“We’re right at the beginnings of something really important; we’re just hitting the tip of the iceberg (in personalized medicine),” said Dr. John Hawkins, practicing psychiatrist and chief medical officer at Lindner Center of HOPE in Mason, an early adopter of the genetic test.
The testing determines which medicines a person will best respond to, resulting in improved health outcomes and cost savings to the patient and health care system.
What first started as about six guys working in a garage years ago has now grown to testing over 150,000 patients nationally — including 68,000 in 2014 alone, Lewis said.
“We’re on this sudden surge,” Lewis said. “The whole space of mental health is an unmet need.”
The Journal-News previously reported the company is building a new, $15 million, 60,000-square-foot headquarters in Mason.
The test, known as GeneSight, analyzes eight genes of a person’s DNA from a simple check swab to determine what that individual’s likely response and exposure level, or rate of metabolism, will be to 38 different anti-depressants and anti-psychotics.
The genomic testing technology — which originated at the Mayo Clinic and Cincinnati Children’s Hospital Medical Center — is exclusively licensed and patented by Assurex Health.
Those medications — used to treat depression, bipolar disorder, anxiety and schizophrenia among others — are then ranked in categories of green (for best response), down to yellow and red (for least effective).
Those easy-to-read results are used by the physician or provider to aid in their prescribing decisions.
“There are so many products and not all work,” Lewis said. “Genetic testing is becoming much more popular. If you can personalize it, you’re more likely to get a response (from the patient).”
In fact, Assurex Health has completed five clinical studies that evidence the improved health outcomes and cost savings to the health care system. Another 10 clinical trials are in progress.
Studies found the GeneSight test doubles a patient’s chance the chosen medications will work, said Bryan Dechairo, senior vice president, medical affairs and clinical development at Assurex Health.
Clinical trials also revealed patients that had been using a medication categorized as “red” by the genetic test had three times the medical absences from work; 69 percent more health care visits; four times the number of disability claims; and spent $5,188 more per year on health costs, according to Dechairo.
Lewis said the studies also found that 30 percent of the time, patients had been prescribed “red” medications.
“We’re trying to remove that trial and error,” Lewis said.
Hawkins said the Lindner Center, a mental health and addiction hospital, first participated in market testing for Assurex Health by trying the test free for 100 patients to see how clinicians liked it. Five years later, “we’ve used the product hundreds of times, purely driven by the benefit clinicians see,” Hawkins said.
Currently, Lindner Center of HOPE orders the tests for mental health patients with either a lack of response to their previous or present medications or a lack of tolerability, or side effects.
“Then we can give the patient an explanation and it guides us to change medications,” Hawkins said.
Hawkins said the GeneSight results are an “additive” to the treatment phase, along with first an accurate diagnosis and family history.
“It’s rapidly becoming a critical part of the assessment of folks,” Hawkins said.
There are over 10,000 providers nationally, including physicians, nurse practitioners and physician’s assistants, that order the GeneSight test for patients. The GeneSight test is now covered under Medicare and the Veterans Affairs.
“Psychiatrists have never had a test like this,” Dechairo said.
Patient testimonies, shared with Assurex Health and physicians like Hawkins, have included those who struggled through multiple medications, psychiatrists and hospitalizations before seeing positive outcomes. Hawkins said he’s had patients close to giving up on treatment due to “frustrations” when medicines didn’t work.
“I can’t emphasis enough the value this test has brought to people who’ve struggled,” Hawkins said. “It’s a saving grace.”
Lewis said for now, Assurex Health remains solely focused in mental and behavioral health. GeneSight also analyzes a person’s response to 22 analgesics, or opioid and non-opioid pain pills, and eight ADHD medications.
“Pharmaceutical products don’t work in the same in everyone,” Lewis said. “Personalized medicine is the pathway of the future.”
How it works
The DNA test results are turned around in 36 hours to a secure Web portal. The lab in Mason tests patients from all states, with an original emphasis on Ohio, Florida, California and New York.
When a patient sample arrives at the laboratory, it first goes through quality control steps, including removing personal information and assigning a unique identifier to each sample, said Sandra Gunselman, vice president, laboratory operations.
Up to 500 samples a day are then analyzed in shifts running 7 a.m. to 11 p.m., Gunselman said.
Four robotic DNA extractors are used to extract DNA from the cotton swabs at a rate of 96 samples every 30 minutes, per machine. Gunselman said prior to the robotic machines, this was done by hand at a rate of 12 samples per day.
“It’s automation that’s really changed clinical work,” Gunselman said.
The samples then go through a polymerase chain reaction — a technique that takes one small human sample of DNA and amplifies it into 2 million copies for testing.
The eight genes tested yield up to 20,000 different genetic combinations.