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Pharmacogenetic Testing

Clinical Pearls FAQs

What do you think about the genetic testing being done for patients? How reliable is the information and how would you suggest we use this information?

Genetic testing provides information about how an individual metabolizes medication, but very limited information about how they might respond to a given medication. Medications are grouped as either “green,” “yellow,” or “red,” based on the degree of gene-drug interactions present [1]:

  • Green: none
  • Yellow: moderate number 
  • Red: significant number 

These color groups should  be interpreted with caution. It is important to look at the associated notes when genetic testing is conducted to determine how an individual may metabolize a given medication based on their enzymatic profile.

The two largest randomized control trials of pharmacogenetic testing in relation to psychopharmacology (GUIDED trial in 2019 and PRIME Care trial in 2022) evaluated a total of ~3,000 participants with Major Depressive Disorder and found no difference in symptom remission in patients whose medication choices were guided by genetic testing [3, 4]. Additionally, genetic testing can be cost-prohibitive, frequently costing patients with commercial insurance or a Medicare Advantage plan between $300–350.

The American Academy of Child and Adolescent Psychiatry released a policy statement on pharmacogenetic tests approved in 2020 as follows: 

Clinical Use of Pharmacogenetic Tests in Prescribing Psychotropic Medications for Children and Adolescents

Background

Several commercially available combinatorial pharmacogenomic tests are being marketed for psychiatric clinical practice. Commercial entities claim that the testing measures drug metabolism to guide medication choice and dosing to impact therapeutic response and side effects.

In October 2018, the Food and Drug Administration (FDA) issued a safety communication warning against the use of genetic tests with unapproved claims to predict medication response. The FDA stated that changing a patient’s medication regimen based on the results of a pharmacogenomic test leads to “inappropriate treatment decisions and potentially serious health consequences for the patient.”

Only a small fraction of the available commercial products have undergone randomized controlled trials in adults only.

Current studies are limited by:

  • Potential conflicts of interest
  • Small sample sizes
  • Short duration of follow-up
  • Lack of blinding
  • Lack of appropriate control groups

Additionally, numerous factors affect medication response unaccounted for by genetic variation. Genetic variations are managed clinically with slow and thoughtful medication management.

Furthermore, pharmacogenomic testing provides little meaningful information when two or more medications are used concurrently.

The American Academy of Child and Adolescent Psychiatry recommends:

  • Clinicians avoid using pharmacogenetic testing to select psychotropic medications in children and adolescents.
  • Future high-quality prospective studies to assess the clinical significance of pharmacodynamic and combinatorial pharmacogenomic testing in children and adolescents.

As it currently stands, the American Academy of Child and Adolescent Psychiatry (AACAP) and the American Academy of Family Physicians (AAFP) both do not recommend genetic testing as a primary guide for pharmacological treatment for mental health disorders [1,5].  

Abrams G, Malas N, Patel P. Pharmacogenetic Testing. Michigan Clinical Consultation & Care. November 4, 2025. https://mc3michigan.org/clinical-pearls-faqs-pharmacogenetic-testing/.

References:

  1. American Academy of Child and Adolescent Psychiatry. Pharmacogenetic Testing. Facts for Families. 2025. Available from: https://www.aacap.org/AACAP/Families_and_Youth/Facts_for_Families/FFF‑Guide/Pharmacogenetic_Testing‑128.aspx escholarship.org+8aacap.org+8aacap.org+8
  2. Bousman CA, Arandjelovic K, Mancuso SG, Eyre HA, Dunlop BW. Pharmacogenetic tests and depressive symptom remission: a meta-analysis of randomized controlled trials. Pharmacogenomics. 2019;20(1):37-47. doi:10.2217/pgs-2018-0142
  3. Greden JF, Parikh SV, Rothschild AJ, et al.,; GUIDED Study Investigators. 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 Apr;111:59–67. doi:10.1016/j.jpsychires.2019.01.003. PMID: 30677646 doctorsofnursingpractice.org+4PubMed+4NCBI+4
  4. Oslin DW, Wray LO, Chapman SR, et al.; PRIME Care Research Group. Effect of pharmacogenomic testing for drug‑gene interactions on medication selection and remission of symptoms in major depressive disorder: the PRIME Care randomized clinical trial. JAMA. 2022 Jan 11;328(2):151–61. doi:10.1001/jama.2022.8523. PMID: ? doctorsofnursingpractice.org+1Physician’s Weekly+1
  5. Samsa GP, Maise EA. GeneSight Psychotropic genetic testing panel. Am Fam Physician. 2021 Jul 1;104(1):89–96. Available from: https://www.aafp.org/pubs/afp/issues/2021/0700/p89.html ScienceDirect+3AAFP+3AAFP+3