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"ResponseDX(TM) tests offer physicians and their patients an objective way to chart a course of therapy during a very stressful time -- the period between diagnosis and the start of treatment," said Kathleen Danenberg, CEO and president of Response Genetics, Inc. "By personalizing care based on a tumor's genetic makeup--as opposed to the "one-size-fits-all" approach that has been the standard until now--patients can receive the drug most likely to benefit their unique situation."
ResponseDX: Gastric(TM) tests quantitatively analyze three genes: excision repair cross-complementing factor 1 (ERCC1), thymidylate synthase (TS) and human epidermal growth factor receptor 2 (HER2). ERCC1 gene expression is a molecular marker shown to correlate with sensitivity to platinum-based drugs such as cisplatin, carboplatin and oxaliplatin; TS gene expression is a biomarker for sensitivity to the drug 5- fluorouracil (5-FU), an inhibitor of DNA replication and a component of the combination 5-fluorouracil-folinic acid- oxaliplatin (FOLFOX); and HER2 is a marker for sensitivity to trastuzumab, which was recently shown to have activity in gastric cancer.(1)
Data from Response Genetics-sponsored studies and others show that in order for gastric cancer patients to derive the maximum benefit from FOLFOX therapy, expression of both ERCC1 and TS genes must be at specific levels. However, if either marker is below a specific threshold, other therapies are available as alternative options (e.g., FOLFIRI)(2,3,4).
About ResponseDX(TM) Tests
Response Genetics has developed PCR-based genetic tests -- ResponseDX tests-- to help physicians make more informed therapeutic treatment decisions for patients with non-small cell lung cancer (NSCLC), gastric cancer and colorectal cancer. The proprietary ResponseDX(TM) panels include four key genes: excision repair cross-complementing factor 1 (ERCC1), thymidylate synthase (TS), human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor expression (EGFR). These test panels also include the analysis of EGFR gene mutations in NSCLC and K-ras (KRAS) gene mutations in colorectal cancer. Using ResponseDX(TM) testing, clinicians may make better treatment decisions by adopting a cost-effective panel approach.
Response Genetics' KRAS mutation analysis provides some of the fastest turnaround times in the industry and accurate results on the smallest biopsies -- which benefits patients because, in many cases, no tissue samples other than the pre-treatment diagnostic biopsy will be required for the biomarker analysis. All tests use technology developed by Response Genetics to isolate RNA from formalin-fixed, paraffin-embedded (FFPE) archived tissue for quantitative RT-PCR analysis of gene expression and analyzed in RGI's CLIA-certified laboratory.
About Response Genetics, Inc.
Response Genetics, Inc. ("RGI") (the "Company") (Nasdaq: RGDX | Quote | Chart | News | PowerRating) is focused on the development and sale of molecular diagnostic tests for cancer. RGI's technologies enable extraction and analysis of genetic information from genes derived from tumor samples stored as formalin-fixed and paraffin-embedded specimens. In addition to diagnostic testing services, RGI generates revenue from the sales of its proprietary analytical pharmacogenomic testing services of clinical trial specimens to the pharmaceutical industry. The Company was founded in 1999 and its principal headquarters are located in Los Angeles, California. For more information, please visit www.responsegenetics.com.
Forward-Looking Statement Notice
Except for the historical information contained herein, this press release and the statements of representatives of RGI related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as defining, targeting and individualizing therapies for cancer patients, , the ability of the Company to offer its ResponseDX: Gastric test panel, to continue to expand its test panels, the use of ERCC1, TS and HER2 as predictive biomarkers for personalizing therapy, the cost-effectiveness of test panels and other statements identified by words such as "projects," "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions.
These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.
(1) Van Cutsem E, et al. Efficacy results from the ToGA trial: a Phase III study of trastuzumab added to standard chemotherapy (CT) in first-line human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (GC). Presented at the 2009 annual meeting of the American Society of Clinical Oncology, May 29-June 2, 2009, Orlando, FL. Abstract LBA4509.
(2) Shirota Y., et al. ERCC1 and Thymidylate Synthase mRNA Levels Predict Survival for Colorectal Cancer Patients Receiving Combination Oxaliplatin and Fluorouracil Chemotherapy. J Clin Oncol. Dec 1 2001:4298-4304.
(3) Vallbohmer D., et al. Molecular determinants of irinotecan efficacy. Int J Cancer 2006;119:2435-2442.
(4) Metzger, R., et al. ERCC1 mRNA Levels Complement Thymidylate Synthase mRNA Levels in Predicting Response and Survival for Gastric Cancer Patients Receiving Combination Cisplatin and Fluorouracil Chemotherapy. J Clin Oncol. 1998;16:309-316.
SOURCE: Response Genetics, Inc.
Investor Relations Contact: Trout Group Peter Rahmer, 646-272-8526 or Media Relations Contact: Fleishman-Hillard Barry Sudbeck, 415-318-4261
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