Clarient Announces U.S. and European Patents Allowed for Mammostrat® Breast Cancer Prognostic Test

ALISO VIEJO, Calif., Aug. 10 /PRNewswire-FirstCall/ -- Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that the United States Patent and Trademark Office and the European Patent Office have allowed patents covering the technology behind Clarient Insight® Dx Mammostrat®, a test designed to aid in the classification of the risk of recurrence of breast cancer following surgery and initial treatment.

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 a patient's treatment regimen.

Ron Andrews, Clarient Vice Chairman and Chief Executive Officer, said, "Gaining allowance of these important patents represents another milestone for Clarient. Our strategy of using our proprietary cancer biomarkers and correlating them to clinical outcomes is paying off as we continue to develop novel diagnostic and prognostic tests. These patents, as well as our UK and U.S. patents for TLE3 announced earlier this summer, differ from standard gene patents as they are linked to specific clinical utility."

The test has been validated in studies involving more than 3,000 women, including a recent study of 1,540 patients from the University of Edinburgh in Scotland that was published in this month's edition of Breast Cancer Research, a prominent peer-reviewed medical journal. Those studies have all validated the Mammostrat test as an aid for risk-stratifying early stage hormone receptor-treated breast cancer patients.

"We continue to place a high level of importance on establishing a broad field of intellectual property surrounding our core proprietary technologies since they are what set us apart as a molecular diagnostics company from other lab service providers," Andrews added.  "We view these assets as critical to the growth and success of our business and to increasing shareholder value. The strength of our discovery engine continues to be unveiled, and we look forward to sharing the progress on our rich pipeline through the coming quarters."

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.

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