Personalized medicine comes of age in AssureRx Health test

“The age of personalized medicine is upon us,” said Jim Burns, chief executive of AssureRx […]

“The age of personalized medicine is upon us,” said Jim Burns, chief executive of AssureRx Health Inc., the Cincinnati-area, company that has developed a genetic testing system to help doctors pick the right psychiatric drugs for patients.

And in no other field is the need for personalized medicine so great. One in four of us will need help in our lifetimes to fight illnesses from depression to schizophrenia, or disorders like obsessive-compulsive. Now, many patients try a dozen drugs to find one that works — and doesn’t cause bigger problems.

GeneSightRx — the first test developed by AssureRx and launched in October — uses a cheek swab, mathematical algorithms and bioinformatics to narrow drug choices to those that work with a patient’s genes. The Mason, Ohio, company provides its online pharmacogenetics report to doctors within 36 hours of receiving a sample at its CLIA-certified laboratory, Burns said.

“Pharmacogenetics is going to be one of two technologies that’s going to transform the practice of psychiatric medicine,” he said.

A promise for more than a decade, the practice of using targeted diagnostics and therapeutics based on a patient’s genes “is fast emerging as the current state in diagnostics and therapeutics,” according to a 2009 report (pdf) by Deloitte Center for Health Solutions. “Innovations based on genetic and molecular designs offer patients better care at lower cost because conditions are predicted sooner, diagnosed more accurately and treated more effectively.”

Personalized medicine is a disruptive innovation that will require new business models, said global business consultant PricewaterhouseCoopers (PWC) in its The New Science of Personalized Medicine report. PWC projects the worldwide pharmaceutical, medical device and diagnostics segment of the market to be worth $24 billion and growing at 10 percent a year.

AssureRx is part of the emerging diagnostics market. “This is an application of genomic medicine that is going to make a big difference,” said Dr. Brian Duncan, a former pediatric heart surgeon who now is a venture capital partner for Arboretum Ventures in Ann Arbor, Mich. and a business developer for BioEnterprise.

“It is a truly exciting technology,” Duncan said. “It is a fantastic combination of the science that comes from genomics and the science that comes from bioinformatics to create a relevant clinical decision support tool.”

Founded in 2006 to commercialize from research at Mayo Clinic in Rochester, Minn. and Cincinnati Children’s Hospital Medical Center, AssureRx initially is targeting neuro-psychiatric and neuro-behavioral disorders because they represent the largest unmet patient need.

“Antidepressants and antipsychotics are the single-largest category of drug prescriptions in the U.S.,” Burns said. “Yet the prescribing has been trial-and-error because there haven’t been any evidence-based tools available to the psychiatrist to figure out which drugs are going to work for which patients.”

Because the AssureRx test is positioned to help a large patient segment, it also has a large market opportunity. Burns sees an annual U.S. market of about $3 billion per year “on the low end. It’s a potentially transformative kind of technology,” he said. “And I think we’re off to a good start because we have a major partner to help us launch.”

In 2008, AssureRx struck a developmental partnership with Diamond Healthcare Corp. in Richmond, Va., “the largest private manager of behavioral health programs in the U.S.,” he said. Diamond Healthcare is beginning to use GeneSightRx (pdf) to choose drugs for patients at its facilities.

The pharmacogenetic test already has become the standard of care for Cincinnati Children’s Hospital, one of its developers, Burns said. “In the next year or two, we will see clinical practice guidelines being changed as a result of this technology being available. That’s how fast the whole thing is progressing.”

AssureRx added a fifth gene to its test in March. The company is trying to raise between $8 million and $10 million in institutional money for its second financing round, Burns said. Since 2006, AssureRx has raised about $5 million from investors including Queen City Angels, CincyTech, the Health Foundation of Greater Cincinnati, Blue Chip Venture, Cincinnati Children’s Tomorrow Fund and individual investors, he said.

This time, the company would use its investor money “for clinical development, market development and further product development to expand the market base and build future products,” Burns said. Future products might include tests that help doctors choose medications for patients who have neuro-degenerative diseases like Alzheimer’s or Parkinson’s, as well as disorders such as attention-deficit hyperactivity and post-traumatic stress.

AssureRx also is adding jobs. “We have 11 employees right now,” Burns said. “We’ll be growing to about 30 — nearly tripling — within the next 12 months.”

Though GeneSightRx has been used commercially to help patients “in the 100s,” Burns said, it was used by Mayo Clinic on about 5,000 patients and by Cincinnati Children’s on about 7,000 patients, during testing.

Personalized medicine may be just getting started, but it’s here to stay. “This is a new era,” Burns said. “Ten-to-15 years from now, we will just take it for granted.”

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