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AssureRx Updates PGx Test for Assessing Best Responders to Psychotropic Drugs


By Turna Ray

AssureRx Health has made improvements to its GeneSightRx pharmacogenetic testing program for psychotropic drugs, including increasing the number of therapies on the test panel and launching a mobile device application that gives doctors more flexibility when ordering and viewing test results.

GeneSightRx is a testing service that helps doctors identify antipsychotics and antidepressants to which their psychiatric patients will most likely respond . The test determines personalized treatment options for patients by combining PGx data from peer-reviewed scientific and clinical publications, information from drug labels, pharmacology data, and the genetic profile of patients.

The testing service begins in the physician's office, where doctors can obtain a biological sample from the patient with a cheek swab. The physician then mails the sample to AssureRx's CLIA-certified, CAP-accredited lab in Mason, Ohio, for analysis. After the sample is analyzed on the Luminex 200 platform, AssureRx returns the test results to the ordering physician within 24 hours over a secure web portal.

The technology underlying GeneSightRx was developed by Cincinnati Children's Hospital Medical Center and Mayo Clinic. AssureRx licensed the core technology from these institutions and launched version 1.0 of GeneSightRx as an LDT in 2009 (PGx Reporter 10/27/2009). Since then, the company has updated the test eight times to add new genes, new drugs, or update the technology platform.

"We're moving to make it easier and easier for clinicians to use the technology," AssureRx CEO James Burns told PGx Reporter this week.

One of the improvements in version 1.8 is a feature intended to facilitate integration of test results with electronic health records and other IT systems. "We can integrate [the service] with any electronic platform at this point … at a clinician's practice, at hospitals, for payors, or for health information exchanges," Burns said.

The second improvement to version 1.8 enables physicians to order tests and receive results on mobile devices, such as a smartphone or tablet.

Finally, the new version of the testing service now gauges patients' response to six additional psychotropic medications. The test now covers a panel of 32 medications, 20 of which are antidepressants and 12 are antipsychotics. Previous versions of the test interrogated 26 medications. According to Burns, the drugs in the test panel comprise between 80 percent and 90 percent of the antipsychotics and antidepressants prescribed today.

As the science advances, AssureRx plans to continually update the test's panel of drugs and genes, and improve the technology platform.

"There's a definite process in place for updating the test at our company, and at our technology partners Mayo and Cincinnati Children's," Burns said. "All three of us use natural language processing to comb the literature, sort through and analyze key publications, and, where appropriate, incorporate new genetic content or new medications to the test."

AssureRx has no plans currently to garner marketing approval from the US Food and Drug Administration for GeneSightRx. The company feels that given the pace of advancements in the molecular diagnostics market, keeping GeneSightRx an LDT that is performed in a CLIA-certified lab is the right move.

AssureRx is marketing GeneSightRx with a team of 15 sales representatives who reach out to doctors at academic centers and in community practices. "Since we launched the test, we've had more and more community practices, whether they are hospitals or group practices, sign on to the service," Burns said. "So, now we have a really good mix of academic medical centers, community hospitals, group practices, and structured out-patient programs. So, the adoption has been pretty rapid, but broad based."

In 2010, Diamond Healthcare, a behavioral health and chemical dependency services company headquartered in Richmond, Va., began rolling out GeneSightRx in 10 of its nationwide behavioral health units. Diamond at the time said it planned to expand adoption of the test within its 30-state network in the coming years (PGx Reporter 9/28/2010).

PGx tests often encounter an uphill battle once they hit the market. Depending on the test, the disease setting, and the current standard of care, physicians in many situations have expressed discomfort incorporating genetic testing routinely into the care of their patients. The price of the test, evolving science, and uncertain regulatory and reimbursement policies all add to doctors' hesitation to use such tests.

However, the lack of patient response to psychotropic drugs is a well-known problem, which likely makes doctors more willing to try a new genetic test that might help them decide the right treatment strategy for patients. According to AssureRx, although 200 million scripts for antidepressants are filled each year in the US, the failure rate for such drugs is as high as 50 percent.

Although AssureRx initially expected physicians to be reluctant to adopt GeneSightRx, "it turns out clinicians understand the limitations of the trial-and-error method to prescribing," Burns noted. "So, they have been waiting for some time for some objective, evidence-based standards upon which they can start to figure out more rational treatment programs."

Most of the doctors that AssureRx has encountered are generally educated about the concept of how a person's genes can influence their response to drugs. "The biggest surprise to them is when they think [genetic tests] are five or 10 years away, and they realize that the technology is here today," Burns said. "Then it doesn't take them long to sign on."

Doctors have expressed concern, however, about whether GeneSightRx is reimbursed by insurance, and how much patients will have to pay out of pocket. Burns said that GeneSightRx is reimbursed by several private insurers and by Medicare, but wouldn't say how many potential lives may be covered by contracts the company has in place with payors. In the meantime, the company provides financial assistance to patients under certain circumstances.

If the test is covered by the patient's insurance provider, or if the patient qualifies for assistance from the company, the average out-of-pocket expense for the test is in the range of $50 to $100, Burns estimated. He wouldn't provide a list price for GeneSightRx, however.

Reimbursement for and physician adoption of GeneSightRx may be bolstered if the results of a 2,000-patient study by pharmacy benefit manager Medco yields positive results.

Last year, Medco and AssureRx launched the PGx-Directed Prescribing of Psychotropic Medications pilot project, or PREDICT PSYMEDS. In that study, Medco will investigate whether its members are more willing to take and remain compliant with antidepressant and antipsychotic drugs prescribed to them based on a genetic test that suggests they are likely to benefit from such treatment. Medco will also investigate whether doctors are willing to prescribe the testing to their patients and if they factor in genetic data in determining which drugs their patients should take (PGx Reporter 5/18/2011).

The project is slated for completion by mid-2013.

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