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Avera Health Publishes Clinical Validation of PGx Panel for Depression Treatment Optimization


NEW YORK — A pharmacogenomic panel developed at Avera Health showed an overall clinical benefit when used within the health system to guide therapy for patients suffering from depression, according to a study published last month.

Patients who received pharmacogenetic results and related pharmacist recommendations experienced improvements in mental quality of life, depression severity, and clinical outcomes, found the study, published in the Pharmacogenomics Journal.

Moreover, patients who received pharmacogenetic results four weeks after the study's initiation experienced these benefits more quickly than patients who received results 12 weeks after baseline.

The findings suggest that patient outcomes could be improved if pharmacogenomic testing was used "more upfront," said Krista Bohlen, director of personalized pharmaceutical medicine at the Avera Institute for Human Genetics (AIHG) and a lead author on the study. "We're doing further investigations," she said. But "we'd like it to be considered earlier. Don't wait until the patient's been through so many lines of therapy."

The study used the GeneFolio Pharmacogenomic Panel, a test developed by AIHG, an in-house human molecular genetics laboratory at Sioux Falls, South Dakota-based Avera Health.

For the study, researchers from AIHG, the University of South Dakota, Sanford School of Medicine, and RTI International randomized patients treated in primary care or psychiatric settings to receive a pharmacogenetic report either four or 12 weeks after study enrollment. Pharmacists would also produce recommendations for patients' providers.

Mental quality of life, depression severity, and depression symptoms were improved across patients, regardless of timing or provider type.

However, researchers saw quicker improvements in depression severity scores for patients who received pharmacogenetic recommendations after four weeks based on the "patient health questionnaire" (PHQ-9) or Becks Depression Inventory (BD) questionnaires. Depression severity also seemed to decrease faster for patients treated by psychiatrists.

Average mental quality of life increased over time, but increased more slowly for patients taking medications flagged as having serious drug-drug-gene interactions, which considers a drug's interaction with other medications a patient might be taking. It's critical to look at "the whole picture for the patient," Bohlen said.

The study was designed to address lack of consensus over when to perform pharmacogenomic testing for patients with depression.

"How many lines should [a patient] have failed before you consider it?" Bohlen said.

It's become common for health systems to offer at least some pharmacogenomic testing for patients in cases where there's established evidence, said Alexander Shlyankevich, a senior healthcare analyst at market research firm Forrester. But most organizations outsource testing to other companies, and don't do such testing themselves. Pharmacogenomic testing has become a massive industry with products offered by major industry players, including clinical laboratories and companies like 23andMe and LetsGetChecked.

Bringing such testing in house can give health systems more control over the process and timeline of when results are returned to patients and providers, Shlyankevich said.

AIHG has performed pharmacogenomic testing for more than 16,000 patients to date, according to Bohlen. The institute launched the pharmacogenomic panel branded as GeneFolio in 2017, but started pharmacogenomic testing for patients in 2014 and began developing the test even earlier.

"As we were first beginning this, there weren't a lot of outside companies available to us," Bohlen said. They wanted to be able to integrate findings directly into physicians' workflows — including into the electronic health record (EHR) system and adding clinical decision support alerts — but the companies they came across tended to issue the pharmacogenomic reports separate from other systems.

They also wanted the flexibility to add new genetic markers to their testing panel as research emerged, rather than being dependent on a third-party company adding it to their product.

Today, GeneFolio is available to patients of Avera Health and must be ordered by a clinician.

GeneFolio started with a focus on behavioral health and has expanded to patients being treated for cardiovascular disease, who have acute or chronic pain, who are managing high cholesterol, or who take at least five medications, among other issues. The test starts at $179, with additional lab fees, and Avera Health accepts insurance that may cover the cost of the test. In some cases, insurers may let patients use money from Flexible Spending Accounts and Health Savings Accounts for GeneFolio, according to an Avera Health website.

The test requires collecting a blood or saliva sample, which is sent to the CLIA-certified and CAP-accredited AIHG lab in Sioux Falls and analyzed by Avera Health geneticists. Results are based on guidelines from organizations like the Clinical Pharmacogenetics Implementation Consortium and the US Food and Drug Administration.

Physicians drawing on pharmacogenomics should think of it as an educational tool, Tim Soundy, a child and adolescent psychiatrist at Avera Health and chair of psychiatry at the University of South Dakota, who was involved with developing GeneFolio. Test results don't make the ultimate decision on which medications to prescribe a patient, so it's critical to understand pharmacogenomic results and how to apply them.

"Just because somebody's a non-metabolizer doesn't mean that we can't use a drug," he said. It could just mean they need a lower dose. "Or, if they're a rapid metabolizer, maybe they need more medication," he added. "It's a tool you can use. Pharmacogenomic testing is kind of like a scalpel in the hand of a surgeon."

He said he typically orders pharmacogenomic testing for patients who don't respond to multiple medications or who experience unusual side effects.

To help explain some of that information, Avera Health ties pharmacists into its pharmacogenomic testing process. Test results and recommendations are shared with the ordering physician through Avera Health's EHR system, and beyond the report, pharmacists also consult with physicians on drug-drug-gene interactions — considering a patient's entire medication list — and discuss other pharmacogenetic research physicians might have come across.

"The pharmacist provides explanation as to what is the issue," Bohlen said, giving input into whether a physician might want to consider a different medication, or whether it's OK to use a drug at risk for a poor interaction with additional monitoring. They're "trying to give the context of what's the risk to the patient and what actions should be taken."