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Agendia, Affy, Gentris, Falco, TGen, NIH, Bio-Reference Labs, GeneDx

Two Recent Studies Validate Agendia's MammaPrint …
TRANSBIG (Translational Research Breast International Group), a European research consortium, has published a study that validates the clinical utility of Agendia’s Mammaprint breast cancer prognosis test, the company said this week.
The study followed on the heels of a study published in the Aug. 10 issue of the New England Journal of Medicine, which showed that MammaPrint and three other multi-gene tests are “superior over conventional assessment of risk of future metastatic disease,” the company said in a statement.
The authors of the NEJM study found that even though multi-gene tests have only minimal overlap in the genes used, “they show a remarkable agreement in assigning patients to the same risk category,” Agendia said.
The TRANSBIG study, published in the online version of the Journal of the National Cancer Institute on Sept. 6, found that the MammaPrint 70-gene signature “clearly outperformed the clinico-pathological risk assessment in predicting disease outcome” and concluded that the test “adds independent prognostic information to clinico-patholoigcal risk analysis in early breast cancer,” Agendia said.
In that study, 307 breast cancer patients from five different European centers were compared for their risk for metastatic disease either by MammaPrint test or by conventional clinico-pathological risk assessment as determined by the Adjuvant! software.

… As the Firm Receives ISO Accreditation for CupPrint
Agendia said this week that it has acquired ISO/IEC 17025:2005 accreditation for its CupPrint microarray service from the Dutch Accreditation Council.
The company was granted ISO 17025 accreditations for its MammaPrint breast cancer diagnostic, in September. According to Agendia, it is the first company to receive this accreditation for the test.
CupPrint is a test for cancer of unknown primary.

Affy to Provide Genotyping Services for SHARE Heart Study
The SNP Health Association Resource (SHARE) project has selected Affymetrix to provide genotyping services for a large-scale whole-genome association study to identify SNPs associated with heart, lung, blood, and sleep disorders, Affy said this week.
As part of the SHARE project, Affy, along with the National Heart, Lung, and Blood Institute and the National Center for Biotechnology Information, will analyze more than 9,000 samples collected by NHLBI and Boston University for the Framingham Heart Study, a decades-old database comprising more than 15,000 patient samples related to cardiovascular disease.
In addition, researchers will develop a database that will integrate genotypic information with phenotypic information from multiple NHLBI studies, Affy said. The data will be made available to the scientific community for further genome-wide association studies and will complement data included in the Affymetrix Control Program, the company said.
Financial details were not disclosed.

Gentris, Falco Partner to Create Japan's first GLP-Compliant PGx Lab
Gentris has entered into an exclusive 10-year agreement with Kyoto-based Falco Biosystems to develop Japan’s first Good Laboratory Practice-compliant pharmacogenomics laboratory.
The partnership will be called “Gentris Japan.” Japan is the world’s second-largest pharmaceutical market after the US, Gentris said, adding drug companies in the country are increasingly looking to add pharmacogenomics into their drug-development programs. 
Gentris is based in Research Triangle Park, NC and provides applied clinical pharmacogenomic services and diagnostic products, the company said.

TGen, Partners to Use Affy Chips to Study Genetic Underpinnings of Age-Related Hearing Loss
Researchers at the Translational Genomics Research Institute and the House Ear Institute have begun a study that will use Affymetrix GeneChips to identify the genes and genetic interactions involved in presbycusis, or age-related hearing loss, TGen said last week.
The researchers will use Affy’s 500K SNP chips to study nearly 2,000 patient samples collected at the Hereditary Deafness Laboratory at the University of Antwerp, Belgium. A short-term goal of the study is to create a screening chip to identify variations in specific genes that lead to presbycusis, TGen said.
According to the National Institutes of Health, around 30 percent to 35 percent of adults between the ages of 65 and 75 years experience presbycusis, and 40 percent to 50 percent of people 75 years and older suffer from hearing loss.
"This study will serve as a foundation for gene discoveries in other complex diseases and provides the groundwork for early diagnosis and treatment of age-related hearing loss," said Rick Friedman, principal investigator of the study at the House Ear Institute, in a statement.

NIH, Seeking to Harmonize Genome-Association Studies, Wants to Centralize Certain Genotype, Phenotype Data
The US National Institutes of Health is considering harmonizing NIH-funded genome-wide association studies by corralling all genotypic and phenotypic data from these studies into a central government repository.
Several NIH institutes have either recently launched or plan to start these studies with the “expectation” that the studies will accelerate drug and diagnostic development, especially for “individualized preventive medicine,” according to Director Elias Zerhouni.
“As numerous [genome-wide association studies] … get underway, NIH seeks to harmonize the policies by which the results will be made available to researchers,” the NIH said in a statement.
The proposed policy would ask NIH-funded investigators performing genome-wide association studies to “quickly submit” subjects' genotypes and “relevant phenotypes” to a centralized NIH data repository.
In the statement, the NIH said that these data “will be submitted in a form that protects the privacy and confidentiality of research participants,” and that they “will be made freely available to all approved researchers to accelerate their studies.”
However, the NIH said that while it “encourages patenting of intellectual property,” the agency “seeks to prevent premature or inappropriate patents that impede future research.” The NIH did not define what it considers “premature” or “inappropriate” patents, or explain what it would do to “prevent” these from being issued.
"The NIH believes that the various and complex interests related to the submission of, and access to, [genome-wide association study] data must be discussed with the public," Elizabeth Nabel, director of National Heart, Lung, and Blood Institute and head of the NIH-wide team developing the policies, said in the statement.
The NIH said it will ask the public to discuss issues such as participant privacy concerns, potential risks and benefits for individual participants, professional recognition of investigators, and intellectual property rights.
The public has until Oct. 31 to comment. The request for information is available here and comments can be submitted here.
The NIH said it also plans to hold a town hall meeting in early December.

Bio-Reference Labs, Buying GeneDx, Will Consider Entering PGx Space
Bio-Reference Laboratories said that it plans to acquire specialty testing shop GeneDx and will consider expanding into pharmacogenomics testing.
Entering the molecular diagnostics market, including the drug-monitoring space, is one option that is “on the table,” Amar Kamath, marketing director for Bio-Reference’s molecular business, told Pharmacogenomics Reporter sister publication GenomeWeb News last week.
Bio-Reference said it plans to acquire GeneDx for as much as $17 million. The deal, expected to close by mid-September, will “represent a major new initiative for our company,” Bio-Reference CEO Marc Goodman said in a statement.
Kamath said management from both companies will meet over the next few weeks to “hash out” Bio-Reference’s options once GeneDx is on board, and may by the end of September have a better idea of where the company wants to go in relation to pharmacogenomics.
”We haven’t ruled anything out,” Kamath said. “All options are on the table.”
GeneDx, based in Gaithersburg, Md., uses DNA sequencing technologies to perform genetic tests for a large number of rare disorders. The company markets its services to physicians and patients.
GeneDx generated “just short” of $5 million in revenue in 2005, and receipts this year have grown 35 percent, Bio-Reference said.

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