On April 25th 2018 the American Psychiatric Association published the following criticism of genomic testing emphasizing their skepticism towards psychiatrists who are using genetic testing to make informed decisions about diagnosis and treatment. An abstract of their statement reads:

 

 

 

Evidence Does Not Support Commercial Rush Of DNA Tests Designed To Inform Decisions Regarding Patients’ Psychiatric Medications, Review Indicates.

STAT (9/28, Robbins) reported that “several dozen companies” are now “probing patients’ DNA in search of insights to help inform decisions about what psychiatry medications patients should take,” and are even “touting applications for depression, bipolar disorder, attention deficit hyperactivity disorder, and post-traumatic stress disorder.” Now, “some top psychiatrists say the evidence doesn’t support the commercial rush.” In fact, in a review published online April 25 in the American Journal of Psychiatry, “a task force of the American Psychiatric Association’s research council concluded that such genetic testing is not ready for prime time in their field.” The members of the task force wrote, “Although some of the preliminary published data sound promising…there is insufficient evidence to support widespread use of combinatorial pharmacogenetic decision support tools at this point in time.”

To read their full statement please visit this link.

Genomind and Genesight – two separate entities that are both equally dedicated to the science behind psychotropic testing put forward responses to the criticisms made by the American Psychiatric Association.

Genesight: An in-depth look at the psychotropic testing process.

They thoroughly answer common questions about genetic testing:

How are molecular diagnostic tests evaluated?

Molecular diagnostic testing and pharmacogenomic testing differ in their objectives and possible testing outcomes. Diagnostic testing detects whether an individual is affected with a specific disease or not, and the testing outcome is generally one of two outcomes: positive or negative. In diagnostic testing, sensitivity is the ability of a test to correctly identify a patient who has a disease as having the disease (true positive). Specificity is the ability of a test to correctly identify a healthy individual as not having the disease (true negative). Both sensitivity and specificity have only two possible outcomes: for sensitivity, consider that a diagnostic test may either result in a true positive or a false negative; for specificity, a diagnostic test may either be a false positive or a true negative.

Why is it necessary to evaluate pharmacogenomic tests differently than diagnostic tests?

Psychiatric pharmacogenomics does not have an individual genetic marker or causative gene like is often typical in molecular diagnostic testing; rather, medication response is multifactorial, relying on the interaction of many genes, as well as environmental factors. For this reason, the GeneSight test’s proprietary CPGx® technology takes into account all relevant genes known to be associated with medication response. Consequently, the potential measurements of sensitivity and specificity shift from the association of a genetic marker with response to the association of the GeneSight algorithm with response. Instead of diagnosing the bimodal presence or absence of a disease state, the GeneSight test predicts patient response to medications using a three category system (green, yellow, red), which correlates with the predicted amount of gene-drug interaction for the patient (none, moderate, and significant, respectively). Unlike a two-category system, a three-category system does not lend itself to sensitivity and specificity measurements.

Additionally, a complexity arises in the fact that many patients taking psychiatric medications are not taking just one. Polypharmacy further complicates the multifactorial nature of medication response, since medications may compete for the same target or induce/inhibit relevant metabolizing enzymes. In the context of the GeneSight test, this means patients may be taking medications from each of their green, yellow, and red categories. Consequently, calculating the sensitivity and specificity for each individual medication loses real world application. In the clinical studies that validate the GeneSight test, patients are entered into analyses based on their total medication regiment. This is accomplished by putting a patient in their “worst” medication category. For example, a patient taking one green and one red category medication is entered into the analysis as a red category patient. This approach empowers a more comprehensive analysis of a patient’s overall medication response, rather than analyzing a patient’s response to each medication individually, since it is nearly impossible to determine which medication correlates to specific aspects of a patient’s response.

To read their description of how genetic tests are evaluated please visit this link.

Genomind: Genetic Testing Can Reduce Healthcare Costs for the End User

Genomind, raised a further interesting point how genetic testing can help decrease costs for the end user. They say:

“Pharmacogenetic testing represents a promising strategy to reduce the amount of medication trial and error and associated complications for patients with mood and anxiety disorders,” said Roy Perlis, M.D., Professor of Psychiatry at Harvard Medical School, a Genomind scientific advisor and one of the paper’s authors.

Genomind’s Genecept Assay®, a pharmacogenetic test, requires only a small sample of saliva, collected by a clinician from swabbing the inside of the patient’s cheek with a cotton swab. The test looks at key genes in a patient’s DNA that can affect the patient’s response to medication. In the study based on claims data, 817 Aetna members with mood and anxiety disorders who underwent testing with the Genecept Assay (cases) were matched with 2,745 similar Aetna members who did not undergo testing (controls) on a variety of dimensions, such as diagnosis, duration of illness, comorbidities, number of prior treatment failures, age, gender and socioeconomic status.

Those who had genetic testing experienced 40 percent fewer emergency room visits and 58 percent fewer inpatient hospitalizations than individuals in the control group who did not receive genetic testing to help guide their treatment (p<0.0001 for both). That is, testing was associated with significantly less utilization of emergency rooms and inpatient visits during the following six-month period. The two groups did not differ significantly in number of psychotropic medications prescribed or mood disorder–related hospitalizations.

PASWFL Uses Genetic Testing

As part of our diagnostic and evaluative processes PASWFL is a firm believer in the science behind DNA. PASWFL finds that using genetic testing can save time and money for the end user and leads to a more direct treatment plan. PASWFL uses genetic testing to provide outstanding psychiatric care using a combination of ketamine treatment, theta burst stimulation and transcranial magnetic stimulation. We believe genetic testing can help us perfect our already customized treatment plans for our patients. Read more about our genetic testing and all our services on our website.