FDA approves first ever DNA test to help screen for risk of opioid use disorder

The first-ever DNA test to help determine whether a person is at high risk of developing opioid use disorder was approved this week by the Food and Drug Administration (FDA).

The FDA has approved the AutoGenomics AvertD test for use in adults who are considering treating acute pain with short-term prescriptions for opioid analgesics, such as after planned surgery.

This test is not intended for use by patients receiving treatment for chronic pain. The FDA said the information obtained from the test could help patients make better-informed decisions. The agency emphasized that this information should be used as part of a complete clinical evaluation and risk assessment, and should not be used alone to determine treatment.

This test, performed by a health care provider, takes a DNA sample from a patient's cheek swab to determine whether the patient has a combination of genetic mutations that may be associated with an increased risk of developing opioid use disorder. used to judge.

“The opioid crisis, one of the most serious public health issues facing the United States, requires innovative measures to prevent, diagnose, and treat opioid use disorder, including assessing the risk of developing opioid use disorder. “We need it,” FDA Commissioner Jeff Shuren said. The Center for Equipment and Radiological Health said in a statement.

“This approval represents another step forward in FDA's efforts to prevent new infectious disease outbreaks.” [opioid use disorder], to help treat people with this disorder and reduce misuse of opioid painkillers. ”

The FDA's approval comes after the agency's advisory committee last year overwhelmingly rejected an earlier version of the trial based on safety and efficacy data.

Shuren said the agency worked with manufacturers as they revised their tests and then submitted another application under the new test's more stringent approval pathway.

As part of the approval, the manufacturer will provide training to healthcare providers to ensure appropriate use of the test, conduct extensive post-marketing studies to evaluate the device's performance in patients, and regularly monitor progress. A report must be submitted to FDA.

The main risk associated with AvertD, as with any diagnostic test, is false results. The FDA said false negatives can provide a “false sense of security” for people at high risk for opioid use disorder, while false positives can lead to inappropriate pain management treatment.