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NIH, Panacea Pharmaceuticals, Tandem Labs, PharmaKD, Omicia, BioDiscovery, EBI, Exiqon, Ontario Genomics Institute, Amorfix, Arrayjet, Stratagene, Affymetrix, Strategic Diagnostics, Partners HealthCare,

NIH Picks Lung, Ovarian, and Brain Cancers for Cancer Genome Atlas Project
The National Institutes of Health will map lung, brain, and ovarian cancers for its Cancer Genome Atlas project, the agency said this week [see related interview, this issue].
As part of the pilot phase, the NIH plans to map genomic changes in the cancers.
The agency selected the three cancers because the available biospecimen collections met TCGA’s “scientific, technical, and ethical” requirements, the NIH said.
Boston’s Brigham and Women’s Hospital will supply lung cancer biospecimens from its Lung Cancer Tissue Bank of the Cancer and Leukemia Group B clinical trials group; the glioblastoma biospecimens for brain tumors will come from Houston’s MD Anderson Cancer Center; and the Gynecologic Oncology Group tissue bank at the Children's Hospital of Ohio State University will provide the ovarian cancer biospecimens.

The International Genomics Consortium, part of the Translational Genomics Research Institute, will manage TCGA’s biospecimen core resource, NIH said. The BCR will collect, store, process, and distribute biomolecules from cancerous and normal samples to the Cancer Genome Characterization Centers and Genome Sequencing Centers for genomic analysis. Those centers have not yet been selected.

The National Cancer Institute and the National Human Genome Research Institute launched TCGA in December 2005. The three-year project will use large-scale genome analysis technologies to map genomic changes. The three-year project will use large-scale genome analysis technologies to map genomic changes.

Panacea Launches CLIA Lab, First Test; Others Due in Early ‘07
Panacea Pharmaceuticals this week said it has launched its CLIA-compliant diagnostic testing laboratory, Panacea Laboratories, to provide blood, serum, and tissue tests to diagnose and monitor cancer.
The first test, TK Sense, measures expression of the gene encoding human aspartyl beta-hydroxylase in leukocytes in patients with chronic myelogenous leukemia to identify individuals unlikely to respond to treatment with Gleevec.
Future products will include serum tests to diagnose and monitor prostate, liver, lung, cervical, and other cancers, the first of which should be available in early 2007, the company said.

Tandem Labs Acquires Linden Technologies Unit PharmaKD
Tandem Labs, a Salt Lake City-based bioanalytical and immunoanalytical testing firm, this week said that it has acquired PharmaKD, a subsidiary of Linden Technologies.
Through the acquisition, Tandem gets the rights to PharmaKD’s DMDiscovery drug metabolism technology for increasing the productivity of drug metabolite identification and quantitation, and MarkerScan, a biomarker discovery and screening process for identifying potential biomarkers.
Under the agreement, Tandem Labs will “retain key personnel, intellectual property portfolios, proprietary informatics, scientific instruments, and 7,000 square feet of operational space from PharmaKD,” the company said.
PharmaKD has been renamed Tandem Labs-New England and will offer metabolite profiling, identification, and quantitation; biomarker discovery and screening; protein-binding assays; and discovery bioanalytical support services, Tandem said.
Financial details of the transaction were undisclosed.

Omicia Wins $788K NHGRI Grant to Refine Disease Marker Annotation System
Omicia has been awarded a $788,517 Phase II Small Business Innovation Research grant from the National Human Genome Research Institute to help it refine its disease marker genome-annotation system, the firm said this week.
According to Omicia, the goal of the project is to “facilitate the development of diagnostic profiles for a diverse array of disease conditions.”
Privately held Omicia said that the system uses publicly available genetic variation data to computationally map clinical disease information directly onto the human genome sequence.
The company received a $99,757 Phase I SBIR grant last year to help it develop the system.

BioDiscovery Integrates GeneDirector with EBI's ArrayExpress Repository
BioDiscovery has integrated its GeneDirector data-management system with the European Bioinformatics Institute’s ArrayExpress microarray data repository, the company said this week.
The integration aims at simplifying the task of submitting data to EBI's public repository while preparing for print publication, BioDiscovery said.
GeneDirector manages microarray data, including array and sample tracking, sample processing, hybridization, and image-analysis tracking. According to the company, the system can integrate data from any array technology.

Exiqon Opens Sales and Support Facility in US
Exiqon expanded its US presence by opening a sales, distribution and technical support facility in Boston, the Copenhagen, Denmark-based company said this week.
The facility expands Exiqon's presence and brings support and sales staff closer to the customers, said Michael Kallelis, who is managing the new facility. Exiqon will also offer a microRNA profiling service for researchers that do not want to do the procedure themselves.
The existing Danish facility will focus on sales opportunities in Europe and Asia, where the company is establishing a distributor network.

Ontario Genomics Institute Makes Second Investment in Amorfix to Support Alzheimer's Dx
The Ontario Genomics Institute has made a second investment of Can$50,000 (US$44,687) in Amorfix Life Sciences to support development of a blood test for Alzheimer's disease, Amorfix said this week.
Amofrix issued 47,619 common shares and 23,810 warrants to Genomics Ontario, the investment arm of the institute.
Each warrant entitles the holder to purchase one common share of Amorfix at an exercise price of $1.05 for a term of two years. Both the shares and warrants are subject to a four-month hold period.
Amorfix is developing a blood test for Alzheimer’s disease, EP-AD, based upon its patent-pending Epitope Protection technology.
OGI made its first investment in January.

Arrayjet Sells Microarray Spotters to Two UK Universities
Arrayjet has sold Aj100 Inkjet Microarray Spotters to the UK's University of Exeter and University of Nottingham, the company announced this week
The universities purchased the machines to support the so-called Attogram project, a collaboration between the two schools to that will use "structured light waves constrained on a microscopic surface to visualise how molecules interact with each other," according to the project website.  
The Arrayjet scanners will “form the mainstay microarray capability" of the Attogram project, the company said in a statement.
Financial details of the purchase were not disclosed.
In June, the University of Edinburgh purchased an Arrayjet Aj120 inkjet microarray spotter.

Stratagene Acquires Rights to Predictive Genes for Bladder Cancer from AROS
Stratagene last week said that it has acquired an exclusive licensing option to a family of patents related to bladder cancer owned by Denmark’s AROS Applied Biotechnology.
Under the agreement, Stratagene has the right to evaluate and exclusively license the rights to certain gene groups that have predictive capabilities for bladder cancer.
The agreement expands Stratagene’s molecular diagnostics intellectual property portfolio. The company said it will use the patents to develop Strategene-branded test kits and products.
Financial details were not disclosed.

Affy Hit with Shareholder Suit for Backdating Stock Option Grants
Affymetrix disclosed last week in a filing with the US Securities and Exchange Commission that it has been named in a shareholder derivative suit in the United States District Court for the Northern District of California.
The suit, filed August 30, accuses several current and former officials at Affymetrix of a “gross breach of fiduciary duties” and claims these officials “improperly backdate[d] dozens of grants of Affymetrix stock options” to Affy CEO Stephen Fodor and other executives in violation of generally accepted accounting principles.
The suit, filed by Affymetrix shareholder Irwin Berkowitz, also claims that Affy officials improperly took tax deductions based on the backdated stock options and disseminated “false financial statements and other SEC filings that improperly recorded and accounted for the backdated option grants and concealed the improper backdating of stock options.”
The suit calls for Affy officials to “disgorge to the company all of the backdated stock options they received, including the proceeds of any such options that have been exercised, sold, pledged, or otherwise monetized,” as well as an award of attorneys’ fees and costs.
Affymetrix disclosed in early August that it had uncovered “certain documentation lapses” in its stock-option granting practices and would need to restate its financial results dating back to 1997. It said at the time that an internal review performed under the direction of its board of directors’ audit committee had “not found any pattern or practice of inappropriately identifying grant dates with hindsight.”
On August 30, the company said that it had completed its financial restatement, noting that due to a “documentation lapse” in July 1999, “an option grant for an aggregate of 1.99 million shares should have been measured for accounting purposes as of a later date.” The restatement included corrections relating to certain other errors and documentation lapses in the fiscal years 1997 and 1998, Affymetrix said.
Affymetrix said in last week’s SEC filing that it “expects to contest vigorously the backdating allegations in the complaint.”
The company added that it may be subject to other lawsuits from private plaintiffs concerning this subject area, and that it does not expect to disclose any additional lawsuits that are based on similar allegations.
A company spokesman declined to comment further on the suit.

Strategic Diagnostics to Supply Reagents to Undisclosed IVD Manufacturer
Strategic Diagnostics said last week that it has signed an agreement to supply reagents to “a large manufacturer of in vitro diagnostics.”
The term of the agreement is five years, and the company said that it expects initial revenues of around $1 million per year, which are anticipated to “more than double” over the term of the agreement.
Strategic Diagnostics said it will begin shipping the reagents to the undisclosed client in the fourth quarter.

Affy and Partners HealthCare to Develop CLIA-Validated Genetic Tests
Partners HealthCare and Affymetrix have signed a three-year translational research collaboration to develop microarray-based diagnostics tests, the two organizations said last week.
Under the collaboration, Partners HealthCare’s researchers at Harvard Medical School, Partners HealthCare, and Harvard Medical School-Partners HealthCare Center for Genetics and Genomics will create and validate microarray tests using Affymetrix GeneChip genotyping, resequencing and expression technologies in Clinical Laboratory Improvement Amendments laboratories.
Affymetrix and HPCGG estimate that it may take a year to develop the first chip-based diagnostic test for use in the CLIA-approved lab. The CLIA-validated tests will first be offered to patients in the Partners HealthCare system.
Financial details were not disclosed.

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