Randox has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for marketing its newest clinical drug testing panel. Available on the Evidence MultiSTAT, the fully automated multi-analyte analyser is powered by patented Biochip Technology.
Developed to offer accuracy in results, the solution is cost-effective and offers easy-to-use testing for efficient drug screening with an extensive cross-reactivity profile, reducing the negative impact on patient care.
The advanced rapid testing panel provides simultaneous detection of 15 drugs of abuse from urine in 21 minutes. With a simple three-step testing process, pre-filled reagent cartridges and results with very high accuracy comparable to confirmatory methods, the Evidence MultiSTAT gives clinicians and healthcare systems the quality they require to better patient clinical pathways.
As leaders in toxicology testing, Randox provides the detection of common and novel drug classes with the most extensive test menus available covering analytes such as fentanyl and 6-MAM. This breadth of capability supports efforts to address illicit drug use and excessive use of prescription medicine.
Although overdose fatalities were reported to have declined by nearly 27% in 2024, many individuals first encountered opioids through legitimate prescriptions. Over time, however, a significant shift has occurred toward illicit substances including heroin and highly potent synthetic opioids like fentanyl, which continue to be the primary contributors to overdose cases today.
David Ferguson, Chief Operating Officer commented: “Trusted across multiple industries, with widespread adoption and notable placements benefiting forensic toxicology, our latest panel broadens access to drug testing across a wide range of clinical and critical care environments, including emergency departments, hospital laboratories, pain management services, behavioural and psychiatric centres, and the criminal justice system to reduce the negative impact on patient care.”
