include tumors showing gain of chromosome 1q; loss of chromosome 16q; amplification of the c-MYC oncogene on chromosome 8; and loss of the tumor suppressor gene P53 on chromosome 17. These additional markers, which are not simultaneously available by IHC or FISH, provide additional relevant information, enabling the clinician to make better patient management decisions and recommendations.
"The HerScan test is designed to give clinicians and their patients a precise determination of the status of the HER2 gene so that appropriate treatment decisions can be made based on the presence or absence of this important prognostic marker," said Dr. Shelly Gunn, Medical Director of CMDX. "Since this is an array-based test, it also provides clinicians additional information on the genomic instability of the tumor enabling greater prognostic information," concluded Dr. Gunn.
"We are pleased with the performance of the HerScan test in our series of validation cases," said Dr. Mansoor Mohammed, President and CEO of CMDX. "While array CGH tests were first introduced to the clinical community for the diagnosis of developmental disorders and are now an indispensable tool in that arena, it is noteworthy that array CGH was historically first developed with cancers such as breast cancer in mind. We are very proud to be the first to deliver this transformatory test to the clinical community, and we look forward to adding additional solid tumor oncology tests in the near future as we continue to leverage the information gleaned from the complete sequencing of the human genome through our partnership with the world renowned Centre for Applied Genomics in Toronto," concluded Dr. Mohammed.
About CombiMatrix Corporation
CombiMatrix Corporation is a diversified biotechnology business having its focus on the development of proprietary technologies, products and services in the areas of drug development, genetic analysis, molecular diagnostics, nanotechnology research, defense and homeland security markets, as well as other potential markets where our products and services could be utilized. The technologies we have developed include a platform technology to rapidly produce customizable, in-situ synthesized, oligonucleotide arrays for use in identifying and determining the roles of genes, gene mutations and proteins. This technology has a wide range of potential applications in the areas of genomics, proteomics, biosensors, drug discovery, drug development, diagnostics, combinatorial chemistry, material sciences and nanotechnology. Other technologies include proprietary molecular synthesis and screening methods for the discovery of potential new drugs. CombiMatrix Molecular Diagnostics, Inc. ("CMDX"), a wholly owned subsidiary of the Company located in Irvine, California, has developed capabilities of producing arrays that utilize bacterial artificial chromosomes, which also enable genetic analysis.
Additional information about CombiMatrix Corporation is available at www.combimatrix.com or call toll free: 1-800-710-0624.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the recent economic slowdown affecting technology companies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory, and competitive developments, and general economic conditions. Our Annual Report, recent and forthcoming Quarterly Reports on Form 10-Q, recent Current Reports on Forms 8-K and 8-K/A, and other SEC filings discuss some of the important risk factors that may affect our business, results of operations, and financial condition. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.
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Amit Kumar, Ph.D., President & CEO
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