BREAKTHROUGH SCIENCE, LIFE-CHANGING RESULTS

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Brennan Study - An Open Label Study of the Genomind Genecept Assay

This was a naturalistic, un-blinded, prospective analysis of psychiatric patients and clinicians who utilized the commercially available Genomind 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. 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.

87% of patients showed mental health improvement.*

The Boland Study - 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 Genomind 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).

Amato Study 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 Genomind 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 are described.

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

Healthagen Study  - 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 and anxiety disorders following use of the Genomind Genecept Assay (cases, N=817) compared to similar patients whose treatment was not directed by pharmacogenomic 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, individuals who received testing with Genomind Assay (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 cases 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.

Fagerness Study - Analysis of Health Claims Data and Cost Savings Associated with the Genomind Assay (or Genecept)

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 Genomind 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 Genomind Genecept Assay showed a statistically significant increase in adherence to medication compared with untested controls by 6.0%. Overall costs (cost of drugs plus outpatient practitioner medical activity) were significantly lower in those with the Genomind Genecept Assay  guided treatment. Over a 4-month follow-up period, those with the Genomind 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.

McLean Study

This study is a six-month naturalistic prospective, randomized, open label, investigator-initiated[1] study of pharmacogenetic testing and clinical outcomes in inpatients across diagnoses, including treatment resistant depression (TRD) with or without post-traumatic stress disorder (PTSD), recruiting from the Short Term Unit at McLean Hospital (ClinicalTrials.gov Identifier: NCT03113890). The study originally planned to enroll 200 patients but was terminated at N=75 due to slow enrollment. Interim (3 month data)[2] were recently reported by the principle investigator. The complete protocol is included in Appendix 4. The primary objective was to determine if, by the 3-month follow-up, inpatient psychopharmacogenetic testing will reduce symptoms of depression and anxiety. A variety of psychometric instruments were administered at various time points, including baseline and 3 months.
The included data were collected between September 2017 and April 2019. Of the 75 patients enrolled in the study, 55 (73.3%) completed 3- month follow up surveys. Of the 36 assigned to the Treatment as Usual group (TAU) 28 (77.8%) completed the 3 month survey, and of the 39 assigned to the Assay Guided Treatment group (AGT) 27 (69%) completed the 3 month survey. For the interim analysis, only data collected at the 3 month post-discharge time point surveys were used.

McLean Study : Psychiatric Pharmacogenetic testing in an Adult Psychiatric Inpatient Population

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SOURCES:

[1] King CD et al. Psychiatric Pharmacogenetic Testing in an Adult Psychiatric Inpatient Population. Poster Presentation at US Psych Congress 2019

[2] Final 6 month data are not yet available, however the accrued 3 month data are final.