Response Genetics Launches EML4-ALK Genetic Test in Lung Cancer

Response Genetics Inc. (Nasdaq: RGDX), 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 detect the presence of EML4-ALK gene variants in lung cancer patients. EML4-ALK fusion genes are present in about four percent of tumors from patients with non-small cell lung cancer (NSCLC). These rearranged genes promote tumor cell growth and predict lack of benefit from therapies that inhibit EGF receptor (EGFR) activity¹.

Recently, ALK inhibitors have entered clinical development and shown efficacy in NSCLC patients harboring EML4-ALK fusion proteins². Response Genetics’ proprietary PCR-based assay is capable of rapidly detecting and identifying nine known fusion gene variants in archival tissue³. This new test is expected to be useful for large-scale screening of tissue samples and is available nationwide through the company’s sales force.

"Response Genetics is committed to expanding its existing ResponseDX™ tests as genes that correlate with therapeutic benefit are identified,” said Kathleen Danenberg, Response Genetics president and CEO. "We are encouraged by the rapid acceptance and use of our EML4-ALK test by the oncology community. With the addition of EML4-ALK, our ResponseDX: Lung™ genetic panel gives physicians even more information to help this unique group of patients with treatment-resistant lung cancer.”

By assessing mutations and expression levels across multiple genes, the ResponseDX: Lung™ genetic test panel may help physicians tailor treatment to their patients, potentially improving outcome to therapy for the more than 200,000 newly diagnosed lung cancer patients in the U.S. yearly.

About ResponseDX™ Tests

Response Genetics Inc. 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™ 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 (EGFR) expression. These test panels also include the analysis of EGFR gene mutations in NSCLC and K-ras (KRAS) gene mutations and BRAF mutations in colorectal cancer. Using ResponseDX™ 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.

About Response Genetics, Inc.

Response Genetics Inc. ("RGI”) 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, the Company generates revenue from the sales of its proprietary analytical pharmacogenomic testing services of clinical trial specimens to the pharmaceutical industry. RGI 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 continue to expand its ResponseDX test panels, the utility of EML4-ALK fusion protein, the ability of the Company to continue to develop novel PCR bases assays, the continued utility of ResponseDX™ tests to assist in tailoring treatment, the ability to continue to maintain its growth, the ability of the Company to successfully integrate the roles of operations, strategy and business development, 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 Shaw A, Yeap BY, et al. Clinical features and outcome of patients with non-small-cell lung cancer who harbor EML4-ALK. J Clin Oncol 2009;27:4247–4253.

² Saski T, Rodig SJ, et al. The biology and treatment of EML4-ALK non-small cell lung cancer. 2010. Eur J Cancer Jul;46(10):1773-80.

³ Danenberg PV, Stephens C, et al. A novel RT-PCR approach to detecting EML4-ALK fusion genes in archival NSCLC tissue. Presented at ASCO 2010;abstr 10535.