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Gentris hopes technology will herald the age of personalized medicine

The answer to this crucial metabolic question and others is the charge of Gentris Corp. of Research Triangle Park, a pharmacogenomics company seeking to help the pharmaceutical industry and physicians develop and prescribe drugs around human metabolic idiosyncrasies.

The recent mapping of the human genome paved the way for Gentris' work; the 100,000 or so deaths each year resulting from the adverse effects of prescription medications are the catalyst.

According to a 1998 study published in the Journal of the American Medical Association, this is one of the top five causes of death -- on par with heart disease and cancer -- and has been that way for more than 30 years.

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Despite stringent clinical trial requirements and federal oversight in the U.S., it was impossible until recently to know the kind of reaction that a specific patient would have to a specific drug.

"It is largely an exercise in trial and error," said Michael Murphy, M.Sc., Gentris' president and CEO. The only distinction that a prescribing physician makes is between a child and an adult, he added.

But the new field of pharmacogenomics allows scientists to study the human genes responsible for drug metabolism and note their mutations among individual patients. This capability has allowed Gentris to begin its development and launch of a series of diagnostic services and products around a group of eight metabolic enzymes in the liver.

A select group of these enzymes determine the rate of a patient's metabolism. A poor metabolizer, for instance, would do well to limit the use of codeine, which is often prescribed for mild to moderate acute pain; a rapid metabolizer would need an increased dose in order to benefit from the pain killer.

L. Scott Clark, Ph.D., the company's director of laboratory services, brought his own DNA profile up on a computer screen recently to demonstrate his metabolic idiosyncrasies. Clark is a poor metabolizer.

"We don't let him have cough medicine because he will be wired for days," Murphy said.

At a doctor's visit recently, Clark presented the staff there with a list of drugs that wouldn't work based on his metabolic profile. "They didn't listen to me that time and there were some mild adverse reactions," Clark said. "The second time I went in, they paid attention to the list."

Gentris currently provides Good Laboratory Practice (GLP)-compliant testing services that capture 99 percent of all the mutations that predict patient outcome. The company also provides testing for ethnic variations among the population, and can determine how individual patients will respond to anti-thrombolytics, anti-inflammatory compounds, pain-relievers and psychotropic compounds.

These testing services are currently used in the drug development process to improve trial design and predictability, which the company said will help shorten the drug development cycle, improve new drug approval rates and market positioning, and enable companies to retest drug candidates that fail to meet clinical trial or FDA approval standards. Murphy is advising the FDA on the development of new metabolic profiling requirements for previously approved prescription drugs.

The pharmacogenomics field is relatively new and there are just a few companies working to meet the challenge. Murphy was lured into the field in the 90s -- when it was known as pharmacogenetics. He was the cofounder of the former Intek Labs, the first international pharmacogenomics company.

Murphy collaborated in 1998 with William E. Evans, Pharm.D., from St. Jude Children's Research Hospital (SJCRH) in Memphis, Tenn., to commercialize the first pharmacogenomics test now used routinely to determine drugs and doses for the treatment of childhood leukemia. Intek Labs was acquired by PPD of Wilmington and then became PPGx under the PPD banner in 2000. PPGx was eventually sold to DNA Sciences of Fremont, Calif.

Murphy and co-founders launched Gentris in 2001 with $1.5 million in venture and angel funding. Since that time Gentris has developed 19 drug metabolism tests and automated the genotyping process in collaboration with technology and diagnostic companies including Nanogen of San Diego, Calif., and Promega of Madison, Wis. Gentris is seeking $10 million in Series B financing for future development.

Gentris currently focuses on clinical trial drug development testing services. In 2003, the company plans to roll out pharmacogenomic kits that will help standardize testing in the diagnostics industry. There are currently no standardized control components for these tests, so laboratories typically have to develop internal "home brew" controls that may be slightly different from the controls used by other diagnostic laboratories providing the same test.

In the near future, Gentris will develop specialized, high quality, reliable diagnostic tests that will provide pharmacogenomic testing directly to physicians and their patients.

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Gentris hopes technology will herald the age of personalized medicine

BT Catalyst, Sept, 2002

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