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Clinical Data Inks PGx Deal with U of Pittsburgh


Clinical Data has entered into a collaboration with the University of Pittsburgh to discover and validate Fc gamma receptor gene markers that may eventually lead to the development of new pharmacogenetic tests that gauge response to monoclonal antibodies, such as Herceptin, Rituxan, and Erbitux.

The research partnership, announced last month, will expand Clinical Data's existing FCGR program under its PGx Health division, which includes the PGxPredict: Rituximab test and research collaborations with other institutions.

"Our goal is to validate the biomarkers or genetic variants associated with response and potentially discover other genetic variants in this gene and their impact on response to IgG1 mAb-based therapies," according to a Clinical Data spokesperson. The company aims "to utilize this information in developing tests to predict drug response, as we have done with our PGxPredict: Rituximab test."

The announcement is in line with the company's previously outlined 2009 strategic goals, which include driving adoption of its Familion and PGxPredict brand of assays in the cardiovascular disease market, and establishing research collaborations to discover and validate genetic variants in the FCGR pathway that predict response for monoclonal antibodies.

Under the research collaboration between the University of Pittsburgh and Clinical Data, the partners are planning to conduct a series of clinical trials to gauge the link between FCGR gene variants and response to mAb-based therapies, such as Erbitux (cetuximab), Rituxan (rituximab), Herceptin (trastuzumab), and potentially other mAb cancer drugs in the IgG1 subclass.

The initial research program between PGxHealth and the university will focus on gauging responsiveness to Erbitux in head and neck cancer patients. Robert Ferris, associate professor and chief of the head and neck surgery division at the University of Pittsburgh Cancer Institute, will lead the study.

— Turna Ray


$1 million

NCI and the Canary Foundation have teamed up to offer $1 million grants to studies of genetics and diagnostics for lung cancer.

PGx & Molecular Dx Notes

The US Centers for Medicare & Medicaid Services found insufficient evidence to demonstrate the effectiveness of pharmacogenomics-guided warfarin dosing in improving health outcomes and deemed the use of pharmacogenomic testing for this to be unnecessary.

Ipsogen, a French molecular diagnostics company, licensed non-exclusive rights to use gene variants for diagnosing leukemia to the University of Utah's ARUP Laboratories.

Becton Dickinson and Fujirebio Diagnostics signed a worldwide development and supply agreement for multiplex oncology diagnostic assays. The companies will develop diagnostic products that contain Fujirebio's biomarkers that will run on BD's multiplex testing platform.

Funded grants

$66,400/FY 2009
Hereditary Breast Cancer and Novel Hispanic BRCA Mutations
Grantee: Jeffrey Weitzel, City of Hope
Began: Mar. 1, 2009; Ends: Feb. 28, 2011

Weitzel and his colleagues will use the funds to study a panel of BRCA mutations previously linked to women of Hispanic ancestry to pre-screen samples to determine whether this ancestry demonstrates clinical utility. The team will collect DNA samples and clinical data from Hispanic patients and then "use ancestral informative markers to characterize the admixture of carriers."

$146,568/FY 2009
Micromagnetic Aptamer PCR System for Ultrasensitive Multiplexed Protein Detection
Grantee: Hyongsok Tom Soh, University of Califonia, Santa Barbara
Began: May 1, 2009; Ends: Apr. 30, 2011

Soh proposes to develop a "Micro-Magnetic Separation — Quantitative Polymerase Chain Reaction" system integrating chip-based micro-magnetic separation with aptamer-based quantitative PCR to help alleviate the problem of detecting and quantifying protein biomarkers of low abundance in clinical samples.

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