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Response Genetics, Inc. to Offer ROS1 Testing for Lung Cancer


11/5/2012 10:45:29 AM

LOS ANGELES, Nov. 5, 2012 /PRNewswire/ -- Response Genetics, Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, announced today the launch of testing for ROS1 gene rearrangements. Recently, the Massachusetts General Hospital Cancer Center ("MGH") published studies showing that ROS1 driven tumors are sensitive to the FDA approved drug XALKORI®1 (crizotinib)2 to treat non-small-cell lung cancer ("NSCLC") patients with ALK gene rearrangements. Tumors driven by rearrangements in the ROS1 gene represent an additional 1 to 2 percent of patients who may be candidates for crizotinib therapy.3 The company will offer both fluorescence in situ hybridization ("FISH") and polymerase chain reaction ("PCR") based ROS1 translocation testing.

"We are pleased to add ROS1 to our growing test menu," said Thomas Bologna, chairman and CEO of Response Genetics. "We believe the dual option of FISH and PCR represent a unique offering and is consistent with our Leave No Stone Unturned program whereby we go to great lengths to help patients receive optimal therapy. While FISH is the technology that has been used for ROS1 to date, PCR has the advantage of providing additional information about the variant found, information that may be useful for evaluating response and resistance mechanisms. This promising new marker is now readily available to pathologists and oncologists seeking fast turnaround time and utilizes the company's proprietary methods that enable results on very small biopsies including fine needle aspirates."

ROS1 supplements the company's recently introduced Leave No Stone Unturned program, in which patients whose tumors test negative for the ALK Break Apart FISH assay receive follow-up ALK testing using the company's proprietary EML4-ALK RT-PCR-based assay at minimal additional cost. With the addition of ROS1, ordering clinicians can now make a more complete evaluation of each of their NSCLC patients as candidates for crizotinib therapy.

1 XALKORI® is a registered trademark of Pfizer, Inc.
2 Bergethon et. al. "ROS1 rearrangements define a unique molecular class of lung cancers." Journal of Clinical Oncology 2012 Mar 10;30(8):863-70. Epub 2012 Jan 3.
3 Ibid

About Response Genetics, Inc.

Response Genetics, Inc. (the "Company") is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. The Company's technologies enable extraction and analysis of genetic information derived from tumor cells stored as formalin-fixed and paraffin-embedded specimens. The Company's principal customers include oncologists and pathologists. In addition to diagnostic testing services, the Company generates revenue from the sale of its proprietary analytical pharmacogenomics testing services of clinical-trial specimens to the pharmaceutical industry. The Company's headquarters is 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 the Company 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 provide clinical testing services to the medical community, to continue to expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, to strengthen marketing capabilities, to expand the suite of ResponseDX® products, to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into areas of companion diagnostics, and to continue to execute on its business strategy and operations, to continue 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, and other statements identified by words such as "project," "may," "could," "would," "should," "believe," "expect," "anticipate," "estimate," "intend," "plan" 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 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.

Investor Relations Contact:

Company Contact:

Peter Rahmer

Thomas Bologna

Trout Group

Chairman & Chief Executive Officer

646-378-2973

323-224-3900

SOURCE Response Genetics, Inc.



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