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Clarient Granted Exclusive License to Commercialize Breast Cancer Biomarker by Indiana University Research and Technology Corporation

Posted on: Thursday, 23 April 2009, 05:00 CDT

FOXA1 biomarker predicts likelihood of recurrence and long-term disease-free survival of breast cancer patients; Further strengthens Company's breast cancer menu

ALISO VIEJO, Calif., April 23 /PRNewswire-FirstCall/ -- Clarient, Inc., (Nasdaq: CLRT), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists and the pharmaceutical industry, today announced that it has been granted an exclusive intellectual property license from the Indiana University Research and Technology Corporation (IURTC) for the rights to commercialize the FOXA1 biomarker, which predicts the likelihood of recurrence and long-term, disease-free breast cancer survival. The licensing of this intellectual property further strengthens Clarient's deep menu of molecular tests for breast cancer and will complement the Clarient Insight(R) Dx Breast Cancer Profile, which is expected to be released soon.

The FOXA1 marker, also known as forkhead box A1, is a gene known to cause breast cancer. Recent data presented at the 2009 USCAP (United States and Canadian Academy of Pathology) meeting demonstrated that the expression of FOXA1, now known to be an estrogen receptor associated transcription factor, correlated with Oncotype Dx(R) when performed in patient samples from Indiana University. In this clinical study of 79 ER-positive, node-negative breast cancer patients, researchers found that FOXA1 expression identified the same low risk, ER-positive, node-negative patients who can be spared toxic chemotherapy (P=0.002). Researchers concluded Oncotype Dx and the FOXA1 marker can potentially be used interchangeably if further validation studies confirm the findings.

Clarient CEO Ron Andrews noted that FOXA1 has shown it can predict risk of cancer recurrence in ER-positive, node-negative breast cancer patients. "Licensing FOXA1 and better understanding what advantages it might have over competitive tests will help put this marker on a rapid commercial track and support our mission to determine the most effective and reliable ways to evaluate breast cancer recurrence in women with early stage disease. Clearly, this marker is a tremendous addition to Clarient's rich menu in breast cancer," Andrews said. "It is also a significant new addition to our Clarient Insight Dx program, which aims to provide pathologists and oncologists with a panel of assays that help deliver personalized medicine in the community setting. Our dedication to translating cancer discovery and information into enhanced patient care is evidenced by our ability to license such coveted IP from prestigious institutions."

"FOXA1 has also demonstrated an ability to differentiate between unique sets of breast cancer characteristics, which include luminal A and B subtypes," said Ken Bloom, M.D., Clarient's Chief Medical Officer.

"Recent gene expression profiling studies have classified breast cancer into five distinct subtypes with unique molecular characteristics and prognostic significance," Dr. Bloom said. "Although both luminal subtype A and B correspond to ER-positive breast cancers, we have always known that luminal A subtype patients are associated with a significantly better prognosis in breast cancer. Clarient's agreement to license FOXA1 from IURTC provides for another strong marker to help identify these luminal A subtypes."

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. 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 Oak Investment Partners

Oak Investment Partners is a multi-stage venture capital firm with a total of $8.4 billion in committed capital. The primary investment focus is on high growth opportunities in Healthcare Information and Services, Information Technology and Software Outsourced Services, Consumer Internet/New Media, Financial Services Technology, Clean Energy, Broadband Internet and Wireless Communications, and Retail. Over a 30-year history, Oak has achieved a strong track record as a stage-independent investor funding more than 481 companies at key points in their lifecycles. Oak has been involved in the formation of companies, funded spinouts of operating divisions and technology assets, and provided growth equity to mid- and late-stage private businesses and to public companies through PIPE investments. Representative Oak healthcare investments include Genzyme Corporation, Cephalon, ViroPharma, American Esoteric Laboratories, athenahealth, Psychiatric Solutions, and United BioSource Corporation. www.oakinv.com

About Safeguard

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), Technology-Enabled Services and Internet-based Businesses, 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

Forward Looking Statements

Certain 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: the Company's ability to continue to develop and expand its diagnostic services business, uncertainty of success in identifying and developing new diagnostic tests or novel markers, the Company's ability to fund development of new diagnostic tests and novel markers and the amount of resources the Company determines to apply to novel marker development and commercialization, failure to obtain FDA clearance or approval for particular applications, 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.

Contact: Matt Clawson Allen & Caron Inc (949) 474-4300 matt@allencaron.com

SOURCE Clarient, Inc.

Source: PR Newswire

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