The Need for Vigilance in the Marketing of Genomic Tests in Psychiatry

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Recently, several for-profit companies have been developing and marketing genetic tests to psychiatrists, yet the clinical utility of these is not always clear, posing several concerns. Important genomic research is continuing, and genomic tests potentially can help with both the diagnosis and treatment of many patients. Yet it is important that clinicians be aware of potential limitations of tests that may be marketed to them.Different types of genomic tests are becoming available—from chromosome microarrays and single gene tests, assessing particular polymorphisms, to whole genome and whole exome sequencing. Research has sought to identify genetic markers associated with both various diagnoses and likelihoods of effectiveness and serious side effects of medications. Chromosome microarrays have identified markers associated with DiGeorge syndrome and schizophrenia, and deletions and duplications associated with approximately 1% of autism (Betancur, 2011). Over time, these and other tests can potentially be useful for a small group of psychiatric patients. Some markers, such as the DRD2 gene, which codes for the dopamine D2 receptor, affects antipsychotic medication efficacy. Yet though a particular variant has been found to lower drug response substantially, the sensitivity and specificity of this array are insufficient for clinical use (Zhang et al., 2010; Serretti et al., 2007).In general, the development of psychiatric tests in psychiatry has faced several limitations. Although the Clinical Laboratory Improvement Amendments Act (CLIA, 2015) focuses on ensuring quality control in laboratories, the Federal Drug Administration (FDA, 2015) only approves tests that have proven sufficient clinical utility. To date, only one psychiatric genetic test has received such approval—AmpliChip CYP450 Test (F. Hoffmann-La Roche Ltd, 2015) which assesses alleles of the CYP2D6 and CYPZC19 genes—though the FDA did not approve any specific clinical claims for it, and evidence that the test has clinical benefit is limited (Chau and Thomas, 2015).Laboratories can also develop and market tests directly to clinicians, even if these assays do not have FDA approval or any demonstrated clinical utility. The policy that permits marketing of such tests has raised controversy, in part because federal agencies do not ordinarily undertake post-marketing surveillance of these tests (Malhotra et al., 2012).In assessing genetic tests, the CDC’s Office of Public Health Genomics has supported the Evaluation of Genomic Applications in Practice and Prevention (EGAPP, 2014), based on the ACCE Model—the acronym based on four components of analytic validity, clinical validity, clinical utility, and associated ethical, legal, and social implications. EGAPP has listed recommendations concerning several diseases, of which only one is psychiatric—depression. Regarding adult testing for cytochrome P450 polymorphisms for depression, EGAPP concludes, “insufficient evidence to recommend for or against use, but use discouraged pending further research (EGAPP, 2014)”.Not only polygenetic influences but life circumstances and interpersonal and environmental interactions can shape many mental health conditions. Several tests are now being marketed to psychiatrists, based on reports of genetic markers found to be associated in various samples of patients with a range of psychiatric conditions. But the replicability and clinical utility of these have been limited (Burmeister et al., 2008). Nonetheless, Assurex Health, for instance, markets GeneSightRx ADHD and other tests (, 2012). Genomind sells the “Genecept Assay” to understand “genetic and biological markers that best inform responses to different psychiatric treatments (, 2015).” Proove Biosciences markets a test to determine the risk of abuse of narcotic pain killers, and another test purports to predict patients’ perception of pain (, 2015). Sundance Diagnostics plans to market a genetic test that predicts suicidality (PR Newswire, 2013).

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