FDA: Unapproved Genetic Tests Claim to Predict Drug Response

The Food and Drug Administration (FDA) issued a warning to Inova Genomics Laboratory for the illegal marketing of pharmacogenetic tests for predicting medication response to antidepressants, opioids, cancer therapy, anesthesia, and diabetes treatments.

The warning letter describes how Inova’s MediMap tests are being falsely marketed to predict drug response to aid in making treatment decisions and avoid “trial-and-error prescribing.” In addition, the MediMap Baby test for newborns claims to predict response to 24 drugs to provide guidance in prescribing safer and more effective medications.

According to the FDA, no data are available to establish the validity of these tests for their intended uses. For some drugs, where proper usage can be guided by pharmacogenetic testing, the FDA reviews data showing a relationship between the drug’s effects and genetic variants and includes the information in the drug labeling. Inappropriate selection or modification of treatment based on unapproved genetic tests may cause potentially serious health issues for patients and worsening of the disease.

“We are issuing this warning letter as part of our ongoing efforts to protect the public from the significant risk these tests pose,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. “We are particularly concerned about pharmacogenetic tests that claim to predict patients’ responses to specific medications where such claims have not been established and are not described in the drug labeling and continue to warn patients and health care professionals that they should not rely on these tests for treatment decisions.”

In November 2018, the FDA issued a safety communication about pharmacogenetic tests that were being marketed to consumers that claimed to predict their response to certain medications.

For more information visit FDA.gov.

This article originally appeared on MPR