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Clarient s Insight Dx Breast Cancer Profile Validated by New Data

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^{Published in Science and Technology on Thursday, December 11th 2008 at 7:05 GMT, Last Modified on 2009-11-02 16:27:17 by Market Wire}  

ALISO VIEJO, Calif. & SAN ANTONIO--([ BUSINESS WIRE ])--[ Clarient, Inc. ] (Nasdaq:CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists and the pharmaceutical industry, announced today that new data will be presented during the [ San Antonio Breast Cancer Symposium ], validating Clarient's new prognostic breast cancer profile – Clarient Insight^TM Dx.

The data will be presented by [ Prediction Sciences ] at 5:30pm CT in Exhibit Hall B at the [ Henry B. Gonzalez Convention Center ] in San Antonio, TX. In January 2008, Clarient announced that it was planning to develop and sell Clarient InsightDx Cancer Profile through an exclusive license agreement with Prediction Sciences, a La Jolla, California-based company that develops high-value molecular diagnostics for disease detection, prognosis and selection of appropriate therapy.

This data shows that Clarient Insight Dx will accurately predict future event risk in operable hormone-receptor-positive breast cancer patients. In addition, the data shows that a prototype of the Clarient Insight Dx profile achieved significantly higher classification accuracy than current clinical practice treatment guidelines to aid selection of the most appropriate level of adjuvant therapy in patients with operable breast cancer.

"We are very excited that these published results validate our Clarient Insight Dx Breast Cancer Profile," said [ Ron Andrews ], Clarient's Chief Executive Officer. "Through our initial trials in conjunction with Prediction Sciences, the data has demonstrated that we can better assess breast cancer recurrence and death risk, and potentially reduce the need for chemotherapy in a substantial population of women who are affected by breast cancer."

About the Study

Patients with operable hormone-receptor-positive breast cancer were diagnosed at hospitals associated with the University Hospital Basel, Switzerland, and the Institut Paoli-Calmettes, Marseille, France. They were treated adjuvantly as follows: 90 untreated, 290 hormone therapy only, and 119 chemotherapy plus hormone therapy. Investigators used immunohistochemistry to score seven protein markers (ER, PR, Her2, EGFR, BCL2, p27/Kip1, and p53) and fluorescence in situ hybridization to score one genomic marker (MYC/8q24) in tumor cells in tissue sections. Risk scores on a scale of 0 to 10+ were generated for each patient using an algorithm that combined these molecular markers scores with tumor size, tumor grade, and nodal status. In the hormone therapy treated patients, the profile achieved a negative predictive value of 96% for metastasis within 10 years and 97% for disease-specific survival within 8 years, with corresponding positive predictive values of 35% for metastasis and 27% for disease-specific survival. Within a set of patients identified as high-risk by Adjuvant! Online, the profile reclassified as low risk 85% of pN0 patients and 43% of pN1 patients. In these patients, less than 10 percent experienced metastasis at 10 years, and less than five percent experienced disease-specific survival events, indicating that such patients would be candidates to be spared from cytotoxic chemotherapy.

Commenting on the study results, [ Dr. Kenneth Bloom ], Clarient's Chief Medical Officer said, "Clarient's mission is to bring clarity to the complexity of cancer. We are very excited to arm physicians with a tool that will aid them in evaluating the recurrence risk of breast cancer patients. We believe that Clarient Insight Dx significantly enhances a pathologist's ability to predict this recurrence risk in ER-positive breast cancer patients, ultimately driving us to achieve our goal."

Andrews added, "The presentation of the data in a peer reviewed format supports the medical validity of the markers chosen and their ability to identify and stratify risk. This marker set has now been validated by Clarient in subsequent trials and those data will be published in the coming months as Clarient continues the launch phase of the Clarient Insight Dx Breast Cancer Profile."

About Clarient

Clarient combines innovative diagnostic technologies with world class 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. 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 diagnostic services available both onsite and over the web. The Company is also developing new, proprietary "companion" diagnostic markers for therapeutics in breast, prostate, lung and colon cancers, and leukemia/lymphoma. Clarient is a Safeguard Scientifics, Inc. partner company. [ www.clarientinc.com ]

About Safeguard Scientifics

Founded in 1953 and based in Wayne, PA, Safeguard Scientifics, Inc. (NYSE:SFE) provides growth capital for entrepreneurial and innovative technology and life sciences companies. Safeguard targets technology companies in Software as a Service (SaaS) / Internet-based Businesses, Technology-Enabled Services and Vertical Software Solutions, and life sciences companies in Molecular and Point-of-Care Diagnostics, Medical Devices and Specialty Pharmaceuticals with capital requirements between $5 and $50 million. Safeguard participates in expansion financings, corporate spin-outs, management buyouts, recapitalizations, industry consolidations and early-stage financings. [ www.safeguard.com ]

About Prediction Sciences

Prediction Sciences, a La Jolla, California-based company, develops high-value molecular diagnostics for disease detection, prognosis and treatment outcome for indications of high unmet clinical need. Prediction Sciences partners with reference laboratories and academic institutions in the U.S. and abroad to provide tests in oncology and cardiovascular indications to enable personalized medicine.

Forward-Looking Statements

The statements herein regarding Clarient, Inc. (the "Company") 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: the Company's ability to market and fund continued development ofthis new genomics-based diagnostic test for prostate cancer,the Company's ability to obtain third party payer reimbursement for this test, the efficacy of the test once introduced in the marketplace and the acceptance of this test by physicians and patients,failure to obtain any requisite regulatory clearances or approvals, the Company'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.