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September 1, 2010
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A Dose of Success

Louisville life science lab gains traction with product to predict patients’ drug-therapy outcomes

By Mariam Williams

Nancy Johnson, senior medical technologist, pipettes samples for testing at PGxl Laboratories, a pharmacogenetics testing lab in Louisville.

To say that PGxl Laboratories is doing well is an understatement. The Louisville biotechnology company’s revenues have grown 35 percent annually for the past four years, and it recently joined a new venture that could dwarf that statistic easily, according to Roland Valdes Jr., PhD, the company’s president and co-founder.

In March, PGxl inked an agreement with genetics-benefits management company Generation Health Inc. to become a select provider in CVS Caremark Corp.’s Best Test Genetics Network, a PPO specifically for pharmacogenetic intervention and testing. CVS launched the program in July. Generation Health oversees the selection of providers.

The agreement helps PGxl fulfill its mission of helping clinicians and patients make informed choices about drug therapies. And it provides an encouraging demonstration of what’s possible for high-tech companies in the commonwealth.

PGxl is a pharmacogenetics testing lab that tests DNA samples to determine how an individual’s genetic makeup will influence his or her response to medication. The testing helps clinicians adjust dosages, decrease the risks of side effects and eliminate possibly years of trial and error by telling them up front what a patient’s response to a drug is likely to be based on that patient’s genetic characteristics, said Mark Linder, PhD, PGxl co-founder and senior vice president of company operations.

CVS Caremark, the largest pharmacy in the United States, created Best Test Genetics Network to educate physicians about the advantages of pharmacogenetic testing and make that testing more affordable for its 55 million customers. PGxl joins Clairent and a major lab soon to be announced as the three labs chosen to be the first members of the new PPO.

Jeffrey Marrazzo, vice president of sales and business development at Generation Health, said the company tapped PGxl for its renowned expertise.

“We knew they had experience in building and operating a lab and were thought leaders in pharmacogenetic testing. When we think longer term about the relationship, that is of great value to us,” said Marrazzo.

UofL research commercialized

Valdes and Linder are professors in the Department of Pathology & Laboratory Medicine at the University of Louisville. Valdes also is a distinguished university scholar and senior vice-chairman. Linder was a post-doctoral fellow in the university’s Clinical Chemistry & Toxicology program, where he trained under Valdes to become a laboratory director.

Valdes said he recognized clinical chemistry’s probable evolvement into pharmacogenetics in the mid-1990s. He and Linder received wide recognition in their field then for articles published in the journal Clinical Chemistry on how to translate pharmacogenetics into clinical practice.
Most recently, the two co-edited the National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines, 2010 edition.

PGxl is an example of how university and state support can help take a high-tech company from academia to the commercial realm.

In 2004, Valdes and Linder founded PGxl as a research laboratory on the University of Louisville campus. There, they invented PerMIT:Warfarin, Web-based software that allows physicians to calculate optimum doses of the blood-clot-prevention drug warfarin through pharmacogenetic test results. Upon becoming an independent company in 2005, PGxl optioned the technology from the university.

Becoming a private company “opened an enormous number of doors and possibilities,” said Valdes.

The move enabled PGxl to form strategic partnerships with other clinical labs to develop products jointly, hire staff more quickly and apply for grants available only to small, for-profit high-tech companies.

The warfarin technology optioned from University of Louisville “formed the basis for some federal SBIR funding we’ve been able to compete for, and the state of Kentucky has matched a large portion of those federal funds,” said Linder.

Federal Small Business Innovation Research (SBIR) and Small Business Technology Transfer (SBTT)?grants “encourage small businesses to explore technological potential and maximize profit from commercialization,” said Deborah Clayton, commissioner of the Department of Commercialization and Innovation. The NIH and NASA are among 11 federal agencies distributing $2 to $3 billion in grants annually, $34 million of which has gone to Kentucky companies since 2006.

The state’s Phase 1 SBIR and STTR program matches up to $150,000 in federal funds for concepts. Phase 2 matches up to $500,000 annually for research and development. Since the matching program began in October 2006, the state has awarded a total of $20.5 million in 92 awards to 57 high-tech companies.

Clayton said the program has brought nine high-tech firms to the state from other parts of the country. Kentucky is the only state that matches Phase 2 federal funds, and that amount of capital at that stage, Clayton explained, is critical for high-tech companies to develop the expensive technology and attract the private investment needed to hasten commercialization.
PGxl has received more than $1.5 million in federal SBIR grants and $975,000 in state matching grants since 2006.

Valdes and Linder see PGxl as being at the foundation of a trend toward proactive, preventative medicine and health care integration.

Acquiring the highly competitive contract with Generation Health “speaks a lot to the environment, the support we’re getting from the city, from the state and from the university,” he said.

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