GeneSight Medical Testing

Finding the right treatment:
“Personalized medicine” is a somewhat new medical model that uses patient specific information, such as a patient’s own genetic makeup (or genotype) in order to enable an individualized approach to treatment.

There are several commercially available tests to determine a patient’s unique DNA profile. This information can be used to guide treatment decisions.

Most of the available tests provide information about how the body works to metabolize a medication (pharmacokinetic interactions). An abnormality may predict increased side effects or suggest higher-than-usual doses will be required to achieve the desired effect. There are also markers that predict what a medication will do to the person’s body based on genetically coded proteins and receptors (pharmacodynamic interactions).

Pharmacogenomics versus pharmacogenetics:
The term pharmacogenomics is often used interchangeably with pharmacogenetics. Although both terms relate to drug response based on genetic influences, pharmacogenetics focuses on single drug-gene interactions, while pharmacogenomics encompasses a more genome-wide association approach. 

While other factors may be involved, a person’s DNA profile remains the same throughout their lifetime. Therefore, once pharmacogenomic testing has been completed, information regarding tolerability and response to medications and treatments that haven’t even been developed yet will be possible.

What to expect:
At your appointment, Dr. Miller will take a brief history and determine if pharmacogenomic testing is indicated. A sample will be collected, usually via a check swab or from saliva. Once the results are available, our office will forward a copy to the patient for their records and discuss the results, either in person or over the phone.

A fee is payable at the time of service. This is expressly for testing and does not establish a patient-doctor relationship.

There will be a separate fee for laboratory services. This may or may not be covered by insurance. We suggest that patients contact the billing department of the company running the test prior to ordering.

GeneSight Clinical Studies

• GUIDED (Genomics Used to Improve DEpression Decisions) Clinical Study
  • Study Design: This was an 8 week, blinded, multi-center, randomized controlled trial of 1,167 subjects with major depressive disorder from 20 academic sites and 40 community sites.  The trial was unblinded after the 8 week check-in, and the subjects were followed out to 24 weeks.  The study assessed the impact of the GeneSight Psychotropic test on psychiatric treatment response compared to treatment as usual (TAU).  The raters used the Hamilton Rating Scale for Depression (HAM-D17), and the subjects had to have a minimum score of 14 in order to be eligible for the study.
• La Crosse Clinical Study
  • Study Design: This was a prospective, open-label study of 165 subjects with a primary diagnosis of major depressive disorder.  Subjects had to have a minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17).  Subjects were also assessed using the Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C16) and the Patient Health Questionnaire (PHQ-9). The study compared patient outcomes between GeneSight group and treatment as usual group (TAU) at week 8.
    
• Pine Rest Clinical Study
  • Study Design: This was a blinded, randomized controlled trial of 49 subjects with a primary diagnosis of major depressive disorder.  Subjects had to have a minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17).  It compared patient outcomes between the GeneSight group and the treatment as usual group (TAU) at week 10.
    
• Hamm Clinical Study
  • Study Design: This was a prospective, open-label study of 44 subjects with a primary diagnosis of major depressive disorder.  Subjects had to have a minimum score of 14 on the 17-item Hamilton Rating Scale for Depression (HAM-D17).  Subjects were also assessed using the Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C16). The study compared patient outcomes between the GeneSight group and the treatment as usual group at week 8.
    
• Medco Economic Study
  • 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 (medications with no or moderate gene-drug interactions) or non-congruent (medications with significant gene-drug interactions) with each individual’s GeneSight results.
    
• Union Health Service Economic Study
  • Study Design: The effect on healthcare utilization when prescribed a medication with significant gene-drug interactions was evaluated in a 1-year, blinded, retrospective study of 96 subjects with a DSM-IV-TR diagnosis of depression or anxiety disorder.
    
• Impact Clinical Study
  • Study Design: This was an 8-12 week, prospective, naturalistic study that assessed 1,871 patients who had moderate-to-severe depression and were treated by primary care providers or psychiatrists. The study assessed the impact of the GeneSight Psychotropic test on patient outcomes using the Beck Depression Inventory. Patients had to have a BDI score ≥20 to be included in the study.