Clarient, Inc. Launches Insight(R) Dx Mammostrat(R) Breast Cancer Recurrence Test
The Mammostrat test employs an optimal set of five biomarkers that are able to be identified visually on a patient's tumor specimen by using a well-established technology called immunohistochemistry. Those biomarkers are then analyzed using a mathematical algorithm to generate an assessment of risk for cancer recurrence.
Mammostrat is well-validated, having been clinically studied on more than 3,000 women, as reported in multiple peer-reviewed journals, including Breast Cancer Research (Volume 12, 2010), Clinical Cancer Research (Volume 14, October 2006), and the Journal of Clinical Oncology (Volume 24, July 2008). Data fromMammostrat trials have also been presented at national conferences, including the American Society of Clinical Oncology (ASCO) and the San Antonio Breast Cancer Symposium.
By using the Mammostrat test pathologists, oncologists and patients can gain greater understanding of the aggressiveness of a patient's disease and guide clinical management. Mammostrat provides additional clinical information that cannot be obtained from routinely used prognostic factors. The Mammostrat test can be performed on small biopsy samples, and results are typically delivered in as little as 48-72 hours, thereby allowing more rapid treatment decisions.
"Mammostrat can be an important tool for clinicians assessing the aggressiveness of their patient's breast cancer," said Clarient Vice Chairman and Chief Executive Officer Ron Andrews. "Mammostrat results can provide clinicians important information to help select the appropriate therapeutic management for each individual patient. For patients, Mammostrat offers the confidence that the decisions being made to manage their breast cancer are based on the clinical characteristics of their specific disease using the most current validated technology available."
More than 210,000 women in the U.S. develop breast cancer each year. Mammostrat test development was targeted to breast tumors which express estrogen receptor, the most commonly identified subtype of breast cancer representing about 75 percent of the women diagnosed each year. The standard of care for most of these patients includes surgery to remove the tumor, followed by anti-hormonal therapy (e.g. tamoxifen or aromatase inhibitors).
Andrews continued, "Mammostrat fits well within the combined Clarient goals of bringing value to both the patient and to the healthcare system. The test provides validated information more rapidly than other tests currently available, which may allow for treatment to begin earlier in the course of the disease."
Clarient is currently in coverage determination discussions with both government and private insurance carriers. Patents covering the use of the Mammostrat test were granted in the U.S. and Europe in the summer of 2010.
For more information on the Mammostrat test, please visit www.clarientinc.com/mammostrat.aspx.
About Clarient
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 dedicating itself to collaborative relationships with the healthcare community to translate cancer discovery and research into better patient care. Clarient's principal customers include pathologists, oncologists, hospitals, and biopharmaceutical companies. The rise of individualized medicine as the new direction in oncology has created the need for a centralized resource providing leading diagnostic technologies, such as flow cytometry and molecular testing. Clarient is that resource, having created a state-of-the-art commercial cancer laboratory providing the most advanced oncology testing and diagnostic services. Clarient's customers are connected to its Internet-based portal, PATHSiTE® that delivers high resolution images and critical interpretive reports based on our diagnostic testing. Clarient also develops and markets new, proprietary "companion" diagnostic markers for therapeutics in breast, prostate, lung, ovarian, and colon cancers, and leukemia/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 attract and retain highly qualified managerial, technical, and sales and marketing personnel, Clarient's ability to maintain compliance with financial and other covenants under its credit facility, Clarient's ability to successfully manage its in-house billing and collections processes, the continuation of favorable third-party payor reimbursement for laboratory tests, changes in federal payor regulations or policies, including adjustments to Medicare reimbursement rates, that may affect coverage and reimbursement for Clarient's laboratory diagnostics services, Clarient's ability to obtain additional financing on acceptable terms or at all, unanticipated expenses or liabilities or other adverse events affecting cash flow, uncertainty of success in identifying, developing and commercializing new diagnostic tests or novel markers including the Mammostrat® test, Clarient's ability to fund development of new diagnostic tests and novel markers, and to obtain adequate patent protection covering Clarient's use of these tests and markers including for the Mammostrat® test, and the amount of resources Clarient determines to apply to novel marker development and commercialization, 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, failure to obtain regulatory approvals and clearances required to conduct clinical trials if/when required and/or to commercialize Clarient's services and underlying diagnostic 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, and risks detailed from time to time in Clarient's SEC reports, including quarterly reports on Form 10-Q, current reports on Form 8-K, and annual reports on Form 10-K. Recent experience with respect to laboratory services, net revenues and results of operations may not be indicative of future results for the reasons set forth above.
Clarient does not assume any obligation to update any forward-looking statements or other information contained in this document.
SOURCE Clarient, Inc.