FDA OKs test to spot patients at risk of opioid use disorder
A test that can be given to patients before they are prescribed a course of opioid analgesics to check whether they are at risk of becoming dependent on the drugs has been approved by the FDA.
AutoGenomics’ AvertD test – the first of its kind to be licensed in the US – uses DNA analysis to see if a patient has a combination of genetic variants that may be associated with an elevated risk of developing opioid use disorder (OUD).
Its approval comes as the US remains in the grip of an opioid epidemic, with tens of thousands of lives being claimed every year as a result of opioid overdosing, although, there had been signs of a slowdown in deaths in 2022 and 2023 after rapid increases in the years leading up to 2021.
It is not uncommon for OUD to find its origins in a short-term prescription for acute pain, with up to 13% of opioid prescriptions for less than 30 days leading to chronic opioid use, and 2023 provided a high-profile example.
The actor Matthew Perry – best known for his role as Chandler Bing in the sitcom Friends – struggled with addiction for years, but said it started when he was prescribed Vicodin for pain after a jet ski accident. He died this year at the age of 54, having bounced between relapse, rehab, and recovery since the late 1990s.
AvertD is the latest tool in the fight against OUD, and involves a simple cheek swab, administered by a healthcare provider, that should be carried out for adult patients being considered for a four- to 30-day prescription for the treatment of acute pain, before they are exposed to oral opioid painkillers.
The test should be an option only for patients who have not been prescribed oral opioids before, and as part of a clinical evaluation and risk assessment. That means a decision to prescribe should not be based on the genetic data alone, said the FDA, which awarded the test a breakthrough designation in 2018.
Rights to the test are held by SOLVD Health (formerly Prescient Medicine), which acquired AutoGenomics in 2019. It was also granted a CE mark by the European Commission in 2020, clearing the way for use in the EU.
Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health (CDRH), said the approval was for a new, modified version of a test that was previously reviewed at an advisory committee meeting last year.
“The advisory committee’s feedback helped inform the FDA’s evaluation of the test and today’s decision, including the conditions for approval,” said Shuren.
“The opioid crisis, one of the most profound public health issues facing the US, calls for innovative measures to prevent, diagnose, and treat opioid use disorder, including to assess the risk of developing the disorder.”
Other measures to tackle the epidemic implemented by the FDA include the approvals earlier this year of the first non-prescription naloxone nasal spray product used to treat overdose, along with the first generic naloxone nasal spray and the first nalmefene nasal spray.
