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Response Genetics, Inc. To Present Multiple Studies at the 2008 American Society of Clinical Oncology Annual Meeting Confirming Positive Results for ResponseDX(TM) Tests

Posted on: Thursday, 29 May 2008, 09:00 CDT

Response Genetics, Inc. (Nasdaq:RGDX) will announce the results of studies that support the validity of using the molecular markers, excision repair cross-complementing factor 1 (ERCC1) and thymidylate synthase (TS) to help guide the selection of chemotherapy treatment for patients with colon cancer, non-small cell lung cancer (NSCLC) and ovarian cancer. Results of these studies are to be presented during the 2008 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, which will be held May 30 to June 3.

ERCC1 gene expression was quantified using Response Genetics' ResponseDX technology to identify patients likely to benefit from platinum-based therapies. TS gene expression was also quantified using the ResponseDX technology and shown to be an accurate predictor of response to fluoropyrimidine-based chemotherapy.

"Using new, independent patient data sets and different drug combinations, the results support the utility of ERCC1 and TS gene expression as predictive markers of chemotherapy outcome," said Kathleen Danenberg, president and CEO of Response Genetics. "This strong clinical evidence underscores the effectiveness of our ResponseDX tests for helping guide chemotherapy treatment choices, bringing new hope to cancer patients."

All studies presented used proprietary technology developed by Response Genetics to isolate RNA from formalin-fixed, paraffin-embedded (FFPE) archived tissue for quantitative RT-PCR analysis of ERCC1 and TS gene expression. Following is a summary of presentations:

Saturday, May 31, 8:00 a.m. to noon; S Hall A1

Abstract No 5564: ERCC1 gene expression as a predictor of outcome following platinum-based chemotherapy in epithelial ovarian cancer (EOC)

The expression of excision repair cross-complementing factor 1 (ERCC1) was examined in tumor samples from 145 ovarian cancer patients treated with a platinum-containing chemotherapy regime. High ERCC1 expression was found to predict a significantly worse progression-free survival (PFS) and overall survival. These data confirm previous studies of ERCC1 as a predictive marker for platinum sensitivity in ovarian cancer.

Sunday, June 1, 2:00 to 6:00 p.m.; S Hall A1

Abstract No 2541: Use of ERCC1 gene expression to predict the effectiveness of platin-based therapy in colorectal, ovarian and lung cancer

This study compared the previously described colon and ovarian ERCC1 studies with 366 patients with NSCLC treated with platinum or other chemotherapies in a multicenter phase III trial. The data show that ERCC1 gene expression is a useful predictor of the effectiveness of platin therapy in a number of cancers with precisely determinable ranges and effectiveness cut-point values.

Monday June 2, 8:00 a.m. to noon; S Hall A1

Abstract No 4115: An update of pharmacogenetic analysis of adjuvant rectal cancer patients treated with 5-fluorouracil and pelvic radiation in a phase III intergroup trial (INT-0144, SWOG 9304)

This study examined the relationship between the expression of 12 genes involved in cancer progression with clinical outcome in 105 rectal cancer patients treated with 5-fluorouracil and pelvic radiation. Results suggest that TS gene expression levels can be used to identify patients who might benefit from chemoradiation treatments involving 5-fluorouracil. These data are in agreement with previous studies and support the use of TS gene expression as a predictor of fluoropyrimidine-based chemotherapy in colorectal cancers.

Abstract No 4131: ERCC1 gene expression levels and outcome of FOLFOX chemotherapy in patients enrolled in CONFIRM1 and CONFIRM2

This study examined colon cancer tumor samples from 191 patients enrolled in CONFIRM1 and CONFIRM2 studies. ERCC1 was tested as a predictive marker of both first-line and second-line treatments. Low ERCC1 gene expression was associated with better response to the fluoropyrimidine-based chemotherapy FOLFOX in first- and second-line chemotherapy, as well as with overall survival in first- and second-line FOLFOX chemotherapy. These results are in agreement with previous Response Genetics studies of ERCC1 in colorectal cancer (JCO 2001: 4298-4304).

About Response Genetics, Inc.

Response Genetics, Inc. ("RGI"; the "Company") (Nasdaq:RGDX) is engaged in the research and development of pharmacogenomic cancer diagnostic tests based on its proprietary and patented technologies. RGI's technologies enable extraction and analysis of genetic information from genes derived from tumor samples stored as formalin-fixed, paraffin-embedded specimens. RGI currently generates revenue primarily 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. 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 make its ResponseDx:Lung(TM) and ResponseDX:Colon(TM) tests available in a number of institutions, 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.

Source: Business Wire

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