July 1, 2008
Clarient Launches New Colorectal Cancer Test
ALISO VIEJO, Calif., July 1 /PRNewswire-FirstCall/ -- Clarient, Inc. , a premier anatomic pathology and molecular testing services resource for pathologists, oncologists, and the pharmaceutical industry, today announced its new offering, KRAS, which has been validated as a laboratory-developed test to be used as a predictive molecular biomarker for patients with colorectal cancer (CRC). The importance of KRAS testing was recently reported at this year's ASCO meeting in Chicago and is supported by data published in the Journal of Clinical Oncology (JCO) in April 2008.
Ron Andrews, Clarient's Chief Executive Officer said, "Identifying the KRAS mutation can help individual patients and their physicians understand the best way to manage their disease, assisting them in selecting the most appropriate therapy. There are more than 150,000 patients diagnosed with colorectal cancer each year, many of whom must decide whether anti-EGFR treatments will be used to manage their disease."
In colorectal cancers, EGF-receptors transmit a series of signals through a complex path of intracellular proteins. These signals ultimately instruct the cancer cell to undergo a transcription process leading to cancer progression. Anti-EGF-receptor therapies such as panitumumab (Vectibix(TM), Amgen) and cetuximab (Erbitux(TM), ImClone Systems) work by blocking the activation of EGF-receptor. By blocking activation of the receptor, these drugs are successful in inhibiting downstream events that lead to malignant signaling. KRAS is located downstream of EGF-receptor and is a vital component in orchestrating this signaling process. It is now understood that mutations in the KRAS gene impact the protein function such that its signaling process is always turned "on," regardless of whether the EGFR has been activated or therapeutically inhibited. Mutations in the KRAS genes have been detected in about 40 percent of metastatic colorectal cancer patients.
"The recently published data set further validates the importance of identifying molecular markers to help predict therapeutic responses in individual patients. These discoveries are a major step forward in advancing the field of personalized cancer care," said Ken Bloom, M.D., Chief Medical Officer at Clarient. "The high frequency of this mutation along with the clinical utility of this assay suggests that it has the potential of being applied to virtually all colon cancer cases."
Bloom continued, "Furthermore, our ability and approach at Clarient -- to understand key oncogenic pathways and how they interact as therapies are applied to patients -- will allow us to develop additional tests for a range of cancer indications."
Andrews added, "This and other upcoming biomarker introductions illustrate how science and the Clarient business model work in harmony. The accuracy of gene tests like KRAS is improved when only the cancer cells of interest are chosen for analysis. Clarient is the only lab in the industry that allows community-based pathologists to select the cells of interest via our internet-based virtual microscopy solution, insuring that the most accurate KRAS results are obtained. KRAS is an outstanding addition to our extensive test menu. We are proud to be a leader in offering the latest in cancer diagnostic testing, allowing patients to avoid unnecessary toxicities, treatment delays, and higher overall cost of therapy."
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/
Founded in 1953 and based in Wayne, PA, Safeguard Scientifics, Inc. 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. 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: acceptance of the KRAS offering in the marketplace and among pathologists and patients, efficacy of the KRAS test as a predictive molecular biomarker, the Company's ability to continue to develop and expand its diagnostic services business, the Company's ability to expand and maintain a successful sales and marketing organization, unanticipated expenses or liabilities or other adverse events affecting cash flow, 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, the Company's ability to obtain additional financing if required on favorable terms or at all, 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 [email protected]
CONTACT: Matt Clawson of Allen & Caron Inc, +1-949-474-4300,[email protected], for Clarient, Inc.
Web site: http://www.clarientinc.com/