Taking guesswork out of neurotropic drug selection

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Mayo Clinic’s genotype testing offered by Assurex Health guides selection of mental health drugs for individual patients

Treating mental health disorders often involves repeated adjusting and piggybacking of a patient’s psychotropic medications in order to find the best treatment option.

Antipsychotic drugs are used in standard treatment for schizophrenia and antidepressant drugs as the standard of care for depressive disorder. But nearly half of psychiatric patients don’t respond well to treatment using standard drug therapy.

Consequently, prescribing medications for mental health treatment is often guesswork and an empirical cycle of trial and error. But thanks to technology invented at Mayo Clinic, GeneSight Psychotropic, a groundbreaking product from Assurex Health, Inc., is taking the guesswork out of prescribing drug therapies. GeneSight, a multimarker molecular diagnostic tool, analyzes mental health patients’ genetic markers to evaluate what drugs would likely provide better outcomes and thus helps physicians make treatment decisions for patients with mental health conditions such as depression, post-traumatic stress disorder and schizophrenia. Clinicians’ genetically guided treatment decisions for depressed and schizophrenic patients help improve their outcomes. In 2006, the technology was exclusively licensed to Assurex Health through Mayo Clinic Ventures.

GeneSight analyzes 50 alleles — alternative forms of the same genetic locus — from six genes to determine a patient’s response to antidepressant and antipsychotic treatments using more than 30 drugs.

Historically, doctors have not been able to pinpoint which patients will be vulnerable to adverse reactions or are likely to respond negatively or positively to specific psychotropic drugs. Predicting such outcomes is a lofty goal and a credible one, attainable if a high-performance, reliable genetics screening tool is available.

When doctors have genetic markers for how their patients are likely to react, it can make all the difference in the success of the treatment, especially if a treatment otherwise would put patients at risk for side effects or possibly an emergency situation.

How Mayo Clinic moved psychotropic gene testing forward

In 2002, Mayo Clinic researchers had a big idea that involved using genetic identification tools to predict a patient’s likely response to mental health treatments. Inventors responded to the question of whether genetics could predict how a patient could react to specific medications based on how their body was built to react.

With that idea, the pursuit began to develop technology for personalizing drug therapy in choosing the best medication and dosage for treating mental health patients.

Mayo Clinic’s venture capital investment advanced the research and supported the efforts of inventors David Mrazek, M.D., John Logan Black III, M.D., and Dennis O’Kane, Ph.D. The clinical team developed the initial algorithm used in the genetic test that guides physicians when prescribing medications.

The technology’s inventors selected five genes and drug targets — serotonin transporters and serotonin receptors 2A, 2C to build the algorithm of the core technology.

The trailblazing work was a much-needed solution in advancing effective use of psychotropic drugs.

The importance of funding and interacting with industry

Mayo Clinic’s investment in the research that led to personalized genetic testing is an excellent example of how believing in and investing in technology can make a great deal of difference in many people’s lives. Without such funding, the technology behind GeneSight might not have found its way to market.

“The only way to do this is to work with industry,” says Black, co-director of the Personalized Genomics Laboratory and vice chair for Business Development at Mayo Clinic. He was the co-developer of the core technology that was licensed to Assurex.

Commenting on the value of GeneSight’s guidance, Black says, “It’s hard to know how a patient may react to psychotropic drugs, especially when they can’t tell you, which is often the case in very young or elderly patients.”

Number of benefited patients doubles annually

GeneSight technology analyzes patients’ genes and provides psychotropic results for using antidepressants and antipsychotics for the patient. The color-coded written guidelines for use with various commonly prescribed drugs are categorized in green for “use as directed,” in yellow for “use with caution” and in red for “use with increased caution and with more frequent monitoring.” Physicians are given test results within 36 hours of submitting a patient’s sample.

Assurex Health has grown from 40 employees three years ago to more than 235 employees today. In 2014, genotype testing had been done on 120,000 patients, and the numbers double each year.

James S. Burns, executive chairman of Assurex Health, says, “The growth reflects the improved clinical and cost benefits from using GeneSight in patient applications.”

Physicians who were once impeded by not knowing what works best for which patients now have the advantage of GeneSight Psychotropic. Mayo Clinic technology has taken the guesswork out of predicting patients’ vulnerability to experiencing specific types of reactions from specific medications.