February 2009 Clinical Laboratory News: Industry Profiles

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February 2009: Volume 35, Number 2

Clinical Data to Investigate Role of FCGR3 in Cancer Treatment

Clinical Data, Inc. announced that it has established a research collaboration with Antonio Musolino, MD, of the University Hospital of Parma, Italy, to study the use of genetic variants in the Fc gamma receptor pathways (FCGR3), with the ultimate goal of predicting the response to trastuzumab (Herceptin) therapy in patients with breast cancer. The signaling pathway encoded by the FCGR3A gene is important in regulating antibody-dependent cellular cytotoxicity, a mechanism that affects the efficacy of many monoclonal antibody-based therapies. Clinical Data and Musolino will analyze certain genetic variants in an international trial of approximately 300 breast cancer patients receiving trastuzumab and other drugs in a neoadjuvant setting. The study is expected to be completed by the end of 2009.

National Jewish Health, LabCorp to Collaborate on Pharmacogenomics

National Jewish Health and LabCorp have reached an agreement to collaborate on the development and commercialization of molecular diagnostic tests for personalized medicine applications. The collaboration joins National Jewish Health’s expertise in molecular diagnostics and respiratory, immune, and related diseases, and LabCorp’s strengths in personalized medicine and esoteric testing. Gary Smith, PhD, executive director of the Advanced Diagnostics Laboratory at National Jewish Health, stated, “This important collaboration with LabCorp will allow us to provide specialized companion diagnostic tools to a much broader audience.” Financial terms of the agreement were not disclosed.


Roche, Southern Medical Agree on Applications of Surfactant Protein-B

Roche Diagnostics has signed a licensing agreement with Southern Medical Diagnostics (SMD) which provides Roche with semi-exclusive worldwide rights for diagnostic applications of surfactant protein-B (SP-B) in lung disorders and gives SMD worldwide rights to key test components developed by Roche. SP-B is a lung-specific protein that is released into the blood as a result of injury to the lungs. A change in the concentration of SP-B can be indicative of a variety of disorders, including COPD, acute respiratory distress syndrome, and heart failure. 

NCI Awards $1.15 Million to Rules-Based Medicine

NCI has awarded a $1.15 million Small Business Innovation Research contract to Rules-Based Medicine (RBM) for research on ovarian cancer diagnostics. The grant allows the development and testing of immunoassays incorporating 19 additional analytes that have been identified by RBM and Correlogic Systems as potential candidates for detecting ovarian cancer. The peer-reviewed contract to develop biomarker panels includes a Phase I “fast track” component and a Phase II option. RBM and Correlogic collaborated on the production of OvaCheck, Correlogic’s first ovarian cancer diagnostic. 

    Affymetrix Technology Powers Cincinnati Children’s Hospital’s Test for Jaundice

Cincinnati Children’s Hospital has used technology developed by Affymetrix to develop a molecular diagnostic test designed to diagnose genetic defects in patients with an inheritable form of jaundice. The custom microarray, also known as the Jaundice Chip, is effective in detecting the five most common genetic mutations responsible for inherited forms of jaundice, representing about half of all chronic pediatric liver disease cases. Cincinnati Children’s intends to expand the Jaundice Chip to identify more precisely patients at risk for progressive liver disease and has already made the test available to clinicians around the world. 

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