Good news! Why these unreasonable restrictions by the FDA!!!!
"The U.S. Food and Drug Administration (FDA) said on Tuesday it has approved the first test to assess if there is a risk of opioid use addiction in certain individuals.
The test, AvertD, is developed by privately held SOLVD Health. The FDA granted the approval to AutoGenomics, a unit that SOLVD acquired in 2019.
AvertD is intended to be used before the first use of oral opioid painkillers in those who are being considered for a 4 to 30 days prescription for the treatment of acute pain, such as in patients scheduled to undergo a planned surgical procedure. ..."
"Today, the U.S. Food and Drug Administration approved the first test that uses DNA in assessing whether certain individuals may have an elevated risk of developing opioid use disorder (OUD). ...
The AvertD test, a prescription-use only genetic laboratory test for patients 18 years and older, is to be used only with patients who consent to the test and have no prior use of oral opioid analgesics. The test is administered by a health care provider by swabbing the cheek of a patient to collect a DNA sample that will be used to determine if a patient has a combination of genetic variants that may be associated with an elevated risk of developing OUD. ... The test is not intended to be used in patients being treated for chronic pain. AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions. ..."
FDA Approves First Test to Help Identify Elevated Risk of Developing Opioid Use Disorder
AvertD (website is unfinished)
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