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

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

NEW YORK — A pharmacogenomic panel developed at Avera Health has shown overall clinical benefit when used within the healthcare system to guide treatment for patients with 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, the study, published in the Pharmacogenomics Journal, found.

Additionally, patients who received the pharmacogenetic results four weeks into the study experienced these benefits more quickly than patients who received the results 12 weeks into the study.

The findings suggest that patient outcomes could be improved if pharmacogenomic testing was used “more upstream,” said Krista Bohlen, director of personalized pharmaceutical medicine at the Avera Institute for Human Genetics (AIHG) and lead author of the study. ‘study. “We are conducting other investigations,” she said. But “we would like this to be considered sooner. Don’t wait until the patient has crossed so many lines of therapy.”

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

For the study, researchers from the AIHG, 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 four or 12 weeks after study enrollment. Pharmacists would also produce recommendations for patients’ caregivers.

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

However, researchers observed more rapid improvements in depression severity scores in patients who received pharmacogenetic recommendations after four weeks based on the “Patient Health Questionnaire” (PHQ-9) or questionnaires. the Becks Depression Inventory (BD). The severity of depression also seemed to decrease more rapidly in patients treated by psychiatrists.

Mean mental quality of life increased over time, but increased more slowly for patients taking drugs reported to have serious drug-drug-gene interactions, which takes into account the interaction of a drug with other 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 the lack of consensus on when to perform pharmacogenomic testing for patients with depression.

“How many lines does it take [a patient] failed before you considered it?” Bohlen said.

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

Setting up such tests in-house can give health systems more control over the process and timing of returning results 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 pharmacogenomics panel under the GeneFolio brand in 2017, but began pharmacogenomics testing for patients in 2014 and began developing the test even earlier.

“In the beginning, we didn’t have a lot of outside companies available to us,” Bohlen said. They wanted to be able to integrate results directly into physician workflows – including the electronic health record (EHR) system and adding clinical decision support alerts – but the companies they met with had tendency to publish pharmacogenomic reports separately from other systems.

They also wanted the ability to add new genetic markers to their test panel as research emerged, rather than depending on a third-party company to add them to their product.

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

GeneFolio began with a focus on behavioral health and expanded to include patients being treated for cardiovascular disease, suffering from acute or chronic pain, managing high cholesterol, or taking five or more medications, among other issues. The test starts at $179, with additional lab fees, and Avera Health accepts insurance that can cover the cost of the test. In some cases, insurers may allow patients to use money from flexible spending accounts and health savings accounts for GeneFolio, according to an Avera Health website.

The test requires the collection of a blood or saliva sample, which is sent to the CLIA-certified and CAP-accredited AIHG laboratory in Sioux Falls and analyzed by Avera Health geneticists. The results are based on guidelines from organizations such as the Clinical Pharmacogenetics Implementation Consortium and the United States Food and Drug Administration.

Physicians who rely on pharmacogenomics should view it as an educational tool, Tim Soundy, child and adolescent psychiatrist at Avera Health and chair of psychiatry at the University of South Dakota, who helped develop by GeneFolio. Test results do not make the final decision on which drugs to prescribe to a patient, so it is essential to understand pharmacogenomic results and how to apply them.

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

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

To help explain some of this information, Avera Health involves pharmacists in its pharmacogenomics testing process. Test results and recommendations are shared with the prescribing physician through Avera Health’s EHR system, and beyond the report, pharmacists also consult with physicians on drug-drug-gene interactions – taking into account the list completes a patient’s medications – and discuss other pharmacogenetic research physicians who might have come from the other side.

“The pharmacist provides an explanation of the problem,” Bohlen said, indicating whether a doctor might consider a different drug or whether it’s okay to use a drug that’s at risk for poor interaction with additional monitoring. They “try to give the context of the risk to the patient and the measures to be taken”.

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