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Agendia, Agilent Technologies, Gene Express, University of South Florida, Theranostics Health, NIH, Life Sciences Discovery Fund, Pacific Northwest National Laboratory, University of Washington, Clinical and Laboratory Standards Institute, DOD, DOE, Pacif

Agendia, Agilent to Develop Dx Tests, Extend Supply Pact
Agendia and Agilent Technologies announced this week that they have extended a supply agreement and intend to collaborate on the development of new in vitro diagnostic tests.
According to a joint statement, the firms will collaborate on developing cancer diagnostic tests that will be run on Agilent microarrays.
In February 2007, Amsterdam, Netherlands-based Agendia received US Food and Drug Administration clearance for its MammaPrint diagnostic for breast cancer recurrence. The test, which is performed on an Agilent microarray, was the first in vitro diagnostic multivariate index assay device approved by the FDA since the agency released a draft guidance in 2006 describing such products.
The partners also announced that Agendia’s products will continue to be supplied on Agilent microarrays through Dec. 31, 2011. Agilent has been manufacturing the components for the Agendia assay since 2003, the firms said.
"We eagerly anticipate expanding our role beyond the manufacturing of Agendia products on the Agilent microarrays to helping them build validated diagnostic cancer tests, as well as developing and expanding the company's worldwide distribution channels,” Yvonne Linney, vice president and general manager of genomics for Santa Clara, Calif.-based Agilent, said in the statement.
Financial terms of the agreements were not disclosed.

Gene Express Licenses USF IP for Lung Cancer Predictive Test
Gene Express said this week that it has licensed technology from the University of South Florida that it will use to develop a prognostic test to be used in the treatment of lung cancer.
The company licensed gene expression technology related to the ERCC1 and RRM1 genes from USF’s Division of Patents & Licensing Research Office.
USF researchers have found that ERCC1 activity can be used to predict survival in patients with non-small cell lung cancer and have found that RRM1 is a determinant of malignant behavior in NSCLC.
Gene Express said USF’s scientists have determined that knowing the level of expression of RRM1 allows for better-informed decisions than currently used predictors of tumor stage, performance status, and weight loss.
The Toledo, Ohio-based company said it plans to develop the prognostic test and commercialize it over the next two years.
Gene Express expects to complete clinical validation to correlate gene expression with chemoresistance for cisplatin treatment and to submit a 510(k) class II prognostic test to the US Food and Drug Administration by May 2009. The firm hopes to obtain approval from the FDA by August 2009 and have the test on the market by the end of next year.

Theranostics Licenses Biomarker Microdissection Tech from NIH
Theranostics Health said this week it has licensed proteomic biomarker discovery technology from the National Institutes of Health that was developed by the company’s founders.
The Rockville, Md.-based company’s core technology, Reverse Phase Protein Microarray combined with Laser Capture Microdissection, was developed by company co-founders Emanuel Petricoin and Lance Liotta.
Under the agreement, Theranostics will pay NIH license issue royalties, minimum annual royalties, and benchmark and earned royalties upon successful commercialization of the technology.
Petricoin, CSO of Theranostics, said in a statement that the company's “unique signaling pathway platform allows the activity of theranostic biomarkers of interest to be quantitatively measured from microdissected patient samples.”
Theranostics Health CEO Danong Chen said the exclusive license allows the company to develop companion diagnostics to be used in treatment decision-making and monitoring.

Washington State Funnels $10M into Two Genomics Programs
A Washington State investment fund has awarded just over $10 million to support genomics research projects in the state as part of a $22 million biology-focused initiative.
Under the Life Sciences Discovery Fund’s new program, the Pacific Northwest National Laboratory was awarded $4.8 million for biomarker research and $5.3 million to build a new genomics infrastructure at the University of Washington. Three other non-genomic, life science research programs received the rest of the funds.
The LSDF chose this first group of five total grantees from 75 proposals that had been evaluated by the American Association for the Advancement of Science. The money comes from Washington State’s portion of bonus payments from the Master Tobacco settlement that came from multi-state litigation with tobacco companies.
Richard Smith of PNNL will use $4.8 million to fund next-generation clinical proteomics research to be conducted with the University of Washington. Smith aims to develop new proteomics technology that could be used to hunt for blood biomarkers for liver disease and to study cancer, diabetes, and other conditions.
The researchers hope to find a safer, non-invasive diagnostic for liver fibrosis than biopsy.
According to LSDF, the research also will focus on extending the technology platform to address problems in other diseases and to make it commercially available for broad commercial use.
The University of Washington’s Gail Jarvik will use $5.3 million to build a new infrastructure that will enable high-volume analysis of genomic data in medical genetics.
The goal is to optimize these resources for translational research focused on developing gene-based diagnostics, prevention strategies, and treatments, LSDF said. The UW researchers expect over the long term to identify a large number of disease-related biomarkers that could potentially be used to develop new diagnostic and therapeutic agents.

Nonprofit Group Offers Guidelines for Multiplex Assays
Citing the rapid recent growth in the number of multiplex assays making their way to market, a nonprofit medical testing group with industry ties has drawn up a set of recommendations for lab practices and controls.
The Clinical and Laboratory Standards Institute’s recommendation, “Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline," offers guidelines for analytic verification and validation of multiplex assays and a review of biologic and synthetic reference materials.
The recommendations cover sample preparation; reference quality control materials; analytic verification and validation; data analysis; and reporting results. It also offers a discussion of multiplex methods and technologies.
The goal of the guide, which costs $120 for non-CLSI members and $60 for members, is to help labs and manufacturers in the development, verification, validation, and implementation of multiplex nucleic acid tests for diagnostic purposes.
“Almost all of the new clinical tests are based on multiplexing of analytes, and there is currently no other reference available for this purpose,” Jean Amos Wilson, a CLSI committee co-chair and senior director of Sequenom’s Genetic Services Lab, said in a statement.
The paper also contains an overview of current technologies, as well as a review of the designs and uses of control materials such as blood samples, residual patient samples, products of whole genome amplification, synthetic oligonucleotide simplex and multiplex controls, and plasmids. The authors also illustrate proper verification and validation protocols using current assay formats and appropriate data analysis and results reporting.
The report is available here.

DOD Spending $2M for Breast Cancer Biomarker Study Using Army Samples
The US Department of Defense is putting $2 million into a two-year collaboration between three research institutes that will focus on finding proteomic biomarkers that could be used to detect aggressive breast cancer.
The Department of Energy’s Environmental Molecular Sciences Laboratory at the Pacific Northwest National Laboratory in Richland, Wash., will conduct proteomics research using mass spectrometers on samples provided by researchers from the Walter Reed-Windber Clinical Breast Care Project, PNNL said last week.
The Army’s active duty ranks are around one-fifth women, and the Army also is responsible for healthcare for the wives of their married male soldiers. The Windber Institute, through the Army’s Clinical Breast Care Project, has access to 30,000 breast cancer and blood samples from around 4,000 female patients.
"We're looking for aggressive cancer indicators in pre-menopausal women, and the Army has both the tissue samples and the matching plasma," said Karin Rodland, a cancer biologist at PNNL.
The researchers at PNNL plan to compare the proteins from cancers that remained in the breast to those that spread to lymph nodes in an effort to reveal which proteins metastasizing tumors use to move through the body. The researchers expect that finding these potential biomarkers would help differentiate the proteins that affect younger women.
After some of these proteins are identified as possible biomarkers, the researchers will search blood samples to find which proteins occur there as well as in the tumor tissues. After two years of research, the scientists “expect to have a handful of biomarkers that can then be tested in women newly diagnosed with breast cancer,” PNNL said.

Indiana University Lab Joins NIH's Global PGx Alliance
Researchers at Indiana University’s School of Medicine will join in a new National Institutes of Health initiative that aims to advance pharmacogenomics research, particularly in cancer, IU said last week.
The NIH earlier this week announced that it had created the Global Alliance for Pharmacogenomics with Japan’s Center for Genomic Medicine that will forge a global effort to identify genetic factors behind individual responses to disease treatments.
The IU end of the research will be led by David Flockhart, a scientist at IU’s Melvin and Bren Simon Cancer Center and chief of the division of pharmacology at the IU School of Medicine. Flockhart will focus on the role of genetic factors in the effectiveness of certain breast cancer drugs that can help block the growth of tumors by lowering estrogen levels.
The university said Flockhart is already researching individual genetic reactions to breast cancer drugs through a five-year project, which has received $12 million in NIH backing. 
Flockhart’s lab previously performed work showing that some women do not respond well to the breast cancer drug tamoxifen because of a genetic variation that affects how they metabolize the drug, IU said.

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