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CAP Today




May 2011

Clearstone and Mitsubishi partner

Clearstone Central Laboratories, a provider of lab services for late-stage clinical trials, has entered into a provider relationship with Mitsubishi Chemical Medience Corp.

The partnership will provide both companies’ clients with seamless access to CAP-accredited laboratories for safety and specialty testing services throughout the Asia-Pacific region and worldwide.

Included are Clearstone’s laboratory in China and its global laboratory network. Clearstone’s customers will be able to tap into Mitsubishi’s laboratory network in Japan.

Clearstone’s chief executive officer Lewis Cameron said the relationship between Clearstone and Mitsubishi Chemical Medience has developed over the past year.

In August, Clearstone announced a global collaboration with the Esoterix Clinical Trials Services division of LabCorp and opened a network of CAP-accredited central laboratories in Belgium, Canada, China, France, Singapore, and the United States, while creating a large biomarker assay portfolio.

Cancer survivors in ’07: 11.7 million

The number of cancer survivors in the United States increased to 11.7 million in 2007, according to a Centers for Disease Control and Prevention and National Cancer Institute report. There were 3 million cancer survivors in 1971 and 9.8 million in 2001. A cancer survivor is defined as anyone who has been diagnosed with cancer, from the time of diagnosis through the balance of his or her life.

The study, “Cancer Survivors in the United States, 2007,” was published March 10 in the CDC’s Morbidity and Mortality Weekly Report.

To determine the number of survivors, the report’s authors analyzed the number of new cases and followup data from the NCI’s Surveillance, Epidemiology and End Results Program between 1971 and 2007. Population data from the 2006 and 2007 U.S. Census were also included. The researchers estimated the number of people ever diagnosed with cancer (except non-melanoma skin cancers) who were alive on Jan. 1, 2007.

Study findings indicate that of the 11.7 million people living with cancer in 2007, 7 million were age 65 or older. Women make up a large proportion of cancer survivors (54 percent). Breast cancer survivors are the largest group of cancer survivors (22 percent), followed by prostate cancer survivors (19 percent) and colorectal cancer survivors (10 percent). Among all survivors, 4.7 million received their diagnosis 10 or more years earlier.

The study’s authors note that the increase in number of cancer survivors is due to many factors, including a growing aging population, early detection, improved diagnostic methods, more effective treatment, and improved clinical followup after treatment.

For the full report, visit

New tool for developing cancer drugs, diagnostics

Rules-Based Medicine recently launched OncologyMAP, a tool that measures 101 cancer-related proteins, thus providing researchers with data on biological pathways to help understand the molecular basis of cancer. OncologyMAP was developed at the direction of and with funding from the National Cancer Institute and released in October to a limited number of customers. RBM has since received positive feedback from clients who report valuable results in their studies for drug re-tasking, indication expansion, and patient stratification using the comprehensive testing service.

OncologyMAP provides drug researchers with an accurate and affordable means of evaluating the efficacy and safety of therapeutic candidates. The test is validated to clinical laboratory standards, enabling biomarker pattern discoveries made in basic research to be reproducibly extended into clinical trials.

OncologyMAP is based on RBM’s proprietary multi-analyte profiling (MAP) platform, which quantifies key blood-based biomarkers representing dozens of important biological pathways. The multiplexing process allows for heightened efficiency while providing excellent accuracy and precision.

LabCorp acquires Orchid

LabCorp will buy DNA testing services company Orchid Cellmark in a deal valued at $85.4 million. The agreement calls for LabCorp to acquire all outstanding Orchid shares for $2.80 per share.

LabCorp said the acquisition strengthens its presence in identity testing in the United States while also giving it a presence in the United Kingdom, where Orchid also operates. Princeton, NJ-based Orchid reported revenue of $63.7 million in 2010.

Orchid’s board of directors approved the deal and merger plan, determining that the offer and merger are “advisable, fair to, and in the best interests of Orchid Cellmark and its stockholders.”

Orchid is LabCorp’s second acquisition in recent months. The company completed in December its $925.2 million acquisition of Genzyme Genetics, a deal LabCorp made to advance its personalized medicine strategy.

CAP accredits Pathwork

Pathwork Diagnostics’ laboratory recently received CAP accreditation. The company’s gene expression-based Tissue of Origin test helps identify the origin of metastatic and poorly differentiated tumors.

Samuel K. Caughron, MD, director of molecular pathology, MAWD Pathology Group, North Kansas City, Mo., said: “CAP accreditation of the Pathwork Diagnostics laboratory assures patients and physicians that specimens sent for the Tissue of Origin test are processed with meticulous quality control and in accord with best established practices for laboratory medicine.”

In addition, the laboratory is now CLIA-certified. In 2010, the laboratory received a clinical laboratory permit from the New York State Department of Health, establishing the Tissue of Origin test as an FDA-cleared tissue-of-origin testing service in New York. The Florida Society of Clinical Oncology recently endorsed the test.

Physician-hospital relationships

About three-fourths of physicians surveyed by PricewaterhouseCoopers’ PWC Health Research Institute said they have aligned financially with hospitals through employment, joint ventures, or directorships, and 58 percent said they wanted to move toward even closer financial relationships with hospitals, according to a report found in the February 2011 issue of Hospitals & Health Networks.

Sixty-three percent of cardiology specialists were interested in hospital employment compared with 48 percent of primary care physicians and 45 percent of all other specialists. Orthopedists were least interested.

Though cardiology has been among the most lucrative of the specialties, institute researchers noted it has experienced the deepest cuts in Medicare payments. Asked why they wanted to align with hospitals, physicians cited relief from growing financial and administrative burdens and fear of income loss in anticipation of reimbursement cuts.

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