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BioArray Briefs: 2009.04.07


CGC Genetics Gets California Clinical Lab License

CGC Genetics, a Portugal-based medical genetics lab firm, this week said that it recently gained a Clinical Laboratory License from the State of California.

The company said that the license would enable it to resume previous collaborations with California institutions. CGC provides genetic diagnostic testing with a specialty in rare diseases, and runs microarray-based tests.

The firm was one of 13 lab operators that received a notice from the California Department of Public Health last June ordering the labs to cease offering genetic testing services without a license from the state or a physician order. The letters were in response to the growing number of firms offering genetics scans directly to consumers.

However, CGC has pointed out that it does not offer tests directly to consumers.

Nuvera Biosciences Licenses PGx Assays to Veridex

Nuvera Biosciences has licensed pharmacogenomic assays that it has developed to Veridex, which will commercialize the tests.

The multi-gene assays were developed for predicting patient response to tamoxifen therapy and taxane-containing chemotherapy in breast cancer. Woburn, Mass.-based Nuvera developed the assays in collaboration with the University of Texas MD Anderson Cancer Center.

Under terms of the agreement, Veridex, which is a Johnson & Johnson company, will pay Nuvera an upfront fee, milestone payments over the next several years based on commercialization and revenues, and royalties on sales. Nuvera said that it will continue to support test validation through its expertise in diagnostics and bioinformatics and through its partnerships with MD Anderson and other cancer centers.

Veridex also will complete clinical studies on the tests and intends to commercialize the assays worldwide.

"We believe the uniqueness of our tests is not just their therapy-directed focus but that they can potentially be combined with Veridex tests into a single test platform that could enable important, effective decisions from a single tumor sample," Nandan Padukone, president and CEO of Nuvera, said in a statement.

ImaGenes Lands ISO Certification

ImaGenes has been granted ISO 9001:2008 certification from the German Society for Certification and Management Systems (DQS) for its genomics and proteomics services, the Berlin-based company said this week.

ImaGenes offers second-generation sequencing services in Germany and Austria based on Illumina's Genome Analyzer II system, and it is a certified service provider for Affymetrix, Agilent, and NimbleGen's microarray technologies.

The certification covers the company's DNA microarray services, bioinformatics analyses, and distribution of validated clone material.

The certification covers the latest standards, and the firm believes it should help lure customers from the pharmaceutical research field in particular, said Johannes Maurer, ImaGenes' director of genomic products and marketing.

CapitalBio Tests Certified for Dx Use in China, Europe

CapitalBio has been cleared by the Chinese government to use its microarray-based diagnostic tests for autoimmune diseases and it has certified with the CE mark tests for tuberculosis testing in Europe, the company said last week.

The Beijing-based diagnostics developer received a certificate from the China State Food and Drug Administration to offer its Antinuclear Antibody Array Test Kits. The certification covers tests for eight different antinuclear antibodies, and it can be used to help diagnose systemic autoimmune diseases including systemic lupus erythematosis, mixed connective tissue disease, Sjögren's syndrome, systemic sclerosis, dermatomyositis, polymyositis, and CREST (calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia) syndrome, said Capital Bio.

The firm also certified three diagnostic tests for tuberculosis with the CE mark.

One of these microarray-based kits can identify 17 mycobacteria species, which can provide information about an infection and help guide treatment, said Capital Bio. The second kit detects drug resistance in the tuberculosis bacteria and also helps doctors decide a correct treatment course. A third test, which is a real-time PCR-based assay, discriminates between tuberculosis mycobacteria and non-tuberculosis mycobacteria, which doctors could use to choose which microarray assay to use.

NIH Offers up to $2M for Genotype Data-Analysis Methods

The National Institutes of Health wants researchers to develop advanced statistical methods that could be used to analyze complex data sets for the influences of genetic variation on tissue-specific gene expression and regulation.

NIH will grant up to $1 million per year over two years to fund two or three research projects that will develop methods that can be used to analyze data sets that are forthcoming from the NIH Roadmap initiative’s Genotype-Tissue Expression (GTEx) Project.

The “Novel statistical methods for human gene expression quantitative trait loci (eQTL) analysis,” program will grant between $200,000 and $300,000 to researchers who will study pre-existing gene expression datasets and, as they become available, data sets from the GTEx program.

All proposed projects must be relevant to eQTL mapping, and those that focus entirely or predominantly on human data, and comparing it to mammalian systems, will have the highest priority, NIH said.

Some examples of the types of studies applicants may seek funds for include those that aim to extend existing methods or develop new methods of integrating and analyzing genotype and gene expression data and regulatory networks; extend or develop new models to make predictions about functional relevance of genetic variants to gene regulation; modifying data reduction tools that can make analysis more efficient; and modeling and exploring the overlap in eQTLs between different tissues.

The funds may also support the development of methods to use multiple datasets or multiple tissue types to reduce the number of false negative results, and the development of creative methods to quantify RNA expression levels from next-generation sequencing data, comparing it to chip-based estimates, and evaluating its impact on the ability to identify eQTLs.

More information on the funding opportunity can be found here.

Beckman Coulter to Pay $17M for Clinical Data's Cogenics Division

Beckman Coulter has inked a definitive agreement to acquire the Cogenics division of Clinical Data for approximately $17 million, Clinical Data said last week.

Cogenics provides genomics services, such as DNA sequencing, gene expression, clinical and non-clinical genotyping, biomanufacturing support, nucleic acid extraction, and biobanking. Its services will complement those of Beckman's Agencourt Biosciences business, which also offers genomics services and nucleic acid purification products.

Under terms of the pact, Beckman will pay Clinical Data $15.4 million at the closing of the deal, which is expected this month. Clinical Data said that it also expects to retain around $2 million in cash from Cogenics immediately prior to the sale. In exchange, Beckman will acquire all of Cogenics' operations in the US, UK, France, and Germany.

Thomas Weisel Partners analyst Peter Lawson estimated in a research note that Cogenics brought in revenues of around $28 million for 2008.

Clinical Data intends to use the funds from the sale to support its late-stage therapeutic programs, including its phase III drug vilazodone for treating depression.

In addition to its drug business, Clinical Data continues to operate its PGx Health division, which is developing pharmacogenetic tests.

UK Plans Livestock, Agriculture Genome Center


The UK's Biotechnology and Biological Sciences Research Council has launched a center that will use genomics to support food security and animal health research.

The Genome Analysis Centre will be housed in the Norwich Research Park and will provide genome sequencing services for programs aimed at improving food security, protecting agriculture from exotic animal disease, and to use weaknesses in microbes to develop new ways to destroy bacteria that are resistant to antibiotics.

TCAG also will serve as a center of excellence in bioinformatics that will handle and analyze genomic data from the livestock and agriculture programs and data from other facilities.

Partners in the new center include BBSRC, East of England Development Agency, Norfolk County Council, South Norfolk Council, Norwich City Council, and the Greater Norwich Development Partnership. BBSRC said that it is providing the majority of the £13.5M ($19.8 million) investment in the center and will "underwrite its running costs for several years, but the partners are all making significant contributions."