Diagnostic Tests

What Physicians Need to Know

GeneSight Psychotropic Genetic Testing for Psychiatric Medication Selection

 

Am Fam Physician. 2021 Jul ;104(1):89-90.

GeneSight Psychotropic is a pharmacogenomic test (multigene panel) that uses a proprietary algorithm to evaluate pharmacokinetic and pharmacodynamic relationships, resulting in drug recommendations or warnings for certain neuropsychiatric medications. Testing can potentially help guide efficient medication selection or dosing. GeneSight has not been submitted to the U.S. Food and Drug Administration (FDA) for approval.

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TestIndicationPopulationCost*

GeneSight Psychotropic

DNA genetic testing for drug response and therapeutic management of psychiatric medications

Patients of any age taking or expecting to take neuropsychiatric medications†

$1,569


*—Medicare payment rate as of September 2020.8

†—No peer-reviewed studies have examined medication or behavioral outcomes of GeneSight testing in children.

TestIndicationPopulationCost*

GeneSight Psychotropic

DNA genetic testing for drug response and therapeutic management of psychiatric medications

Patients of any age taking or expecting to take neuropsychiatric medications†

$1,569


*—Medicare payment rate as of September 2020.8

†—No peer-reviewed studies have examined medication or behavioral outcomes of GeneSight testing in children.

Accuracy

Evaluating a pharmacogenomic test involves analysis of molecular diagnostic test standards. Sensitivity and specificity metrics are not always clear because of the many different aspects of the test, such as enzyme activity, levels of medication in the blood, and metabolizer status. Although some of this information may be helpful in clinical decision-making, it is difficult to calculate accuracy using traditional dichotomous variables.

The GeneSight test currently analyzes 57 neuropsychiatric medications and 12 genes.1,2 The test has a precision of 100% in detecting the genes themselves.3

Test results are summarized in a pharmacogenomics report based on the genes of the patient and possible medication combinations. A color-coded category interpretation is given on the report: green (use as directed), yellow (moderate gene-drug interaction), or red (significant gene-drug interaction). Drugs in the yellow or red category are further labeled with up to nine clinical considerations:

  • Serum level may be too high, lower doses may be required

  • Serum level may be too low, higher doses may be required

  • Difficult to predict dose adjustments because of conflicting variations in metabolism

  • Genotype may impact drug mechanism of action and result in reduced effectiveness

  • Use of this drug may increase risk of adverse effects

  • Serum level may be too low in smokers (only cigarettes)

  • FDA label identifies a potential gene-drug interaction for this medication

  • Per FDA label, this medication is contraindicated for this genotype

  • This medication does not have identified or clinically proven genetic markers that allow it to be categorized

Benefit

GeneSight testing can be performed

Address correspondence to Natasha Pyzocha, DO, at natashapyzocha@gmail.com. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.

References

show all references

1. U.S. Food and Drug Administration. Nucleic acid based tests. Accessed February 8, 2021. https://www.fda.gov/medical-devices/vitro-diagnostics/nucleic-acid-based-tests...

2. GeneSight. The GeneSight Psychotropic combinatorial algorithm. Accessed February 8, 2021. https://genesight.com/white-papers/the-genesight-psychotropic-combinatorial-algorithm/

3. Jablonski MR, King N, Wang Y, et al. Analytical validation of a psychiatric pharmacogenomic test. Per Med. 2018;15(3):189–197.

4. Greden JF, Parikh SV, Rothschild AJ, et al. Impact of pharmacogenomics on clinical outcomes in major depressive disorder in the GUIDED trial: a large, patient- and rater-blinded, randomized, controlled study. J Psychiatr Res. 2019;111:59–67.

5. Hicks JK, Bishop JR, Gammal RS, et al. A call for clear and consistent communications regarding the role of pharmacogenetics in antidepressant pharmacotherapy. Clin Pharmacol Ther. 2020;107(1):50–52.

6. Hicks JK, Bishop JR, Sangkuhl K, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guideline for CYP2D6 and CYP2C19 genotypes and dosing of selective serotonin reuptake inhibitors. Clin Pharmacol Ther. 2015;98(2):127–134.

7. Bousman CA, Bengesser SA, Aitchison KJ, et al. Review and consensus on pharmacogenomic testing in psychiatry. Pharmacopsychiatry. 2021;54(1):5–17.

8. Ray T. Medicare lab payment analysis raises questions about pricing transparency. Modern Healthcare. Accessed March 1, 2021. https://www.modernhealthcare.com/healthcare-economics/medicare-lab-payment-analysis-raises-questions-about-pricing-transparency

9. GeneSight. GeneSight cost. Accessed February 8, 2021. https://genesight.com/cost/

10. Centers for Medicare and Medicaid Services. Clinical laboratory fee schedule. Accessed February 8, 2021. https://go.cms.gov/3by9TQX

11. Li KX, Loshak H. Pharmacogenomic testing in depression: a review of clinical effectiveness, cost-effectiveness, and guidelines. January 31, 2020. Accessed February 8, 2021. https://www.ncbi.nlm.nih.gov/books/NBK562923/

12. de Leon J, Spina E. What is needed to incorporate clinical pharmacogenetic tests into the practice of psychopharmacotherapy? Expert Rev Clin Pharmacol. 2016;9(3):351–354.

This series is coordinated by Kenny Lin, MD, MPH, deputy editor.

A collection of Diagnostic Tests published in AFP is available at https://www.aafp.org/afp/diagnostic.

 

 

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