On November 8, 2024, Clongene independently developed the Fentanyl Rapid Test Kit, which received FDA 510(k) approval and can meet the testing needs of home and professional institutions. The product is set to be one of the forces supporting the drug abuse campaign in the United States.  

Fentanyl is a potent synthetic opioid that has caused a severe public health crisis due to its abuse in the United States. Since 2000, more than one million people have died from drug overdoses in the U.S., with the majority of these deaths being related to opioids. In 2022, drug overdose-related deaths across the country reached 109,000, with over two-thirds involving fentanyl.

The U.S. government, in response to the crisis, has intensified its control over the abuse of fentanyl. In August 2022, the United States planned to allocate more than $450 million to combat the drug abuse situation, primarily involving fentanyl. Against this backdrop, rapid detection technology for fentanyl has become essential, aiding regulatory agencies in strengthening prevention, harm reduction, treatment, and support for recovery services, as well as combating illegal drug smuggling.

The CLUNGENE Fentanyl Rapid Test Kit, which recently obtained the FDA 510(k) market clearance, is capable of qualitatively detecting the presence of fentanyl in human urine with a detection threshold of 1ng/mL, showing extremely high sensitivity. The kit is user-friendly, provides results within 5 minutes, and meets the requirements for both home and professional use.

The recent FDA 510(k) clearance of CLUNGENE Fentanyl Rapid Test Kit marks a significant expansion into the North American market for home-use products, enriching the self-testing offerings. Building on this momentum, Clongene is committed to increasing R&D investments and continuously innovating to diversify our product range in the drug-testing field to contribute to global anti-drug efforts.