Labcorp Launches First FDA-Cleared Rapid Fentanyl Test for U.S. Emergency Care
Event summary
- Labcorp launched the first FDA-cleared rapid fentanyl test manufactured in the U.S., delivering results in 10 minutes.
- The test detects norfentanyl, the primary fentanyl metabolite, with a 48-hour detection window.
- Labcorp data shows 4% of pre-employment screenings and 10% of opioid disorder treatments tested positive for fentanyl between 2024-2025.
- The test is available through Labcorp Point of Care, formerly MEDTOX Diagnostics, with a rebranding transition throughout 2026.
The big picture
Labcorp's rapid fentanyl test addresses the urgent need for quick, reliable screening in emergency care settings amid rising synthetic opioid use. The FDA clearance positions Labcorp as a leader in point-of-care diagnostics, leveraging its acquisition of MEDTOX Diagnostics to expand its portfolio. The test's success could influence broader adoption of rapid diagnostic tools in acute care environments.
What we're watching
- Market Adoption
- The pace at which emergency departments and hospitals adopt the rapid fentanyl test will determine its commercial success.
- Regulatory Compliance
- Whether Labcorp can maintain FDA clearance while expanding the test's applications beyond preliminary screening.
- Competitive Dynamics
- How competitors respond to Labcorp's FDA-cleared test, potentially leading to new rapid diagnostic tools in the fentanyl detection space.
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