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Genaissance Allowed Patent for Method of Testing Individuals for Genetic Predisposition to Reduced Metabolism of Drugs

15 Mar 2005 - Genaissance Pharmaceuticals, Inc. has received a notice of allowance from the U.S. Patent and Trademark Office. The allowed patent, which is co-owned with Duke University, claims testing for a common genetic variant in the CYP3A4 gene to predict whether or not an individual is a poor metabolizer of certain drugs. It is estimated at least 50 percent of all drugs, including chemotherapeutic agents and a wide variety of over-the-counter medications, are metabolized by the CYP3A4 enzyme. Individuals with a reduced ability to metabolize these drugs may be exposed to higher levels of the drug, placing them at risk for adverse drug reactions.
 
The allowed patent, "Methods for Evaluating the Ability to Metabolize Pharmaceuticals," describes the selection of chemotherapeutic agents based on the presence or absence of this variant, which is commonly called CYP3A4*1B. The patent also describes how a mutation in the GSTM1 gene affects drug metabolism.
 
In addition to the pharmacogenetic uses described above, the CYP3A4*1B variant may also be useful in identifying individuals at risk for prostate and breast cancer. An earlier related patent describes the discovery of the CYP3A4*1B variant and its detection.
 
Kevin Rakin, President and Chief Executive Officer of Genaissance, indicated the company's CYP3A4*1B assay technology may ultimately be incorporated in a simple DNA test that would provide potentially valuable prescribing information to physicians. "The clinical utility would be to appropriately dose medications that could cause harm if not fully metabolized, especially in the elderly or in cases where patients are receiving multiple drugs," he added.