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Pall, GeneSystems, International Serious Adverse Events Consortium, Cerner, Health Discovery Corp, Smart Personalized Medicine, XDx, US Food and Drug Administration, DiagnoCure, Center for Medicare and Medicaid Services

Pall Acquires French Molecular Dx Firm
Pall said this week that it has acquired French molecular diagnostics firm GeneSystems for an undisclosed sum.
Bruz, France-based GeneSystems has developed a real-time PCR-based molecular diagnostics platform for rapid microbial detection. The firm offers tests for a range of pathogens including Legionella and E. coli.
Pall said the acquisition will expand its Total Fluid Management capabilities in the biopharmaceutical process monitoring market, which it estimated to be worth $1 billion. The East Hills, NY-based firm said that it also would provide it with new opportunities in the environmental, food and beverage, and water markets.

SAEC, Cerner to Study Genetic Markers for Adverse Drug Effects
The International Serious Adverse Events Consortium said last week that it will collaborate with electronic medical records provider Cerner on identifying genetic markers to help predict individuals who are at risk for a range of serious drug-related adverse events.
The consortium, which was founded a year ago , said it will explore the feasibility of diversifying its methods for developing serious adverse event research cohorts. The alliance with Cerner will focus on three SAEs: hepatoxicity, serious skin rashes, and cardiac dysfunctions, such as prolonged QT.
“By working with third party EMR providers such as Cerner, we hope to open up a new, more scalable research channel to enroll subjects into this vital research,” Arthur Holden, chairman of the SAEC, said in a statement. “Our goal is to increase the breadth and diversity of patients participating and to provide our clinical research collaborators with larger, more developed research cohorts in a more efficient and effective manner.”

HDC Takes 15 Percent Stake in Smart Personalized Medicine
Health Discovery Corp. said last week that it has taken a 15 percent equity stake in Smart Personalized Medicine, a prognostic test start-up founded by Richard Caruso, a former HDC board member and chairman and founder of Integra Life Sciences.
HDC said last week that Caruso had resigned his position as a board member to negotiate a license to use the firm’s support vector machine technology in developing a breast cancer prognostic test.
In addition to the equity stake, HDC will receive a 7.5 percent per-test royalty based on net proceeds from sales of the breast cancer prognostic test, Savannah, Ga.-based HDC said.

XDx Gets FDA OK for Heart Transplant Molecular Dx Test
XDx announced last week that the US Food and Drug Administration has cleared for marketing the firm’s AlloMap multi-gene molecular expression test for heart transplant patients.
The non-invasive test is used in conjunction with standard clinical assessment to aid physicians in identifying heart transplant recipients with stable allograft function who have a low probability of moderate to severe acute cellular rejection at the time of testing. The AlloMap test includes 11 rejection biomarker genes and nine control genes, said XDx.
The Brisbane, Calif.-based firm noted that it is the first company to receive FDA clearance of an In Vitro Diagnostic Multivariate Index Assay for use in transplant management. It is the third such assay clearaed by the agency, following the February 2007 clearance of Agendia’s MammaPrint test and Pathwork Diagnostic’s Tissue of Origin test last month.
“This clearance and the FDA’s focus on this field underscore the growing importance of molecular diagnostics in the care of patients,” XDx President and CEO Pierre Cassigneul said in a statement.
XDx has been offering the test through its CLIA-certified lab since January 2005. The firm said the test was validated using data from nine heart transplant centers participating in the Cardiac Allograft Rejection Gene Expression Observational study.

DiagnoCure Oncology Gains CLIA Certification for Colorectal Cancer Test
DiagnoCure Oncology Laboratories said last week that its colorectal cancer staging test has been certified for marketing in the US by the Center for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments.
DiagnoCure Oncology Laboratories, a West Chester, Penn.-based subsidiary of the Canadian company DiagnoCure, said that now that the Previstage GCC Colorectal Cancer Staging Test has been CLIA certified the company can promote it, perform it in its US lab, and promote the results worldwide.
DiagnoCure President and CEO John Schafer in a statement called the certification “a major accomplishment” in the company’s growth strategy that will “strengthen our leadership position in high-value molecular cancer diagnostics.”
The company said that each year in the US 174,000 people are diagnosed with colorectal cancer, and 142,000 cancer removal surgeries are performed.
Staging colorectal cancer patients is crucial, the company said, because it determines the course of treatment after surgery. Now, that method requires that pathologists examine a thin slice of lymph node tissue to see if the cancer has spread. As many as 25 percent to 30 percent of patients without stage one and stage two cancers in the lymph nodes later have recurrences of the disease.
“We can help answer the fundamental question that every colorectal cancer patient asks after their surgery: Am I cured or has my cancer spread?" Schafer added.

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