Clinical Evidence and Data Supporting the Genecept Assay®

Genomind is always searching for ways to improve upon the traditional trial and error process of drug prescribing in psychiatry. As such, we have conducted and continue to conduct a number of studies in order to present objective data on how the Genecept Assay can help patients feel better, faster.

Clinical evidence has shown the Genecept Assay has resulted in better treatment response and patient compliance, as well as decreased healthcare costs. Read an overview of the highlighted publications below to learn more.

Highlighted Publications

Cost Effectiveness of Pharmacogenomic Testing in Patients with Mood and Anxiety Disorders

This case-control study looked at health care utilization and costs among patients with mood disorders and anxiety disorders following use of the Genecept Assay® (cases, N=817) compared to similar patients whose treatment was not directed by phamacogenomic testing (controls, N=2,745). Conducted in the database of a large U.S. insurer (Aetna), patients were matched by diagnosis, comorbidities, demographic features, including age, gender, socioeconomic status, and other dimensions such as duration of illness and number of prior treatment failures. In the 6 month period following testing, cases experienced fewer all-cause emergency room visits and fewer all-cause in-patient hospitalizations (p<0.0001 for both). Overall 6 month health care costs were $1,948 lower in individuals who received phamacogenomic testing via the Genecept Assay than controls. The number of psychotropic drugs prescribed did not differ between the groups. The authors concluded that this savings was clinically meaningful, and that pharmacogenetic testing represents a promising strategy to reduce costs and utilization among patients with mood disorders and anxiety disorders.

Perlis R et al. Pharmacogenetic testing among patients with mood and anxiety disorders is associated with decreased utilization and cost: A propensity-score matched study. Depression and Anxiety, 2018.

Pharmacogenomics and Psychiatry Review

This paper, intended for nurses involved in the care of mental health patients, reviews the emerging field of psychiatric pharmacogenomics, and how tests such as the Genecept Assay can be used to tailor pharmacologic approaches to individual patients. It is well known that many patients do not respond to initial pharmacologic therapy of psychiatric illness such as major depressive disorder (MDD). The role of specific genes associated with symptomatology, drug pharmacokinetics (metabolism of the compound), treatment response, and tolerability is described.

Amato RJ et al. Pharmacogenomics and Psychiatric Clinical Care. J Psychosoc Nurs Ment Health Serv 2018 56(1):22-1313.

Clinical Utility of Pharmacogenetics-guided Treatment of Depression and Anxiety

This study was a follow up analysis of the open-label study (Brennan 2015) referenced above. In this analysis the authors retrospectively looked at a subset of participants with variants of SLC6A4 (the serotonin transporter gene) and MTHFR (encoding methylenetetrahydrofolate reductase). Individuals with these variants whose subsequent treatment was consistent with the assay-guided treatment per the Genecept Assay tended to fare better on several self-reported outcomes than those individuals whose subsequent treatment was discordant with the assay. Specifically, individuals with SLC6A4 variants and assay-guided treatment reported significantly better quality of life outcomes.

Boland, J.R et al. Clinical utility of pharmacogenetics-guided treatment of depression and Anxiety. Personalized Medicine in Psychiatry (2017).

An Open Label Study of the Genecept Assay

This was a naturalistic, un-blinded, prospective analysis of psychiatric patients and clinicians who utilized the commercially available Genecept Assay. Results demonstrated a substantial proportion of individuals receiving pharmacogenetic testing showed clinically significant improvements on multiple measures of symptoms, adverse effects, and quality of life, over 3 months. When comparing response rates of patients receiving pharmacogenetic testing to the STAR*D trial, we found response rates for patients who use genetic testing far exceed the STAR*D reported response rates at all treatment levels. These data demonstrate that the incorporation of pharmacogenetic information into the treatment of patients with mood disorders and anxiety disorders produces benefits in depression and anxiety symptoms, side effects, and overall functioning.

Brennan FX et al. A Naturalistic Study of the Effectiveness of Pharmacogenetic Testing to Guide Treatment in Psychiatric Patients with Mood and Anxiety Disorders. Primary Care Companion CNS Disorders. 2015;17(2).

An Analysis of Health Claims Data and Cost Savings Associated with the Genecept Assay®

This large retrospective study utilized medical claims databases of U.S. patients covered by commercial health insurance, Medicare and Medicaid. Patients with a psychiatric diagnosis, treatment, and use of the Genecept Assay® were identified and compared with age and disease severity-matched controls that had a psychiatric diagnosis and treatment, but no use of the Assay. Patients using the Genecept Assay® showed a statistically significant increase in adherence to medication compared with untested controls, of 6.0%. Overall costs (cost of drugs plus outpatient practitioner medical activity) were significantly lower in those with Genecept Assay® guided treatment. Over a 4-month follow-up period, those with Genecept Assay® guided treatment demonstrated a relative cost savings of 9.5%, or $562 in total savings.

Fagerness J et al. Pharmacogenetic-Guided Psychiatric Intervention Associated With Increased Adherence and Cost Savings. American Journal of Managed Care. 2014;20(5):e146-e156.

Our clinical research and development team has chosen to include a comprehensive group of key genes to make up the Genecept Assay. These genes were selected based on hundreds of studies showing that variations in these genes can inform treatment decisions in psychiatry. For a summary of the peer reviewed, published literature supporting the inclusion of these genes in our test, and also cited in every patient report, please request our full Literature Summary from our Customer Service team.

The Genecept Assay® is a remarkable technologic advancement that has significantly improved our capabilities to optimize patient outcomes. We include the test as a part of each new patient evaluation, and have performed the assay on hundreds of patients in the past two years. We have learned there is a high level of patient endorsement of the test primarily because of their enhanced understanding of how medication works to help them feel better.

Bruce A. KehrMD, www.potomacpsychiatry.com