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FDA Will Release Pharmacogenomics Guidance on Friday, Agency Officials Say

The US Food and Drug Administration will release its Guidance for Industry on Pharmacogenomic Data Submissions on Friday, according to two agency officials.

Larry Lesko, director of the office of clinical pharmacology and biopharmaceutics at the FDA's Center for Drug Evaluation and Research, announced the day during a presentation at a Drug Information Association conference in Lisbon, Portugal, last week. Lesko and Felix Frueh, CDER's associate director for genomics, both confirmed the date through an FDA spokesperson last Friday.

The long-awaited document will appear on a special website that the FDA will launch this week, Federico Goodsaid, an official at the agency's Office of Clinical Pharmacology and Biopharmaceutics, said during a lecture at the Society of Toxicology meeting in New Orleans last week.

During his presentation, Goodsaid said the FDA will release the final guidance "within a week or two."

The document, whose approval has been delayed numerous times since it was released as a draft in November 2003, may serve to encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts, and submit some of their findings as a way to help the FDA broaden its knowledge of the technologies.


Oxford Genome Sciences to Evaluate Bayer Diagnostics' Breast Cancer Biomarkers

Oxford Genome Sciences will use its proteomics platform and its Oxford Genome Anatomy Project to evaluate biomarkers linked to breast cancer for Bayer HealthCare's diagnostics division, the companies said this week.

Though financial terms of the agreement were not disclosed, Bayer said it "has committed program funding" to Oxford, and agreed to performance-related payments upon achieving certain milestones.

Bayer HealthCare hopes this research will help it discover and develop therapeutic and diagnostic products for breast cancer.

According to Oxford, the OGAP proteomics database has more than 1 million peptide sequences from approximately 50 different tissues involved in almost 60 different diseases mapped onto 15,000 human genes.


Genaissance Ally Ipsogen Opens Office in Connecticut

Marseille, France-based Ipsogen announced this week that it has recently opened an office in the US, located in Windsor, Conn.

The company is sharing office space with another undisclosed biotechnology firm according to a company representative.

Ipsogen said the new office will support its FusionQuant, ProfileQuant, and FusionChip products, as well as several new molecular tests. Iposgen also has co-marketing alliances with Genaissance for gene-expression and genotyping technologies, and is an authorized service provider for Affymetrix's GeneChip technology.


Illumina Promises Million-SNP Genotyping Product for Summer 2006

Illumina plans to release a genotyping product by June 2006 that will allow researchers to analyze one million SNPs, the San Diego-based company said this week.

The product, based on a pair of Sentrix BeadChips, will use the company's Infinium assay, which does not rely on PCR. Before it launches the one-million-SNP product, Illumina plans to release BeadChips containing 250,000 and 500,000 SNP markers.

Illumina will work with a customer consortium to determine the SNP content of the BeadChips.


GE Healthcare to Relocate Imaging Research Business to NJ from Canada

GE Healthcare will relocate Imaging Research, the Ontario-based bioinformatics and screening company it acquired with Amersham, to Piscataway, NJ, later this month, GenomeWeb News, a Pharmacogenomics Reporter sister publication, has learned.

The company, which employed 45 staffers as of December 2003, will formally shut down its St. Catharines, Ontario, facility before the end of the month, according to people familiar with the event. Amersham acquired Imaging Research in 2003, and GE Healthcare bought Amersham one year later.

A telephone call placed to Imaging Research was routed to a general company mailbox. The mailbox still identifies the company as Amersham Biosciences Niagara.

GE Healthcare did not immediately return a telephone call seeking comment.

According to Imaging Research's website, the company's products and services include laboratory-imaging systems and gene expression-analysis software, such as the ArrayVision software for the quantifying gene-expression arrays, and ArrayStat, which analyzes expression array data.

The company also sells ultra-high throughput screening platforms, such as LEADseeker, and the IN Cell Analyzer 1000 automated cell-screening system. Imaging Research said "both of these enabling technologies are licensed exclusively to Amersham Biosciences," which was acquired by GE in April 2004.

On Imaging Research's website, GE is listed as a US and Canadian distributor for its products. Other countries in which the company's products are sold include France, Germany, Japan, Korea, the Netherlands, and Taiwan.


Perlegen Wins Grant for Whole Genome Study of Rheumatoid Arthritis

Perlegen will conduct a whole-genome study of rheumatoid arthritis under a grant for an undisclosed amount from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.

The study will use DNA samples from rheumatoid arthritis patients provided by the North American Rheumatoid Arthritis Consortium, which is supported by the National Institutes of Health, and the National Arthritis Foundation.

Peter Gregersen, head of the center of genomics and human genetics at the Institute for Medical Research of the North Shore Long Island Jewish Health Systems, and principal investigator of the NARAC, will serve as an advisor to the study, Perlegen said.

Additional details of the research were not disclosed.

 

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