Genecept Assay

FOR CLINICIANS

The Genecept Assay® is a genetic test used to inform clinicians’ decision-making when prescribing medications and treatments for psychiatric conditions.

Genetic results provide one piece of evidence for the heterogeneity observed in medication response. They offer information about the likelihood that a patient will respond to a medication therapy and/or experience adverse events or drug interactions. Treatment decisions informed by these genetic results can offer a personalized treatment plan to objectively address presenting symptoms and side effects. The genes analyzed in the Genecept Assay are associated with a wide range of psychotropic medications and can help to inform treatment plans for depression, anxiety, obsessive-compulsive disorder (OCD), attention deficit hyperactivity disorder (ADHD), bipolar disorder, post traumatic stress disorder (PTSD), autism, schizophrenia, chronic pain and substance abuse.

This personalized, data-driven approach, which is pain-free and simple to perform, can reduce the time, expense and struggle of finding the right treatment by trial and error.

Genes Analyzed in the Genecept Assay®

The Genecept Assay includes 18 well-characterized, well-annotated genes, extensively supported in peer-reviewed publications to affect treatment for psychiatric conditions. It includes pharmacodynamic genes, which indicate the effect a drug has on the body and can inform drug candidate selection. It also includes pharmacokinetic genes, which indicate the effect the body has on the drug via metabolism and can inform drug dosage.

Sample Genecept Assay® Results Report

The Genecept Assay report is intended to aid clinicians in making personalized treatment decisions tailored to a patient’s genetic background and can help to inform psychiatric treatments that:

1. Are more likely to be effective.

2. Have lower risk for side effects and adverse events.

3. Are dosed appropriately.
Review a sample results report below, including the genetic results summary and the drug interaction summary.

Genetic Results Summary

The Genecept Assay results report includes a listing of all of the variations detected in the genes analyzed on the test. It also includes the therapeutic implications of each genetic result, potential gene-drug interactions, and the overall clinical impact of each variation detected.

Drug Interaction Summary

Each patient report includes a drug interaction summary. The drug interaction summary is a guide for clinicians to help determine which therapies may be most beneficial for a patient based on the Genecept Assay results. This summary table lists medications in alphabetical order by drug class, and indicates how they are metabolized.

Medications fall into three categories:

• Use as Directed: These therapies have no known gene-drug interactions to consider.

• Therapeutic Options: These therapies are an option for the patient based on one or more genetic variations.

• Use with Caution: These therapies may require a dose adjustment or have a higher risk of side effects or inefficacy.

Contact Primly Services for more details: 09082002476

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 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 and anxiety disorders.

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 and anxiety disorders produces benefits in depression and anxiety symptoms, side effects, and overall functioning.

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.

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

• GENOMIND
• Genecept Assay / For Clinicians