IGNITE II network brings genomics into everyday care

"The goal is timeliness: getting the right information to the physician before a patient needs it. IGNITE II is helping to create the pathway."

By: Ashley Schwab .

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In the last decade, life has transformed to complete personalization. Ads, websites, clothing, car features –- anything and everything is targeted to each person. And for those parts of life that matter most, like health and well-being, the GeNomics In pracTicE (IGNITE) II research network is establishing protocols for personalizing health care through genomic medicine.

The heart of IGNITE II

IGNITE II is a multi-institutional research network funded by the National Institutes of Health (NIH). A continuation of the IGNITE I network, which ended in 2018 and aimed to design methods for incorporating genomic medicine into the clinic, IGNITE II focuses on the next step: real-world delivery of genomic medicine in diverse clinical settings.

IGNITE II is laying the foundation for integrating genomics into everyday patient care across the nation. Rather than one size fits all, doctors and scientists can use genetic testing and evaluation to determine a patient’s needs throughout his or her lifetime.

Five main sites, each with multiple affiliates, have been funded to deliver personalized health care informed by genomics through IGNITE II:

  • Vanderbilt University
  • Indiana University
  • University of Florida
  • Mount Sinai Hospital
  • Duke University

Through an affiliation with Vanderbilt University, Sanford Health worked on IGNITE I. Sanford Health has once again partnered with Vanderbilt University on IGNITE II, and the health system has received another $1 million in NIH funding to be used to bring genomic medicine to rural communities across its enterprise footprint.

An emphasis on rural communities

“When we submitted and renewed this network funding request, one of the goals of our collaboration with Vanderbilt University was to build on the momentum of IGNITE I in underserved populations,” said Russell Wilke, M.D., Ph.D., principal investigator of IGNITE II at Sanford Health.

“Sanford Health already uses genetics to improve care delivery in a variety of clinical settings,” he said. “This award increases our capability to measure the impact of genomics on quality. It will allow us to determine how many clinical events, such as heart attacks, cancers and adverse drug reactions, are avoided by deploying genetic testing in our rural communities.”

The emphasis of IGNITE II is reaching medically underserved areas. Currently, 35 percent of patients come from racial or ethnic minority, underserved or rural populations, and these are often populations with poorer medical outcomes. In the next five years, IGNITE II will establish protocols that are applicable in each of these settings across the U.S.

A dedication to prevention

“Genomic medicine has really opened the door to significantly reducing adverse events. An adverse event can be anything from a negative health outcome to a side effect from a medication. Using genetic testing to predict disease and drug response ahead of time allows doctors to develop better interventional strategies,” Dr. Wilke said.

As chair of the internal medicine department, Dr. Wilke has been internationally recognized as an expert in the genetic prediction of serious adverse drug reactions. Over the past two decades, he has been a part of three previous NIH-funded research networks focusing on drug-gene interactions:

  • PGRN (Pharmacogenetic Research Network): discovered genes that predict drug response in clinical trials
  • eMERGE (Electronic Medical Records and Genomics): validated actionable drug-gene relationships in biobanks
  • IGNITE (Implementing Genomics in Practice): implemented drug-gene relationships in routine clinical care

Now, Sanford School of Medicine is applying what has been learned from all three in IGNITE II.

The genetics behind disease risk

IGNITE-II will expand health care’s ability to predict inheritable cancers and conditions.

“IGNITE II is taking what we have learned from IGNITE I and clinical trials on genomic medicine and applying the information to clinical practice,” said Catherine Hajek, M.D., a medical geneticist and co-principal investigator of IGNITE II at Sanford Health.

“For instance, we will work hand in hand with providers to combine patient clinical information, family history and genomic information with the goal of improving risk prediction for certain cancer types,” she said. “This provides exciting potential for us to provide more personalized surveillance protocols for patients to help reduce their individual risk.”

The genetics behind drug response

The impact of genetic testing for prescribed medications is also extremely important. Many medications have serious side effects that can sometimes even be life-threatening. Examples are blood thinners, cancer medications, pain medications and antidepressants.

“Small changes in the dose of some drugs can affect whether they will be effective or toxic. Overall, we are looking at medications that have a high likelihood of hurting patients or failing if the patients carry certain gene variants (changes),” said Jordan Baye, Pharm.D., a pharmacist at Sanford Health.

“We know there are genetic variants that predict how some patients respond to certain medications,” added Lindsay Hines, Ph.D., a neuropsychologist and co-principal investigator of IGNITE II at Sanford Health. “We can identify these gene changes through genetic testing.”

Ideally, the best way to utilize pharmacogenomics is prospectively -– before starting a medication. This is especially true in rural communities where access to genetic testing can be limited. IGNITE II hopes to resolve this barrier.

“The goal is to use genetic information to improve lives, outcomes and change health care as we know it,” Baye said. “We are trying to find the right medications for each individual patient based on his or her genes. And, as we find these things, this will change medical practice. That is the paradigm shift, a change from traditional medicine to precision medicine.”

Antidepressants as an example

Antidepressant prescriptions have increased 60 percent in recent years, Dr. Hines said. In the past, a trial-and-error approach was used to find the correct medication and dosage for a patient.

“For example, there are six medications, called selective serotonin reuptake inhibitors (SSRIs), that are often used for treating depression,” Dr. Hines said. “We know that different SSRI medications work well for some people and poorly for others. Before pharmacogenetics, it often took a long time to find a medication that would work without creating negative side effect.”

“About half of patients get the right medication the first time. But, unfortunately, up to half experience side effects because the medication or dose is not right. There is such a high percentage of people who stop taking antidepressant medication because of side effects,” Dr. Hines said.

Studies show that when patients quit one medication due to side effects, they are less likely to take a second medication. They would rather deal with the symptoms of depression than the side effects of the medication. This becomes a huge challenge in the treatment of this common clinical problem.

“By partnering together with primary care doctors and specialists,” Dr. Hajek said. “The next five years of IGNITE II will be dedicated to seeing if what has been discovered and reported so far about genomics can be used in all clinical settings and diverse environments.”

“The goal is timeliness: getting the right information to the physician before a patient needs it. IGNITE II is helping to create the pathway,” Dr. Wilke said.