ALISO VIEJO, Calif., March 17 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 shows that Clarient's Ovotax(TM) assay may effectively predict which ovarian cancer patients will respond favorably to taxane therapy and could, therefore, be spared the potential side effects of this rigorous and sometimes toxic chemotherapy agent. The study was presented yesterday at the national meeting on Women's Cancer of the Society of Gynecologic Oncologists by Janelle Fauci, M.D. of the Department of Obstetrics and Gynecology at the University of Alabama, Birmingham (UAB).
The study, titled "Expression of TLE3 Predicts Response to Taxane Therapy in Ovarian Carcinoma," included 293 carcinoma samples. Ovotax is a single antibody immunohistochemistry test created to detect the expression of TLE3 in an ovarian tumor and thereby indicate whether the patient will respond favorably to taxane therapy.
The study summary and results may be found at http://www.clarientinc.com/Ovotax.
According to the American Cancer Society, ovarian cancer accounts for about 3 percent of all cancer diagnoses in women. It ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. About 21,000 new cases of ovarian cancer are diagnosed each year.
Warner K. Huh, MD, FACOG, FACS, the study's principal investigator, noted that for ovarian cancer patients taxane is an important therapy, which, along with a chemotherapy regimen, can markedly improve a patient's response rate; however, it also carries with it an increased incidence of severe side effects, making it important to identify which patients will most likely benefit from the therapy. Dr Huh is an Associate Professor in the Division of Gynecologic Oncology, Department of Obstetrics and Gynecology at UAB.
Dr. Huh said, "The findings from this study represent another important step towards personalized medicine and care in women diagnosed with ovarian cancer. Hopefully, we can use this information to individualize cancer care and break away from a 'one size fits all' mentality. This study contributes significantly to this new paradigm."
Ron Andrews, Clarient Vice Chairman and Chief Executive Officer said, "Having proprietary tests to help clinicians choose the most appropriate therapy is central to our menu expansion strategy. Ovotax is the first of a series of taxane-related assays that were developed at Applied Genomics, Inc. (AGI) and that Clarient is moving to commercialize this year. Following the successful launch of Clarient InSight® Dx Pulmotype® in February 2010, progress on these other tests is further evidence of the value of the AGI acquisition and our aggressive efforts to expand our menu of important proprietary cancer tests. The goal of personalized medicine is to see that cancer patients get the best chance for survival while maintaining a good quality of life. It is exciting for Clarient to be one of the companies on the forefront of this initiative, and our taxane product line promises to be an important tool for pathologists and oncologists to manage the use of this highly effective, but highly toxic drug class."
The TLE3 biomarker anchors the proprietary taxane predictive marker product line acquired by Clarient through its recent acquisition of AGI. Clarient scientists previously published evidence that TLE3 was predictive of response to taxane therapy in "triple negative" breast cancer (hormone receptor and Her2 negative). Clarient currently expects to commercially launch the taxane product line 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(TM). Clarient also plans to develop and market new, proprietary "companion" diagnostic markers for therapeutics in breast, prostate, 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 successfully validate and commercialize AGI's product offerings, Clarient's ability to successfully launch its lung cancer test, Pulmotype®, in the first quarter of 2010, Clarient's ability to commercially launch the Ovotax 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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