According to the article – The AvertD test is intended to be used before patients who are being considered for a 4- to 30-day prescription for acute pain (e.g., for a planned surgical procedure) are first exposed to oral opioids. Does this suggest that anyone taking opioids > 30 days should be diagnosed with SUD or OUD? After all, the DEA states that ALL OPIOIDS ARE HIGHLY ADDICTIVE! Is the FDA aligning with PROP and the opiophoic “experts” that created the 2016 & 2022 CDC opioid dosing guidelines?
First Test to Identify Opioid Addiction Risk Approved by FDA
Genetic test intended to be used before patients are exposed to oral opioids for acute pain
https://www.medpagetoday.com/neurology/opioids/107962
The FDA approved the first test that uses DNA to identify whether adults have an elevated risk of developing opioid use disorder (OUD), the agency said Tuesday.
The AvertD test is intended to be used before patients who are being considered for a 4- to 30-day prescription for acute pain (e.g., for a planned surgical procedure) are first exposed to oral opioids. It is not intended for patients being treated for chronic pain, the agency said.
“AvertD may help patients who are concerned about being treated with an opioid for acute pain make better informed decisions,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA granted approval of AvertD, a prescription-use-only genetic laboratory test, to AutoGenomics, a unit of SOLVD Health. In October 2022, an FDA advisory committee voted strongly against an earlier version of AvertD, with false-negative and false-positive test results being a primary concern.
The earlier AvertD version detected the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. At the advisory committee meeting, SOLVD presented results of an observational study that demonstrated a sensitivity of 82.76% and a specificity of 79.23% for detecting OUD.
Following the advisory committee meeting, the FDA worked with AutoGenomics as it revised its test. The company subsequently submitted a premarket approval application for the modified test.
The test involves swabbing a patient’s cheek to collect a DNA sample. As part of the approval order, AutoGenomics must provide training to healthcare providers to help ensure the test is being used appropriately. The company also must conduct a large post-marketing study to assess AvertD’s performance in patients and regularly report the study’s progress to the FDA.
The primary risks associated with AvertD are false-negative and false-positive results, the FDA noted. A false-negative result could lead to a false sense of security for a patient who has an increased risk of OUD; a false-positive result could lead to inadequate pain management.
“The risks of false-negative and false-positive results can be mitigated, in part, through accurate, transparent product labeling and a healthcare provider training program,” the FDA said. “It is critical that users of the test (healthcare providers and patients) understand how to interpret the test result and use it not in isolation, but as part of a comprehensive clinical evaluation and risk assessment.”
Filed under: General Problems
In my opinion, this is utterly despicable because it appears to be nothing more than yet another flawed way to “justify” the denial of pain relief to individuals who have a positive result. Are they going to run secondary testing to confirm that result? I doubt it. So how would anyone know if their test was a false positive? That aside, people who have a genetic predisposition to addiction are not guaranteed to develop addiction any more than a patient with a predisposition for certain cancers are guaranteed to develop those specific cancers. It may be worthwhile to monitor more closely if someone has a positive result, but seeing as how doctors do not initiate treatment for cancers that a patient is predisposed to prior to them developing those cancers, we shouldn’t treat people with a genetic predisposition to addiction any differently. I think this sets a dangerous precedent in which human beings are rated on whether they’re worthy of humane treatment based on factors well beyond their control. Much like farm animals sorted on market worthiness. This isn’t a “best moment” for humanity, and as we all can probably imagine, it will almost certainly be abused. This sends the message that certain people are not acceptable for adequate pain management and it will leave an indelible stain on their medical records which very well may cause them to be treated differently because of it. What a terrible thing to do in the name of “saving people”.
Amen,,,exactly!!!!maryw
Wow, so addiction ISN’T under the control of each individual? Wow. Guess my drug addict brother who got iver his addiction and never looked back was somehow special? He would say “nay.” Addiction isnt genetic, it’s behavioral.
Sooo now we have a ,”test” to determine who get tortures medically and who doesn’t??wow how humane of our federal government!!!!!!!!!!NOT,,,,!,,HOW MUCH IS KOLODNYS CRONIES PAYING OUR GOVERNMENT,,DOES ANYONE KNOW,,,PROP,,???,,, wow,,a test to justify torture in the
healthcare setting,,,,humanity
truly is in the dark ages,,were in trouble folks,,,,maryw
“Thought Crime”? Welcome to 1984.