ALISO VIEJO, Calif., April 21 Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that data from a new study suggest that the Clarient Insight® Dx Pulmotax(TM) assay may effectively predict which lung cancer patients will respond favorably to chemotherapy. The study, titled "TLE3 expression is predictive of response to chemotherapy in NSCLC," included 368 samples from carcinoma patients. The majority of advanced-stage patients who were treated with chemotherapy received a treatment regimen containing a taxane class agent.
Pulmotax is a single antibody immunohistochemistry test created to detect the expression of TLE3 in non-small cell lung cancer (NSCLC). Prior data have linked TLE3 expression specifically to response to taxane therapy in breast and ovarian carcinoma patients. The study was presented yesterday at the annual meeting of the American Association of Cancer Research (AACR) in Washington, D.C. by Douglas T. Ross, M.D., Ph.D., Chief Scientific Officer of Clarient.
The study summary and results may be found at http://www.clarientinc.com/Pulmotax.
Alex Soltermann, M.D., the study's principal investigator and a pathologist at the Institute of Surgical Pathology at the University Hospital Zurich, noted that for advanced NSCLC, taxane therapy is often selected as part of standard therapy; however, the inclusion of taxane carries with it an increased incidence of severe side effects which can seriously complicate patient management. Dr. Soltermann said, "In this study we saw a striking relationship between TLE3 expression in advanced lung cancer patients and response to chemotherapy in a patient population where most patients received a taxane agent as part of their treatment regimen. These results suggest that treatments may be targeted to those patients most likely to benefit from taxane therapy."
Ron Andrews, Clarient Vice Chairman and Chief Executive Officer said, "This marks the third tissue type where our proprietary TLE3 marker shows solid association to taxane therapy response. The consistent relationship between this diagnostic biomarker and tumor response in breast, ovarian and now lung carcinoma is encouraging as it represents the potential to bring to market a product that can positively impact patient care in many different solid tumor types. On the heels of our successful launch of the Clarient Insight® Dx Pulmotype® test and our emerging leadership position in EGFR receptor mutation testing, Pulmotax brings a new weapon in our arsenal of tests that will help pathologists, pulmonologists, and oncologists select appropriate therapy for lung cancer patients."
Clarient currently expects to commercially launch its product line for taxane sensitivity in the fourth quarter of 2010.
Clarient combines innovative diagnostic technologies with world-class pathology expertise to assess and characterize cancer. Clarient's mission is to become the leader in cancer diagnostics by collaborating with the healthcare community to translate cancer research and development into better patient care. Clarient's principal customers include pathologists, oncologists, hospitals and biopharmaceutical companies. The rise of individualized medicine has created the need for a centralized resource which provides leading oncology diagnostic technologies, such as flow cytometry and molecular testing. Clarient is that resource, having created a state-of-the-art commercial cancer laboratory, which provides advanced oncology testing and diagnostic services. Resulting diagnostic reports and analyses are made available to customers through Clarient's Internet-based portal, PATHSiTE®. Clarient also plans to develop and market new, proprietary "companion" diagnostic markers for therapeutics in breast, prostate, ovarian, lung and colon cancers, and leukemia and lymphoma. www.clarientinc.com
Forward Looking Statements
Certain statements herein regarding Clarient, Inc. contain forward-looking statements that involve risks and uncertainty. Future events and Clarient's actual results could differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to: Clarient's ability to continue to develop and expand its diagnostic services business, uncertainties inherent in Clarient's product development programs, Clarient's ability to expand and maintain a successful sales and marketing organization, Clarient's ability to obtain additional financing on acceptable terms or at all, uncertainty of success in identifying and developing new diagnostic tests or novel markers, Clarient's ability to fund development of new diagnostic tests and novel markers and the amount of resources Clarient determines to apply to novel marker development and commercialization, failure to obtain FDA clearance or approval for particular applications, Clarient's ability to compete with other technologies and with emerging competitors in novel cancer diagnostics and dependence on third parties for collaboration in developing new tests, Clarient's ability to successfully integrate AGI's operations, Clarient's ability to obtain adequate patent protection covering its use of TLE3, the risk to Clarient of infringement claims and the possibility of the need to license intellectual property from third parties to avoid or settle such claims, Clarient's ability to successfully validate and commercialize AGI's product offerings, Clarient's ability to commercially launch the Pulmotax test, and other tests for taxane sensitivity in breast cancer and other carcinomas, beginning in the fourth quarter of 2010, and risks detailed from time to time in Clarient's SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K.
Clarient does not assume any obligation to update any forward-looking statements or other information contained in this document.
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