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Assurex, Mental Health Center Receive Grant to Study GeneSight Clinical Utility in Canada


Originally published Oct. 19.

NEW YORK (GenomeWeb) – With a $6 million grant from government agency Genome Canada, Assurex Health and Canada's Centre for Addiction and Mental Health (CAMH) will study whether using the GeneSight Psychotropic test to guide treatment decisions for depressed and schizophrenic patients helps improve their outcomes and saves money.

GeneSight Psychotropic analyzes genomic variants in mental health patients associated with their ability to respond to more than 30 drugs. Assurex markets the test as a tool physicians can use to select the treatment that will most likely benefit their patients with depression, anxiety, bipolar disorder, schizophrenia, and other neuropsychiatric conditions.

According to Assurex and CAMH, this is the first study to investigate the clinical usefulness of pharmacogenomics information in Canadian mental health patients. The grant funds a joint Genomic Applications Partnership Program that CAMH and Assurex Health will manage together, while the Ontario Genomic Institute will provide administrative support.

The partnership with CAMH has also facilitated Assurex's first international expansion, Assurex CEO Virginia Drosos told PGx Reporter. Almost a year ago, Assurex and CAMH inked a public-private partnership and formed AssureRx Canada operates as a subsidiary of Assurex Health, but CAMH holds a minority equity share in the joint venture.

Through this deal, Mason, Ohio-based Assurex has set up a Canadian office in Toronto and a certified clinical lab at CAMH. Assurex partnered with CAMH not only eyeing the expansion of GeneSight Psychotropic into the Canadian market, but also looking to improve the test with drug-related adverse event markers discovered by CAMH. Under the terms of their arrangement, CAMH will receive royalties on sales of tests that include markers it has discovered.

Assurex's growth plans are further bolstered by this latest funding bolus from Genome Canada. With the $6 million doled out over three years, researchers are planning to conduct a blinded, randomized 12-week study, entitled “Clinical Utility and Enhancements of a Pharmacogenomics Decision Support Tool for Mental Health Patients,” at 10 sites in Ontario and enroll 1,200 patients, mainly from Toronto.

Researchers from Assurex and CAMH are planning to enroll in the study patients with schizophrenia and depression who have failed to respond to treatments and randomize them into three groups. For one group, doctors will administer treatment with the help of GeneSight Psychotropic; for the second group, doctors will guide treatment based on GeneSight and additional drug adverse event-associated markers discovered by CAMH; and for the last group, doctors will guide treatment decisions normally, without any genetic data.

In comparing the three groups, investigators are aiming to gauge whether the use of the PGx data improves patients' health by guiding them to the most appropriate medications quickly and whether such data saves the healthcare system money by avoiding costs related to adverse reactions or drugs that lack efficacy in patients.

With a presence in the US and in Canada, Assurex is hoping to market its GeneSight test to the approximately 60 million people who are on a psychotropic, ADHD, or analgesic drug. Assurex cited data that each year one in five Canadians suffer from mental illness or from addiction. The disease burden costs the healthcare system $51 billion from healthcare costs, productivity loss, and diminished quality of life.

Assurex has already built a body of evidence backing the clinical utility of GeneSight Psychotropic, but most of that data comes from the US population. Studies conducted by the company have shown that using GeneSight Psychotropic to predict which antidepressants patients will respond to improves their depressive symptoms by 70 percent and reduces healthcare costs by 28 percent.

Based on this evidence, Assurex has netted reimbursement contracts with a number of US payors, Medicare and Medicaid, and is hoping to garner similar acceptance within the Canadian healthcare system. This study with CAMH, if successful, may also help enhance Assurex's panel of markers for the test.

"If the results also demonstrate improvement in the side effects of anti-psychotic-induced weight gain for those patients guided by the enhanced Genesight test, then that would warrant adding those weight gain predictive markers to the combinatorial GeneSight product," C. Anthony Altar, senior VP of neurosciences at Assurex, told PGx Reporter. "We anticipate that additional gene variants will also be discovered for their ability to predict outcomes of patients in these studies, paving the way for future additions of genetic variants to the combinatorial GeneSight product.”

For the time being, GeneSight is available to Canadian patients though the research partnership between CAMH and Assurex. "Canadians can access GeneSight testing as part of clinical studies at CAMH," Drosos told PGx Reporter, adding, "We certainly hope to make GeneSight broadly available for people in Canada within the next several years.”

Although the international market for GeneSight Psychotropic is still small, Drosos noted that the company is hoping to eventually expand access to the test globally and ink more international research partnerships like the one with CAMH.

In addition to GeneSight Psychotropic, Assurex markets GeneSight Analgesic, a test that personalizes treatments for people with chronic pain. In August, Assurex announced that 100,000 mental health and chronic pain patients have received testing on its GeneSight products. Approximately 8,500 doctors at a variety of healthcare settings are registered to offer testing with GeneSight.

Testing volume has doubled since 2012, and Assurex expects it to double again this year. The company is aiming to test up to 1 million patients by 2018.

In May, Assurex announced that it had secured $32 million in financing from GE Capital, Silicon Valley Bank, Sequoia Capital, Claremont Creek Ventures, Mayo Clinic, Cincinnati Children’s Hospital Medical Center, CincyTech and Allos Ventures, which will likely help bolster marketing efforts and fund test improvements. In July, Assurex established a contract with the US Department of Veterans Affairs where doctors will be able to order GeneSight Psychotropic for veterans through June 2019.