Response Genetics to Present Lung Cancer and Colorectal Cancer Study Results at the 2010 American Society of Clinical Onco

New Data Affirms the Clinical Utility of Cancer Biomarkers to Help Guide Chemotherapy Selection

LOS ANGELES--(BUSINESS WIRE)-- Response Genetics Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today that it will present data from eight studies investigating the clinical utility of its proprietary technology, RGI-1, during the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from June 4 to June 8, 2010. Data will highlight advances in diagnostic testing in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) and the scientific understanding of tumor biomarkers.

“The data being presented at ASCO 2010 is the product of Response Genetics’ powerful technology platform and understanding of tumor biology,” said Kathleen Danenberg, president and CEO of Response Genetics. “Our results underscore the effectiveness of predictive biomarkers in the clinical setting, which ultimately help physicians better understand and select the most personalized treatment option for their patients. Through our demonstrated commitment to research and product development, Response Genetics is advancing the field of personalized medicine.”

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

Poster Discussion Sections

Saturday June 5, 2:00 PM to 6:00 PM.; S 103

Abstract No: 10535: A novel RT-PCR approach to detecting EML4-ALK fusion genes in archival NSCLC tissue.

EML4-ALK fusion gene has been detected in subsets of NSCLC patients, especially never-smokers with adenocarcinoma, and appears to be mutually exclusive of EGFR mutations. As an alternative to using fluorescent in situ hybridization (FISH) analysis to detect EML4-ALK gene expression, we designed robust RT-PCR assays capable of rapidly detecting and identifying nine different fusion gene variants in commonly available FFPE tissues. This new methodology is expected to be useful for large-scale screening of tissue samples for EML4-ALK fusion gene products.

Saturday June 5, 2:00 PM to 6:00 PM.; S 103

Abstract No: 10522: Association of TS and ERCC1 mRNA expressions with overall survival in patients enrolled in CONFIRM 1 and CONFIRM 2.

While targeted treatments have been developed to improve survival in patients with metastatic colorectal cancer (CRC), there are currently no clinical markers to assist physicians in assessing therapeutic options. Our goal was to test TS and ERCC1 gene expression as predictive markers for FOLFOX-based therapy in tissue samples from two phase III clinical studies, CONFIRM 1 and CONFIRM 2. Using previously established cut off values to determine “high” or “low” expressors, data reaffirmed that high expression of TS and ERCC1 genes is a marker of poor prognosis. These results support the benefit of assessing tumor sensitivity to cytotoxic chemotherapeutic agents as a means of helping direct therapy.

Saturday June 5, 2:00 PM to 6:00 PM.; S 103

Abstract No: 10529: KRAS mutations in NSCLC versus CRC: Implications for cetuximab therapy.

In patients with CRC, benefit from cetuximab is mainly limited to those whose tumors contain the wild-type KRAS gene. Recent studies show no such predictive value in NSCLC patients. In this study, we compared KRAS mutation status in both cancers to determine if the unique tobacco carcinogen-related etiology of NSCLC contributes to a divergence in KRAS mutation genotype from that of CRC. Results demonstrate significant differences in both incidence and type of KRAS mutation between these tumor types. Such markers may be useful in understanding the observed predictive value of KRAS mutation for cetuximab-based therapy in NSCLC and CRC.

Monday June 7, 8:00 AM to 12:00 PM.; E450b

Abstract No: 7513: Histology- and gender-related associations of ERCC1, RRM1, and TS biomarkers in 1,802 patients with NSCLC: Implications for therapy.

Histology-based decision making for NSCLC has recently been advocated as a means to determine potential therapeutic treatment options. Specimens from 1,802 individual NSCLC patients were analyzed for one or more biomarkers to investigate the correlation between histology and gender to purported chemotherapy predictive biomarkers: ERCC1, RRM1 or TS. Primary results from this analysis, the largest dataset of these biomarkers yet reported, suggest that gender-related associations to enhanced chemotherapy sensitivity in females are partly histology-related. And that biomarker assessment in individual NSCLC patients may optimize histology-based decision making.

General Poster Sections

Saturday June 5, 8:00 AM to 12:00 PM.; S Hall A2

Abstract No: 10641: Correlations of mRNA expression levels of genes in the targeted pathways and KRAS mutation status in patients with colorectal cancer.

This study investigated the relationship between KRAS mutational status in colorectal cancer (CRC) tumors and the expression of genes involved in chemotherapy metabolism (TS, DPD), DNA repair (ERCC1), angiogenesis (VEGF, VEGF receptors) and growth factors (EGFR, KRAS). Results show correlations between mutations in the KRAS gene and genes involved in specific signaling pathways, as well as correlations between the wild type gene and other biological outcomes. Such findings suggest that KRAS mutational status may influence the activity of pathways involved in responsiveness to current CRC treatments. If verified, such information may be valuable in determining potentially effective treatment options.

Sunday June 6, 2:00 PM to 6:00 PM.; S Hall A2

Abstract No. 3563: Biomarkers for cetuximab-based neoadjuvant radiochemotherapy in advanced rectal cancer.

To identify potential subgroups of rectal cancer patients who might benefit from cetuximab-based neoadjuvant radiochemotherapy, we assessed gene expression of factors involved in tumor growth (EGFR), angiogenesis (VEGF, VEGFR1, VEGFR2d), DNA repair (ERCC1) and drug metabolism (TS), as well as KRAS gene mutation status. Results suggest that EGFR and VEGF expression and KRAS mutational status in tumors are predictive markers of neoadjuvant cetuximab-based chemoradiation response in patients with locally advanced rectal cancer.

Sunday June 6, 2:00 PM to 6:00 PM.; S Hall A2

Abstract No: 3640: Association of intratumoral gene expression levels of TP and VEGF with clinical outcome in stage II/III rectal cancer patients treated with 5-FU and pelvic radiation in a phase III intergroup trial (SWOG 9304).

Despite the availability of neoadjuvant or adjuvant 5-FU and radiation therapy, stage II/III rectal cancer patients have an overall five-year survival rate of approximately 50 percent. To understand the molecular basis of this observation, expression levels of 12 genes involved in critical pathways of cancer progression were determined; TS, TP, DPD, GSTP1,VEGF, IL-8, COX-2, EGFR, CyclinD1, P53, ERCC1, ERCC2. Data suggest expression levels of TP and VEGF may help to identify patients with rectal cancer who might benefit from 5-FU and radiation therapy.

Sunday June 6, 2:00 PM to 6:00 PM.; S Hall A2

Abstract No: 3590: Association of GRP78 polymorphisms with response and TTP in patients with mCRC treated with FOLFOX/BV or XELOX/BV.

Recent data suggest that GRP78, a major endoplasmatic chaperone protein, may be critical for tumor angiogenesis, and its overexpression may protect cancer cells from apoptosis, thereby promoting metastasis and chemoresistance. The authors of this study tested whether germ-line polymorphisms within the GRP78 gene were associated with clinical outcome in metastatic CRC patients treated with FOLFOX/BV or XELOX/BV. Results suggest that GRP78 gene polymorphisms may be potential predictive markers to FOLFOX/BV and XELOX/BV therapeutic benefit in metastatic CRC patients. Moreover, GRP78 polymorphisms may play a major role in VEGF-independent tumor angiogenesis.

About Response Genetics, Inc.

Response Genetics, Inc. (“RGI”) (the “Company”) (Nasdaq: RGDX) 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

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.


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