Metabolon and the Harvard-Partners Center for Genetics and Genomics Announce Warfarin Dosing Diagnostic Development Collaboration

Metabolon, Inc., the leader in metabolomics-driven biomarker discovery and analysis, and the Harvard-Partners Center for Genetics and Genomics (HPCGG), a collaborative program dedicated to promoting genetics and genomics in research and clinical medicine, announced today that they have signed an agreement to develop an improved diagnostic test for enabling a more accurate dosing of warfarin.Warfarin, a blood thinning agent prescribed extensively during the last 50 years, causes more than 700,000 adverse events per year due to improper dosing (JAMA 2006; 296).

There are several academic and commercial efforts currently underway, including the Partners CROWN trial (described below), aimed at examining the effectiveness of stratifying patients for warfarin dosing based on a patient's genetics. Now, in addition to studying the impact of genetics on warfarin dosing, HPCGG seeks to also examine whether a patient's metabolomic profile might also increase the likelihood of dosing warfarin correctly.

Dr. Raju Kucherlapati, director at HPCGG commented, "If we can improve the accuracy of warfarin dosing by our clinicians, even by modest percentages, we will increase the likelihood that patients will respond to therapy and ultimately we will reduce serious medical complications of therapy. Metabolon's biomarker discovery platform gives us the opportunity to find biochemical markers that along with genetic variations might help characterize the differences between patients' metabolism of warfarin."

Patient samples for the study are being collected as part of the ongoing Partners HealthCare "CReating an Optimal Warfarin Nomogram" (CROWN) trial, which is a prospective dosing study utilizing genetic testing to determine the optimal warfarin dose and how this information can be used for clinical care. Sample collection for the diagnostic development should be complete early summer 2008, with the metabolomic analysis being conducted by Metabolon thereafter. Upon completion of the study, both HPCGG and Metabolon expect to report results from the collaboration in a peer-reviewed publication.

Also announced today, Partners HealthCare investigators have received preferred access to Metabolon's global biochemical profiling platform. Metabolon currently provides these services to the top pharmaceutical and biotechnology companies as well as other agriculture, consumer product and bioprocessing organizations. These services provide for the extraction, identification and quantitation of hundreds of small molecule biochemicals in a given biological sample. Significantly altered metabolites are then highlighted in extensive biochemical interpretation provided by Metabolon scientists.

"We are very excited about initiating a long-term relationship with the Partners HealthCare research teams," said Dr. John Ryals, president and CEO of Metabolon. "Our work on the warfarin diagnostic coupled with the broad access to our discovery platform now available to the Partners HealthCare investigators, will firmly establish Metabolon's impact on the development and delivery of diagnostics to critical areas within patient care."