Response Genetics, Inc. (NASDAQ:RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced a new anaplastic lymphoma kinase (ALK) testing program aimed to provide clinicians a more complete picture of the ALK rearrangement status of their non-small-cell lung cancer (NSCLC) patients. The company will include its PCR-based EML4-ALK test results for patients testing negative for the ALK Break Apart fluorescence in situ hybridization (FISH) test at minimal cost.
Approximately 3 to 5 percent of NSCLC tumors have a rearrangement of the ALK gene. In addition to providing the ALK Break Apart FISH assay, which has been clinically validated to predict response to the targeted therapy XALKORI® (crizotinib), Response Genetics has a proprietary EML4-ALK RT-PCR-based assay that detects rearrangements of the ALK gene. The Response Genetics PCR test has identified ALK variants in a subpopulation of cases that are negative by FISH, and that may respond to XALKORI® treatment. Samples that test negative for ALK FISH at Response Genetics will be further tested with the Company’s proprietary ALK PCR test.
“The number of additional patients that may be identified by further testing could be small, yet the value a positive test result can bring to even one more patient is immeasurable. We are pleased to make our proprietary ALK PCR test available, at minimal cost, to pathologists and oncologists. Our goal is to provide them with actionable information they need to give every potential patient the chance to respond to effective treatment for non-small-cell lung cancer,” said Thomas Bologna, chairman and CEO of Response Genetics. “By providing both ALK FISH and ALK RT PCR testing services cost-effectively, we believe we are enabling clinicians to make more informed treatment decisions for their patients.”
About Response Genetics, Inc.Response Genetics, Inc. (“RGI”) is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer, located in Los Angeles, California. RGI’s principal customers include oncologists, pathologists and hospitals. In addition to diagnostic testing services, RGI generates revenue from the sales of its analytical testing services of clinical-trial specimens to the pharmaceutical industry. For additional 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 RGI’s plans, objectives, projections, expectations and intentions, such as the ability of RGI 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 implement operational enhancements, 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 new areas such as 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 “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 RGI’s management and are subject to significant risks and uncertainties, including those detailed in RGI’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 RGI’s control). RGI undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.