One opioid prescription can be all it takes to launch into the downward spiral of addiction.
Pro-GeneX, a pharmacogenomics company in Gainesville, aims to offer a tool for physicians to help them better gauge a person’s propensity for opioid addiction, before writing the prescription.
“Our goal when we’re finished, is to have a deliverable for physicians that will use genetic information and an algorithm to produce a risk score,” Robbie Rupard, CEO of Pro-GeneX said. “This will give a doctor comfort when they feel like they need to give a little bit more, and give them caution when they’ve got one to worry about.”
Rupard and Brett Grauss, CEO of Pro-GeneX Laboratories, established the company more than four years ago and have continued to provide individualized genetic profiles for patients. They do this by analyzing a person’s DNA and putting the results into a program, which gives a list of medications that work for the specific patient.
Rupard said he built the lab with Grauss with the intentions of “getting a genetic test done cheaper.” After accomplishing this feat, they looked toward broadening the scope of the company’s impact.
That’s when Rupard and Grauss came across a 2017 case study conducted by a research group at Pennsylvania State University. The study provided a predictive score for a patient’s genetic risk for opioid addiction. The team gathered data through analyzing DNA from 37 patients with prescription opioid or heroin addiction, and 30 age and gender matched controls.
Rupard said through looking at the study’s sensitivity, specificity and predictive score, he felt confident in the data.
“We thought, ‘Why isn’t this in use today?’” Rupard said. “The obvious answer is the patient sample size is too small.”
Feeling inspired, Rupard and Grauss brainstormed a way to take the study to the next level. They decided to extend the population to 1,000 patients, while also cutting down on the project’s cost.
Rupard said Penn State’s 67-patient study was funded by the National Institute of Health for $690,000.
“We figured out if we got the right team members together that were of a like mindset, we could do a study on 1,000 patients for somewhere between $400,000-$500,000,” he said.
Finding the dream team
Like most who get excited about a new idea, Rupard and Grauss began to share their thoughts with those within the medical and genetics fields.
Word of Pro-GeneX’s proposed study found its way to Dr. Lynn Webster, a pain researcher and physician known for his expertise in the field of pain management. Webster serves as the vice president of scientific affairs of the research organization, PRA Health Sciences, and was the former president of the American Academy of Pain Medicine.
Rupard said Webster has developed online tools for physicians to use in determining a patient’s propensity for addiction. While Penn State examined people’s genetic links, Webster created a six-question assessment. The questionnaire asks about a patient’s personal and family history of substance abuse, age, psychological diseases and history of preadolescene sexual abuse.
After Rupard and Grauss talked with Webster about their study idea, the physician jumped on board.
“Dr. Webster has a whole system of treating the socioeconomic aspects of addiction,” Grauss said. “That, combined with a genetic panel that truly is a predictive model, can change the world, in his words.”
To make the team complete, Rupard said they needed someone to spearhead the study’s design — someone who understood genetics and health care analytics.
Nicoleta Serban, a professor in the H. Milton Stewart School of Industrial and Systems Engineering at the Georgia Institute of Technology, filled this slot.
While Pro-GeneX will conduct the DNA testing, Serban’s work involves designing the study. This includes deciding what the sample population will look like.
“This is the right direction for health care and change for me in my research interests,” Serban said. “These decision tools can lead the way in personalized medicine.”
Gathering the samples
Serban said the study’s sample population will include 500 people who have prescription opioid addiction and a control group of 500.
Pro-GeneX provides medication risk management services in long-term care and behavioral health facilities through a partnership with Primerica. Through this alliance, Rupard said his company shouldn’t have an issue collecting study participants.
He intends to start gathering the DNA samples this fall. The genetic information will be extracted through cheek swabs and sequenced at Pro-GeneX’s lab.
Rupard said the first step in the study entails identifying where to get the participants, and the second involves enrolling those people and testing them. This will then be followed by a DNA analysis, and development of the algorithm to gauge the opioid addiction risk levels.
Why people should care
Dallas Gay, one of the lead organizers of Partnership for a Drug Free Hall, said the genetic link to opioid addiction has been known for quite some time. While some people become addicted to opioids quickly and severely, he said others may not experience the same effects.
“That being the case, it would be invaluable for people to know if they have that genetic link,” Gay said. “They may not have been told of anyone in their family who has been addicted to drugs or they may not know it.”
Gay said he supports Pro-GeneX’s study because it could lead to not only informing people about their level of risk, but helping physicians who prescribe the drugs.
“Today’s opioid epidemic is so strong,” he said. “We lose 70,000 people a year in the U.S. It’s amazing how many people don’t know how big and real it is.”
Grauss said the study has a personal link to everyone at Pro-GeneX.
For years he coached youth football in Alpharetta. Grauss said he will never forget one of his former players who died from an overdose at 26 years old.
“He was fine and perfectly healthy,” he said. “He had some back injuries, and he was loaded up on Percocet and got addicted. It was just a downhill spiral from there. I think everybody in the community has a story like that.”
Now that Pro-GeneX is launching its study, Rupard said he’s excited to make a positive impact on the opioid epidemic.
“We discovered this information, and it’s not a magic bullet, there’s no such a thing in health care,” he said. “But, if we’re one step closer to a solution, and we can move the needle by 1%, the amount of people we can save is huge.”
Although Rupard and Grauss plan to come up with their own funds for the study, they’re accepting donations through the company’s nonprofit. For more information about the study or to make a donation, contact Pro-GeneX at 404-419-7915. The company is headquartered at Brenau University’s Business Incubator at 999 Chestnut St. SE in Gainesville.