This is the current release of the guideline.

Summary of Recommendation

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to support a recommendation for or against use of cytochrome P450 (CYP450) testing in adults beginning selective serotonin reuptake inhibitor (SSRI) treatment for non-psychotic depression. In the absence of supporting evidence, and with consideration of other contextual issues, EGAPP discourages use of CYP450 testing for patients beginning SSRI treatment until further clinical trials are completed.

Contextual Issues Important to the Recommendation

There is insufficient evidence on clinical validity and utility to support a recommendation for or against use of CYP450 testing in adults beginning SSRI treatment for non-psychotic depression. Thus, additional contextual issues were taken into account in the final EGAPP recommendation statement. Contextual factors could be considered to suggest potential benefits and harms of CYP450 testing, but there is little direct evidence of many of these factors.

Contextual factors that suggest potential benefits of CYP450 testing:

• Depression is a major health problem in the United States, with very large direct and indirect costs and impact on quality of life.
• SSRIs are the most commonly used approach to treating depression, and most experts consider SSRIs to be the treatment of choice.
• Empirical SSRI treatment for depression has varied effectiveness.
• Nonadherence to treatment is a major concern and many individuals drop out from treatment because of lack of effectiveness of SSRIs.

Contextual factors that suggest potential harms of CYP450 testing:

• Utilization of genetic testing for CYP450 polymorphisms and impact on physician decision-making with regard to use of SSRIs is not known.
• In the absence of evidence supporting clinical utility, widespread use of CYP450 genetic testing is potentially costly and may not lead to changes in treatment that improve patient outcomes.
• There have not been any published cost-effectiveness analyses. The costs of testing and follow-up are not known, although the test itself is relatively inexpensive.

None provided

The type of evidence supporting the recommendations is not specifically stated.

Not applicable: The guideline was not adapted from another source.

2007 Dec

Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group

This recommendation statement is a product of the independent, non-federal Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group.

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) initiative is a project developed by the National Office of Public Health Genomics (NOPHG) at the Centers for Disease Control and Prevention (CDC) to support a rigorous, evidence-based process for evaluating genetic tests and other genomic applications that are in transition from research to clinical and public health practice in the United States.

United States Government

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group

Group Members: Alfred O. Berg, MD, MPH (University of Washington) (Chair); Margaret Piper, PhD, MPH (Blue Cross/Blue Shield Association Technology Evaluation Center); Katrina Armstrong, MD, MSCE (University of Pennsylvania School of Medicine); Jeffrey Botkin, MD, MPH (University of Utah); Ned Calonge, MD, MPH (Colorado Department of Public Health and Environment); James Haddow, MD (Women and Infants' Hospital); Maxine Hayes, MD, MPH (Washington State Department of Health); Celia Kaye, MD, PhD (University of Colorado School of Medicine); Kathryn A. Phillips, PhD (University of California, San Francisco); Carolyn Sue Richards, PhD, FACMG (Oregon Health & Science University); Joan A. Scott, MS, CGC (Johns Hopkins University); Ora L. Strickland, PhD, DSc (Hon.), RN, FAAN (Emory University); Steven Teutsch, MD, MPH (Merck & Co.)

Margaret Piper is employed by the Blue Cross Blue Shield Association Technology Evaluation Center and has previously authored a technology assessment on cytochrome P450 pharmacogenomic testing. Steven Teutsch is an employee, option and stock holder in Merck & Co., Inc. All other authors have no conflicts of interest relevant to this manuscript.

This is the current release of the guideline.

None available

This NGC summary was completed by ECRI Institute on May 8, 2008. The information was verified by the guideline developer on June 6, 2008.

This NGC summary is based on the original guideline: Recommendations from the EGAPP Working Group: testing for cytochrome P450 polymorphisms in adults with nonpsychotic depression treated with selective serotonin reuptake inhibitors, Genet Med 2007:9(12):819-825. ©American College of Medical Genetics. Reprinted with permission of Lippincott Williams & Wilkins.