LOS ANGELES--(BUSINESS WIRE)--Response Genetics Inc. (Nasdaq:RGDX - News), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced that it has expanded its ResponseDX: Lung™ genetic test panel to assess thymidylate synthase (TS), the expression of which is associated with sensitivity to pemetrexed, a drug used to treat non-small cell lung cancer (NSCLC). The company also announced the inclusion of EGF receptor (EGFR) gene expression to its ResponseDX: Colon™ genetic test panel, providing additional sensitivity to the widely used chemotherapy combination irinotecan, fluorouracil and folinic acid (FOLFIRI). Both proprietary ResponseDX™ panels are available nationwide through the company’s expanded national sales force.
As described in the NCCN 2009 Clinical Practice Guidelines in Oncology NSCLC, ERCC1, RRM1, EGFR and KRAS genes are highlighted as predictive and prognostic biomarkers in this hard-to-treat form of lung cancer.1 The ResponseDX: Lung™ genetic test panel is believed to be the only test that assesses all of these genes and has been validated by prospective clinical trials.2,3
By assessing mutations and expression levels across multiple genes, the ResponseDX™ panel test may help physicians tailor treatment to their patients and potentially help improve outcomes and reduce risk.
“This approach is the future and the future is now,” said David R. Gandara, M.D., professor of medicine, associate director of clinical research and director of the Thoracic Oncology Program, University of California Davis Cancer Center, and a director of Response Genetics.
“We are pleased with the market acceptance of the ResponseDX™ tests, which is now at a run rate of more than 700 tests ordered per quarter, an approximate 40 percent increase over the previous quarter,” said Kathleen Danenberg, Response Genetics president and CEO. “As a company, Response Genetics is committed to expanding its existing ResponseDX™ tests and developing new ones as we identify genes that correlate with therapeutic benefit. The addition of TS and EGFR to our ResponseDX: Lung™ and ResponseDX: Colon™ genetic tests, respectively, should increase their applicability by giving physicians even more information about which cancer treatments are most likely to benefit their patients.”
Approximately 160,000 colon cancer patients and 200,000 non-small lung cancer patients may benefit from these tests per year in the United States.
About ResponseDX™ Tests
Response Genetics has developed PCR-based genetic tests — ResponseDX: Lung™ and ResponseDX: Colon™ — to help physicians with therapeutic treatment decisions for patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). The proprietary ResponseDX™ panels include three key genes: excision repair cross-complementing factor 1 (ERCC1), thymidylate synthase (TS) and epidermal growth factor receptor (EGFR). These tests also include the analysis of K-ras (KRAS) gene mutations, which are a strong predictor of non-response to and no benefit from EGFR inhibitors. Response Genetics’ KRAS mutation analysis provides one of the fastest turnaround times in the industry and accurate results on the smallest biopsies. The benefit for patients is that, in many cases, no tissue samples other than the pre-treatment diagnostic biopsy will be required for the biomarker analysis. Using ResponseDX™ testing, clinicians may make better treatment decisions by adopting a cost-effective panel approach.
About Response Genetics, Inc.
Response Genetics, Inc. (“RGI”) (the “Company”) (Nasdaq:RGDX - News) 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 the ability of the Company, to analyze cancer samples, the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, the ability of the Company to expand its ResponseDX: Lung™ and ResponseDX: Colon™ tests , 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 The NCCN Clinical Practice Guidelines in Oncology™ Non-Small Cell Lung Cancer (Version 2.2009). Available at: www.nccn.org. Accessed [4/23/09].
2 Cobo, M. Isla, D, et al. Customizing cisplatin based on quantitative excision repair cross-complementing 1 mRNA expression; a phase III trial in non-small cell lung cancer. J Clin Oncol. 2007;25:2747-54.
3 Simon, G, Sharma, A, et al. Feasibility and efficacy of molecular analysis directed individualized therapy in advanced NSCLC. J Clin Oncol. 2007;25:2741-46.
Contact:
Investor Relations: Trout Group Peter Rahmer, 646-272-8526 or Media Relations: Fleishman-Hillard Barry Sudbeck, 415-318-4261
