FDA faces backlash over approval of genetic test for opioid addiction risk
FDA faces backlash over approval of genetic test for opioid addiction risk
www.nbcnews.com FDA faces backlash over approval of genetic test for opioid addiction risk
In a letter to the agency, a group of experts called on the commissioner to revoke its approval, saying the test doesn't work.
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SOLVD Health said in its application that AvertD had demonstrated a sensitivity of about 82% and a specificity of about 79%.
Those numbers suggest that roughly 1 in 5 results would be false negatives and roughly 1 in 5 would be false positives.
That doesn't seem very good
Total error rate is about 2/5? That's barely better than a coin flip.
"Oh yes, I just got tested for my potential to become an opioid addict. Give me a second to flip a coin: heads I read the report, tails I toss it in the recycle bin."