Genomind Expands Mental Health Genetic Testing

Genomind is expanding its mental health genetic testing services with the addition of Genomind Professional PGx Express, which provides a focused report and set of services to enhance the preexisting mental health genetic test.

The new expansion will launch August 10.¹

Genomind created the Professional PGx Express in repsonse to positive clinician feedback and increasing interest in the ways that genetic testing can be used to pinpoint mental health concerns and streamline treatment.

The test analyzed 24 genes associated with mental health, including pharmacodynamic and pharmacokinetic genes. Pharmacodynamic genes can be evaluated to assess the effect a drug has on the body, while pharmacokinetic genes can show how the drug is metabolized.

After the genetic testing itself, the physician is provided with a comprehensive report so that they can quickly understand and streamline treatment to the patient's needs.

"Our understanding of how genetics impacts disease and wellness continues to grow exponentially, particularly in the mental health space, which is ten years behind other diseases, such as cancer," said Shawn Patrick O'Brien, chief executive officer at Genomind, Inc., in a statement.

The FDA has been monitoring pharmacogenetic testing and its increasing use in the mental health landscape, but they've also warned against some tests which have claimed to predict patients' responses to various medications. Some software programs have also made claims to interpret genetic information in order to predict reactions to medications, but the FDA emphasized that clinical evidence is not currently available for the genetic tests or software programs, and those claims are therefore not supported.

The FDA urged genetic test manufacturers to ensure that their labeling is clear and accurate and that their test report and any labeling support an FDA-approved intended use of the medication discussed.²

The new Genomind Professional PGx Express is designed to comply with those FDA warnings, as well as to provide context on genetic profiles and how they can impact a patient's treatment.

References

• 1. Ashley A. Genomind Expands Mental Health Genetic Testing Services with New Genomind Professional PGx Express. Genomind. https://genomind.com/news/genomind-expands-mental-health-genetic-testing-services-with-new-genomind-professional-pgx-express/. Published August 5, 2019. Accessed August 12, 2019.
• 2. Center for Devices and Radiological Health. Genetic Tests with Unapproved Claims to Predict Patient Response. U.S. Food and Drug Administration. https://www.fda.gov/medical-devices/safety-communications/fda-warns-against-use-many-genetic-tests-unapproved-claims-predict-patient-response-specific. Published April 4, 2019. Accessed August 12, 2019