Intelligent Bio Solutions Advances Fingerprint Drug Screening Tech Towards FDA Approval
核心洞察
Intelligent Bio Solutions reports positive pharmacokinetic study results, indicating fingerprint sweat accurately reflects codeine levels in blood and saliva.
The company plans to submit the PK study data as part of its 510(k) submission to the FDA by the end of the year.
The fingerprint drug screening technology is slated for potential launch in the US in 2025, targeting applications in law enforcement and forensics.
Intelligent Bio Solutions is moving closer to securing FDA approval for its innovative fingerprint drug screening technology, following the release of what the company describes as "strong initial results" from a pharmacokinetic (PK) study. The US-based company anticipates launching the technology in the US in 2025, with potential applications spanning law enforcement, forensics, and various safety-critical industries.
The PK study data demonstrated a close correlation between drug levels detected in fingerprint sweat and those found in blood and saliva. According to the company, fingerprint sweat provides a reliable sample matrix for drug detection, with quantitative PK data closely aligned to blood based on statistical comparisons made at a 95% confidence level.
Harry Simeonidis, president and CEO of Intelligent Bio Solutions, stated, "The close correlation of PK parameters in fingerprint sweat and blood highlights its robustness as a sampling approach...our clinical study further reinforces these findings." The company plans to include the PK study data in its 510(k) submission to the FDA, expected by the end of the year.
The PK study involved 39 healthy participants who were administered codeine under medical supervision. Researchers then compared opiate levels detected in fingerprint sweat with those found in blood, oral fluid, and urine samples. Fingerprint sweat samples were analyzed using validated, traceable liquid chromatography/tandem mass spectrometry.
Simeonidis added, "We are very pleased with the PK study results. This data highlights the potential for our technology to achieve widespread adoption in safety-critical industries and beyond, marking a significant achievement as we advance toward FDA clearance in the US."
Other companies are also exploring sweat-based drug detection technologies. Epicore, for example, has partnered with the US Anti-Doping Agency (USADA) to develop a wearable sweat-collection device, the Discovery Patch, for doping control.