Clarient Insight(TM) Dx Breast Cancer Profile Represents First Molecular
Test Applicable to All Stages of Operable Breast Cancer
ALISO VIEJO, Calif., Jan. 9 /PRNewswire-FirstCall/ -- Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that it will commercialize a novel breast cancer test, the first molecular test available that is applicable to all stages of operable breast cancer, including lymph node-positive patients. The new offering, called Clarient Insight(TM) Dx Breast Cancer Profile, will be sold by Clarient through an exclusive license agreement with Prediction Sciences, a La Jolla, CA-based company that develops high-value molecular diagnostics for disease detection, prognosis and selection of appropriate therapy.
Clarient's Insight Dx Breast Cancer Profile is a series of molecular assays that, when combined using Prediction Sciences' proprietary algorithm, offer information designed to help individual patients and their physicians understand the risk of recurrence and assist them in selecting the most appropriate therapy. The profile could allow patients to avoid the toxic effects of unnecessary chemotherapy, thereby reducing the overall cost of care. The availability of the test through Clarient reflects the healthcare industry's move toward personalized medicine that helps physicians understand the unique aspects of a patient's disease in order to develop more effective treatment plans. Leading oncology organizations have recommended adopting this type of test since a large percentage of women who undergo chemotherapy have little chance of benefiting from the toxic treatment. According to industry analysts, the potential market for breast cancer tests that identify recurrence risk is estimated to be between $300 million and $400 million annually in the U.S.
The new breast cancer profile, the most significant test to date in Clarient's novel marker program, is the first product in Clarient's Insight Dx line of molecular tests. These tests are being commercialized to provide valuable cancer characterization information for prognosis and therapy selection for the major cancer types.
"This new agreement provides Clarient with an important addition to our breast cancer menu -- a new molecular diagnostic test that we believe predicts the likelihood of disease recurrence, and ultimately the benefit of chemotherapy for patients," said Clarient's President and CEO Ron Andrews. "Along with its significant value for the over 35,000 breast cancer patients we expect to test this year, Clarient's Insight Dx Breast Cancer Profile has the potential to deliver a significant economic opportunity for the company."
"We are excited to have entered into this agreement with Clarient," said Cornelius Diamond, Chief Executive Officer of Prediction Sciences. "The Clarient Insight Dx Breast Cancer Profile is the first in a pipeline of tests developed by Prediction Sciences that we believe will significantly improve and personalize patient care. We believe that Clarient is well positioned to commercialize this test and provide invaluable benefit to breast cancer patients and their physicians, allowing them to make informed treatment decisions."
Andrews added that the Clarient Insight Dx Breast Cancer Profile is the first of its kind to combine proteomic and genomic markers with tumor morphology data received directly from the patient's pathologist, thereby allowing a more accurate characterization of the disease.
"This clearly fits our business model of engaging and empowering the community pathologist in the analysis process," Andrews said. "We believe that our strong cancer-focused brand, support and loyalty among community pathologists and our unique, Internet-based PATHSiTE(TM) delivery system will drive market acceptance for this exciting test."
The new breast cancer profile has undergone rigorous validation. The results to date show excellent accuracy and substantial out-performance of standard treatment guidelines. As preparations are made for full market launch in 2008, the companies will continue to generate clinical data designed to further expand the established indications and to comply with future regulatory requirements. The companies believe that Clarient's Insight Dx Breast Cancer Profile fits the description of a lab-developed test according to the current regulatory guidelines. Should the FDA adopt proposed guidance to regulate certain lab-developed tests, the companies intend to submit the required documentation for clearance within the timeframe provided.
"Clarient currently performs approximately 20 percent of all breast cancer prognostic work-ups in the U.S.," Andrews continued. "We are extremely proud of the brand we have developed in such a short period in the area of breast cancer, and the availability of this high-value test could improve patient care and decrease the economic burden on the healthcare system."
About Prediction Sciences
Based in La Jolla, California, Prediction Sciences develops high-value molecular diagnostics and assays for disease detection, prognosis, and treatment outcome prediction under their trademarked brand names, RapidResponse(TM) and GeneRx(TM). Prediction Sciences has a deep diagnostics pipeline, with lead candidates that address critical unmet clinical needs in oncology and stroke. Prediction Sciences is committed to improving the safety and efficacy of disease treatments, and their diagnostic tests are making personalized medicine a reality. http://www.predict.net
Clarient combines innovative technologies with world class expertise to assess and characterize cancer. Clarient's mission is to provide the services, resources and critical information to improve the quality and reduce the cost of patient care as well as accelerating the drug development process. The Company'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 drug development services available both onsite and over the web. Clarient is a Safeguard Scientifics, Inc. partner company. http://www.clarientinc.com
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company, builds value in growth-stage technology and life sciences businesses. Safeguard provides growth capital as well as a range of strategic, operating and management resources to our partner companies. Safeguard participates in growth buyout financings, including corporate spin-outs and management buyouts, expansion financings, industry consolidations and early-stage financings. http://www.safeguard.com
The statements herein regarding Clarient, Inc. contain forward-looking statements that involve risks and uncertainty. Future events and the Company'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 effectively market the Clarient Insight Dx Breast Cancer Profile and market acceptance of the new test, the ability of Prediction Sciences and Clarient to obtain and maintain necessary regulatory approvals to commercialize the Clarient Insight Dx Breast Cancer Profile (including FDA clearance if determined by the FDA to be necessary or if, as expected, the FDA adopts current proposed guidance to regulate certain in vitro diagnostic devices such as the Clarient Insight Dx Breast Cancer Profile), Clarient's ability to continue to develop and expand its diagnostic services business, Clarient's ability to expand and maintain a successful sales and marketing organization, Clarient's ability to maintain compliance with financial and other covenants under its credit facilities, the continuation of favorable third party payer reimbursement for laboratory tests, unanticipated expenses or liabilities or other adverse events affecting cash flow, uncertainty of success in identifying and developing new diagnostic tests or novel markers, 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 the Company's SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. Recent experience with respect to laboratory services, revenues and results of operations may not be indicative of future results for the reasons set forth above.
The company does not assume any obligation to update any
forward-looking statements or other information contained in this document.
Allen & Caron, Inc.
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