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In a groundbreaking move, the FDA has granted approval for the inaugural test utilizing DNA analysis to evaluate the potential heightened risk of opioid use disorder in specific individuals. AutoGenomics Inc.’s AvertD test marks the pioneering step towards preemptive assessment before initial exposure to oral opioid pain medications.
Primarily designed for clinical evaluation, the AvertD test aims to identify individuals who may face an elevated risk of developing opioid use disorder. This test is intended for patients aged 18 and above, particularly those who are yet to experience oral opioid analgesics and are being considered for a 4-30 day prescription to address acute pain, including those scheduled for planned surgical procedures.
The prescription-based genetic laboratory test necessitates patient consent and is exclusively applicable to individuals who have not previously used oral opioid pain medications. By analyzing an individual’s genetic makeup, this test serves as a pre-emptive measure, guiding healthcare professionals in assessing the risk of opioid use disorder before commencing oral opioid pain medication treatment.
This approval signifies a pivotal development in mitigating the risk of opioid addiction, offering healthcare providers an advanced tool to identify potential susceptibility to opioid use disorder among certain patient demographics. This milestone underscores the FDA’s commitment to fostering innovative strategies in curbing the opioid crisis by integrating genetic-based assessments into the clinical evaluation process.
