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PREDICT program expands, opens new Genomics Clinic

Apr. 30, 2020, 10:10 AM

Medical laboratory scientist Gladys Garrison, MT, MS, loads reagents to prepare DNA samples for analysis in the VUMC Molecular Diagnostics Lab.
Medical laboratory scientist Gladys Garrison, MT, MS, loads reagents to prepare DNA samples for analysis in the VUMC Molecular Diagnostics Lab. (photo by Susan Urmy)

by Bill Snyder

A new clinic opening at Vanderbilt University Medical Center will help doctors and patients choose the best drugs for their medical conditions based on the patients’ unique genetic makeup.

The Genomics and Therapeutics Clinic initially will accept referrals from VUMC providers and patients, and will schedule telemedicine visits every other Thursday morning beginning May 7. After the COVID-19 pandemic is brought under control, the clinic will open for in-person visits at Vanderbilt One Hundred Oaks.

The clinic opening coincides with a major expansion of PREDICT, VUMC’s Pharmacogenomic Resource for Enhanced Decisions in Care and Treatment, which for the past decade has helped physicians predict, through genetic testing, how their patients will respond to commonly prescribed medications.

Six new drug-gene interactions have been added to the PREDICT panel, five of which test for genetic variations that affect response to a class of drugs prescribed for anxiety, depression and other psychiatric disorders.

VUMC researchers also will participate later this year in a multicenter clinical trial aimed at improving treatment of depression and acute and chronic pain.

“The development of the Genomics and Therapeutics Clinic represents a key next step in VUMC’s long-standing commitment to incorporate pharmacogenomic testing into routine care of our patients,” said Dan Roden, MD, Senior Vice President for Personalized Medicine at VUMC who helped design and launch PREDICT in 2010.

“Vanderbilt has the ability to support clinicians in precision health initiatives in a way that is unmatched in other institutions,” added Sara Van Driest, MD, PhD, assistant professor of Pediatrics and Medicine.

The Genomics and Therapeutics Clinic will provide a resource for physicians and patients who have questions about pharmacogenomic testing, whether it’s appropriate in their case, for example, or how best to apply test results to their medication plan.

Van Driest helped develop and will provide consultative services through the Genomics and Therapeutics Clinic with Andrea Ramirez, MD, MSCI, assistant professor of Medicine, and Michelle Liu, PharmD, BCPS, clinical pharmacist specialist in pharmacogenomics.

Ramirez and Van Driest both trained in Clinical Pharmacology at VUMC and will co-direct the clinic. Ramirez also practices clinical endocrinology and studies the genetics of diabetes. Liu, a board-certified Pharmacotherapy Specialist, joined VUMC last year after completing a pharmacogenomics fellowship at Long Island University in Brooklyn, NY.

The ultimate goal, said Van Driest, is to reduce the time patients are on medications that are not working for them as well as to limit the cost and number of visits required to find the right drug. For more information about the clinic, email GATC@vumc.org.

Currently in the PREDICT program, blood samples from patients are screened for 33 common genetic polymorphisms, or variations, within eight genes. These genetic variants can affect how well drugs are absorbed and broken down and how long they stay in the body.

With the recent addition of gene-drug interactions for five antidepressant SSRIs (Selective Serotonin Reuptake Inhibitors) and one for ondansetron (Zofran), which is often given to combat nausea in patients on the oncology and post-anesthesia units, a total of 16 drugs have clinical decision support for genotype-guided prescribing through PREDICT.

“This expansion will provide critical support for the unique challenges that these patients and providers experience,” Van Driest said.

Information from patients’ genetic “readout,” their genotypes, is included in their electronic health records. Physicians can check their patients’ records for gene-drug interactions before prescribing medications for them.

If doctors don’t check for these “genomic indicators” and order a drug that may be ineffective or cause serious side effects due to the patient’s genetic makeup, they will receive an electronic alert recommending that they choose another medication.

Providers can order a consult if they have questions about the recommendation. The consult option is built into the alerts for the SSRIs and ondansetron alongside the alternative medications.

If the alternative medications are not what providers want to choose for their patients, through the consult “I can help address their concerns and come up with a solution,” Van Driest said.

VUMC patients also can access their genetic test results through the MyHealth at Vanderbilt portal, and share those results with medical providers outside of the VUMC system.

For more information about the PREDICT program and the drug-gene interactions it supports, please visit www.mydruggenome.org.

For VUMC clinicians who would like to learn more about ordering a PREDICT test, sign into Hubble at https://hubble.app.vumc.org/web and search for PREDICT under the Tip Sheets tab, or email predict@vumc.org.

Since PREDICT was launched in 2010, the testing platform, or the method by which testing for gene-drug interactions is conducted, has undergone two transformations as assay reagents and instruments used in the testing have changed to coincide with the addition of new genetic variants and associated drug-gene interactions.

The testing is conducted in the VUMC Molecular Diagnostics Lab, where Cindy Vnencak-Jones, PhD, the lab’s medical director and professor of Pathology, Microbiology and Immunology, and Gladys Garrison, MS, the lab’s team leader, oversee a staff of 10 medical laboratory scientists, five of whom are trained on the PREDICT platform.

“This is not an FDA-approved kit but rather a laboratory-developed test,” Vnencak-Jones explained. “You have to take different reagents that you purchase and put them together to create a clinical test, validating its sensitivity, specificity, accuracy and reproducibility prior to using it in patient testing.”

“PREDICT represents less than 5% of our total work,” she added. “We can handle increased volume with no problem. We’ve been working on PREDICT for about nine years. It’s our baby as well. It’s been a whole lot of work … but we’re excited to be involved in it.

“Our ability to enable genome-driven precision medicine for pharmacogenetics,” said Vnencak-Jones, “is just at the tip of the iceberg.”

Roden, professor of Medicine, Biomedical Informatics and Pharmacology, who holds the endowed Sam L. Clark, MD, PhD Chair in the School of Medicine, agrees.

“Most people will do just fine with an average dose of an average drug,” he said. “What we’re trying to do here is find the people who are at the edges of the distributions, the people who are not going to do well, find them and do something different for them.”

This is a difficult challenge. For an institution like VUMC to do it well requires absolute, top-to-bottom commitment.

“The pathologists, the informaticists, the clinicians — everybody has to be on board with the idea that we’re doing the right thing for our patients,” Roden said.

 

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