Summary of Clinical Studies
The clinical validity, clinical utility and economic utility of the GeneSight® Psychotropic test is supported by six clinical studies published in peer-reviewed journals. In fact, it’s the only neuropsychiatric pharmacogenomics test backed by such extensive research. Read on to learn more.
Clinical Study #1: 50% improvement in remission rates
Study Design: This was a 24 week, blinded, multi-center, randomized controlled trial of 1,167 subjects with major depressive disorder from 20 academic sites and 40 community sites.* The study assessed the impact of the GeneSight Psychotropic test on psychiatric treatment response compared to unguided treatment as usual (TAU).
* Minimum Score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17)
Significant improvement in remission and response: Patients receiving the GeneSight Psychotropic test experienced a 50% improvement in remission rates and a 30% increase in response rates at week 8 compared to TAU. Additionally, symptom improvement in the GeneSight-guided group trended toward significance at week 8 compared to TAU.
The GeneSight effect on response and remission was durable over 6 months: Remission and response rates continued to increase throughout the 24 week study period.
Switching to a genetically optimal medication improves patient outcomes: Symptom improvement, response, and remission were significantly improved when patients on a genetically suboptimal medication were switched to a genetically optimal medication by week 8 compared to those who remained on genetically suboptimal medications.
Clinical Study #2: 70% greater improvement in depressive symptoms
Study Design: This was a prospective cohort study of 165 subjects with a primary diagnosis of major depressive disorder.* The study compared 8 weeks of treatment guided by GeneSight to unguided treatment as usual (TAU).
Significant improvement in depression scores: Greater reduction in depression ratings was observed across the duration of the study for the GeneSight guided group, showing 70% greater improvement in depressive symptoms compared to TAU at 8 weeks.
Higher response rates: When clinicians used the GeneSight report to guide treatment, patients were 2.1 times more likely to respond to their medications compared to treatment without GeneSight.
Higher physician and patient satisfaction: Almost three times as many physicians in the GeneSight guided group perceived their patients to be very highly satisfied with their care compared to the unguided group. Physician reporting of confidence in choice of medication and treatment and satisfaction with care was also substantially higher in the GeneSight guided group.
*Minimum Score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17). QIDS-C16 (Quick Inventory of Depressive Symptomatology-Clinician Rated) PHQ-9=Patient Health Questionnaire
Clinical Study #3: Likelihood of response more than doubled unguided treatment as usual
Study Design: This was a double-blind, randomized controlled trial of 49 subjects with a primary diagnosis of major depressive disorder.* It compared 10 weeks of treatment guided by GeneSight® with unguided treatment as usual (TAU).
*Minimum Score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17).
Higher response and remission rates: When physicians’ decisions regarding medication change were guided by GeneSight, the likelihood of response and remission was more than double the TAU group.
GeneSight can predict patients’ response to medications: GeneSight accurately predicted those patients who were more likely to have poor depression outcomes due to gene-drug interactions. TAU subjects who had been prescribed medications that were genetically sub-optimal had almost no improvement in depressive symptoms over the 10 weeks of the trial.
Genetically optimal medications significantly improve patient outcomes: When subjects who had been on genetically sub-optimal medications were switched to a genetically optimal medication(s) based on their GeneSight® report, the subjects experienced a 33.1% improvement in symptoms (HAM-D17) at ten weeks compared to red category TAU subjects who had 0.8% improvement.
Patients benefit when clinicians have access to meaningful pharmacogenomic information: Depression outcomes improved for patients when clinicians were provided and acted on pharmacogenomic information to make genetically appropriate treatment adjustments.
Clinical Study #4: Up to a 4-fold greater improvement in depressive symptoms
Study Design: This was a prospective cohort study of 44 adults with a primary diagnosis of major depressive disorder.* The study compared 8 weeks of treatment guided by GeneSight® to unguided treatment as usual (TAU).
Faster time to improvement: Physician medication changes guided by GeneSight pharmacogenomic testing improved time to depression symptom relief compared to current standard of care.
Genetically optimal medications prescribed more often: When clinicians used GeneSight to guide treatment, subjects were more often prescribed medications identified as genetically optimal for that subject.
Improved clinical outcomes: This study showed a 4-fold greater improvement in subjects’ depressive symptoms at week 8 (QIDS-C16) when treatment was informed by GeneSight compared to treatment as usual (TAU).
*Minimum Score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17).
Clinical Study #5: Saved an average of $1,036 per patient per year in total medication costs.
Study Design: Pharmacy claims were compared over one year between a cohort of GeneSight tested subjects (n = 2,168 enrolled) and a control group (n = 10,880). Both groups were followed for 365 days after the date of project enrollment. Prescription medication claims data was analyzed for differences between the two groups and within the GeneSight group based on medication changes that were congruent or non-congruent with each individual’s GeneSight results.
Significant annual savings are realized when healthcare providers use GeneSight test results to guide treatment decisions: Patients who received GeneSight testing saved $1,035.60 in total annual medication costs compared to TAU patients. Total annual medication savings were $714.24 (69%) for non-CNS medications and $321.36 (31%) for CNS medications.
Improvement in Adherence: An increase in medication adherence of 17% was observed in the GeneSight group (p < 0.0001) for the medication prescribed after enrollment compared to the medication prescribed prior to enrollment.
Reduced Polypharmacy: One in five patients in the GeneSight group were on less medications by the end of the study (significantly greater than the empiric prescribing cohort, p < 0.0001).
Provider congruence with GeneSight report recommendations results in lower medication costs: GeneSight guided patients with congruent medication regimens saw an average of $2,774.53 in net annual cost savings compared to patients with incongruent medication regimens.
Works across Practice Settings and Conditions: Both psychiatrists and non-psychiatrists who had access to GeneSight information saw average savings of over $1,000 per patient. Savings for major depressive disorder, anxiety, and bipolar disorder conditions averaged over $1,000. GeneSight cost savings effect increases as a function of congruence with the report.
Clinical Study #6: Healthcare costs rise > $5,000 a year when patients take genetically suboptimal medications
Study Design: The effect on health care utilization when prescribed a red category (genetically discordant) medication was evaluated in a 1-year, blinded, retrospective study of 96 subjects with a DSM-IV-TR diagnosis of depression or anxiety disorder.
Healthcare costs rise when patients’ treatment plans do not match their genetic profiles: Patients taking GeneSight evaluated red category (genetically discordant) medications had a 69% increase in total healthcare visits and 4 times higher disability claims compared to patients on genetically optimal (green category) medications.
Employee productivity decreases when patients’ treatment plans do not match their genetic profiles: There is a 3-fold increase in medical absence days between patients on red category medications and those on green category medications.
Switching patients to genetically optimal medications may decrease healthcare costs: When subjects were taking genetically discordant medications (red category medications), their total healthcare utilization costs were $5,188 higher per patient per year than subjects on genetically optimal medications.
See what happens when the GeneSight® test becomes part of a clinician’s practice.
GeneSight® Psychotropic is a pharmacogenomic test that uses a proprietary algorithm to analyze 12 different genes to weigh their combined influence on patient response to different psychotropic medications. Most neuropsychiatric medications are processed through multiple metabolic pathways, and genomic variants influence both metabolism and response. Unlike other tests, the GeneSight Psychotropic test uses a proprietary combinatorial pharmacogenomic approach, which measures multiple genomic variants for each patient and weights them in combination to provide comprehensive, genetically-driven recommendations for each medication.
The GeneSight® test provides information on FDA-approved medications prescribed for depression and analyzes how your patient’s genes may affect their response to these medications.
Ready to offer your patients the GeneSight® Test?
Implementing the GeneSight test in your practice is simple. Get started by calling us at 866.757.9204.
Ordering a GeneSight test is fast and efficient:
A simple buccal swab is used to quickly collect a sample of your patient’s DNA. Just put the swabs in a prepaid FedEx envelope and send them to our lab.
About 36 hours after we receive the sample, you can access your patient’s personalized report on the secure GeneSight® website.
Watch and Learn
Stay up-to-date on the latest research with Chalk Talk, our educational webinar series. Chalk Talk provides valuable information and insight about developments in the treatment of depression, pharmacogenomics and the GeneSight® test.