Healthcare Industry News: HER2
News Release - May 5, 2009
Clarient Launches New Breast Cancer TestThe Clarient InsightŪ Dx Breast Cancer Profile Assists Physicians In Identifying Recurrence Risk and the Need for Chemotherapy
ALISO VIEJO, Calif., May 5 (Healthcare Sales & Marketing Network) --Clarient, Inc. (Nasdaq: CLRT ), a premier anatomic pathology and molecular testing services resource for pathologists, oncologists and the pharmaceutical industry, today announced the commercial launch of a new breast cancer test that helps physicians identify the probability of a patient's cancer recurring and assess the need for chemotherapy. The new prognostic test, Clarient Insight(R) Dx Breast Cancer Profile, has been clinically validated for women with early-stage, hormone-receptor-positive breast cancer. Unlike other assays used to determine the likelihood of recurrence, the Clarient Insight Dx Breast Cancer Profile uses a combination of pathology risk factors and molecular markers to categorize patients as either high or low risk.
In 2008, approximately 205,000 people in the United States and 1.3 million people worldwide were diagnosed with breast cancer. Many of these patients are diagnosed as early-stage, hormone-receptor positive breast cancer patients who are faced with the critical decision of whether or not to undergo chemotherapy.
"If you have breast cancer, you want to know if your cancer will recur, and if chemotherapy is the right treatment for you," says Ken Bloom, M.D., Chief Medical Officer for Clarient. "Our laboratory-developed test helps pathologists, oncologists and patients make better informed, more personalized treatment decisions. We believe that pathologists are uniquely trained to understand the complex puzzle of testing that makes up the diagnosis and prognosis of cancer. Delivering a panel of well-characterized and well-published markers combined with traditional clinicopathological information to our network of pathologists will take some of the mystery out of the decisions oncologists and their patients have to make."
The Clarient Insight Dx Breast Cancer Profile combines three traditional pathology staging risk factors with seven key molecular markers. Staging factors are tumor size, tumor grade, and lymph node status. Molecular markers include ER, PR, HER2, EGFR, BCL2, p53, and MYC. The information is then combined with a proprietary algorithm to produce a risk score that assists pathologists and oncologists in clinical decision-making.
"With the launch of the Clarient Insight Dx Breast Cancer Profile, we move one step closer to fulfilling our vision of transforming breast cancer from a deadly disease to a chronic disorder," says Ron Andrews, CEO of Clarient. "Despite other offerings in the marketplace, there is a huge unmet need for women with this type of cancer. At Clarient, we currently perform a range of prognostic testing such as ER, PR and HER2, and we also have a deep menu of molecular pathway tests that enable pathologists to ascertain a thorough understanding of each individual tumor. The ability to now further test these patients for risk of recurrence strengthens our service offering to our pathology clients, as well as enhances our overall competitive position in the breast cancer testing market."
Clarient conducted an independent study using a set of breast cancer patients from the Royal Perth Hospital in Western Australia to clinically validate the Clarient Insight Dx Breast Cancer Profile. The algorithm demonstrated an accurate, actionable risk recurrence score. In the study, high- and low-risk patients were identified using the Clarient Insight Dx Breast Cancer Profile. The low-risk group had only a 3 percent recurrence rate 10 years after surgery. This is equivalent to a negative predictive value of about 97 percent, and the corresponding positive predictive value was 39 percent. In studies completed to date, Clarient's test also outperformed the commonly used and well-regarded Adjuvant! Online cancer treatment assessment tool, accurately identifying about 25 percent more low-risk patients. To review additional information on the Clarient Insight Dx Breast Cancer Profile and the data produced during the clinical validation testing, please visit http://www.clarientinc.com/insightdx.
Clarient's results also correlated with the earlier validation findings of Prediction Sciences, the exclusive licensor of Clarient Insight Dx Breast Cancer Profile. Prediction Sciences studied the profile's performance in several independent trials, and presented its findings in the International Journal of Cancer in February 2009 and at the San Antonio Breast Cancer Symposium in December 2008. In the development of this profile, more than 1,000 patient results have now been analyzed.
"Our initial marketing efforts will be focused on educating our network of community pathologists on the value of this additional information to clinicians and their patients," commented Andrews. "Our full marketing efforts will now commence, and while we expect that it will take some time for additional papers and publications to unfold, we believe we will begin to see revenue traction for the new test by fall of this year."
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. 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 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 Internet / New Media, Financial Services IT and Healthcare IT, and life sciences companies in Molecular and Point-of-Care Diagnostics, Medical Devices, Regenerative Medicine and Specialty Pharmaceuticals with capital requirements between $5 million 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
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
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.
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