Novel breast cancer test classifies risk of recurrence of breast cancer
Aliso Viejo, Calif. – Clarient, Inc. (NASDAQ: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that a manuscript based on a study of Clarient Insight®Dx Mammostrat®, a test used to classify the risk of recurrence of breast cancer following surgery and chemotherapy, will be published in an upcoming edition of Breast Cancer Research, a prominent peer-reviewed medical journal. The manuscript, currently available in provisional format at the journal website (http://breast-cancer-research.com), is titled “Mammostrat® as a Tool to Stratify Breast Cancer Patients at Risk of Recurrence during Endocrine Therapy.”
The manuscript reports the results of a 1,540-patient study, led by John Bartlett, Professor of Molecular Pathology at the University of Edinburgh in Scotland, further validating the Mammostrat test as an aid for risk-stratifying early stage hormone receptor-treated breast cancer patients. In addition, the manuscript reports for the first time that the Mammostrat test may be useful as a tool for risk-stratifying, node-positive patients and those who do not express hormone receptors.
More than 210,000 women in the U.S. develop breast cancer each year. Mammostrat development was targeted to breast tumors which express estrogen receptor, the most commonly seen subtype of breast cancer. The standard of care for most of these patients is surgery to remove the tumor, followed by anti-hormonal therapy (e.g. tamoxifen or aromatase inhibitors). Mammostrat testing will help pathologists, oncologists and patients decide whether additional aggressive chemotherapy should be added to the treatment regimen.
The Mammostrat test had its origins in transcriptomic measurement of tens of thousands of genes, but Clarient scientists developed a simplified clinical grade assay by using a proteomic approach to screen hundreds of candidate markers on thousands of tissues. An optimal set of five biomarkers, able to be visualized directly on the tumor specimen, were identified which are combined using a mathematical algorithm into an assessment of risk for cancer recurrence after standard treatment. “We believe Mammostrat will bring a novel approach to tumor classification enabling pathologists to deliver a comprehensive pathological report at the time of diagnosis,” said Ron Andrews, Clarient Vice Chairman and Chief Executive Officer.
“Mammostrat has now been validated in five studies involving more than 3,000 women, including comparable results in the same patient cohort used to develop and test the leading breast cancer prognostic test on the market,” Andrews added. “From a commercial standpoint, Mammostrat is an example of the maturation of our breast cancer product line, strengthening our service offering to our pathology clients. It also further expands our menu of proprietary tests that personalize medicine and give patients important information for managing their disease while maintaining a good quality of life.”
Professor Bartlett said, “Mammostrat is different from most risk classifiers in that it does not rely on measurement of surrogates for hormone receptor status, proliferation or tumor grade to risk-stratify. It offers the potential for a broader assessment of tumor aggressiveness by adding Mammostrat risk stratification to traditional risk classifiers.”
Clarient Chief Medical Officer Ken Bloom, M.D. added, “Competing tests measure RNA from ground-up tumor tissue. Mammostrat measures protein expression specifically in the invasive tumor cells, ensuring biomarkers are expressed in the cells of interest, a feature that is very important in actual clinical practice. Given our strong market presence in breast cancer, these new findings will further strengthen our menu of solutions for classifying the aggressiveness of breast cancer and will allow our pathology clients to provide a more thorough assessment of each breast cancer.”
The Company is targeting the fourth quarter of 2010 for Mammostrat commercialization.
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.
Media Contact: Matt Clawson
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.