Intelligent Bio Solutions plans to file for 510(k) clearance with the US FDA in Q4 this year. Image credit: PRESSLAB / Shutterstock.

US based company Intelligent Bio Solutions has released “strong initial results” from a pharmacokinetic (PK) study and is one step closer to getting its fingerprint drug screening technology approved in the US.

The data from the PK study showed that “fingerprint sweat mimics the rate and extent of codeine in blood and saliva.” Adding that fingerprint sweat provides a reliable sample matrix for drug detection, showing quantitative PK data closely aligned to blood, based on statistical comparisons made at the 95% confidence level.

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The company plans to submit the PK study data as part of the 510(k) submission to the US Food and Drug Administration (FDA), which is planned by the end of the year.. Intelligent Bio Solutions expects to launch the fingerprint drug screening technology in the US in 2025 and sees the technology being used for drug testing in multiple industries including law enforcement and forensics.

“The close correlation of PK parameters in fingerprint sweat and blood highlights its robustness as a sampling approach. While independent data has consistently supported this, our clinical study further reinforces these findings,” said Harry Simeonidis, president, and CEO of Intelligent Bio Solutions.

“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.”

The PK study compared the levels of opiates detected in fingerprint sweat with those found in blood, oral fluid, and urine samples following the medically supervised administration of codeine in 39 healthy participants. The fingerprint sweat samples were analysed using a validated, traceable liquid chromatography/tandem mass spectrometry.

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Another company developing a technology that detects the presence of drugs in the sweat is Epicore. In February, the company partnered with the US Anti-Doping Agency (USADA) to use its wearable sweat-collection device, Discovery Patch, for drug detection. The Discovery Patch collects the sweat samples which can then be used for drug and hydration analysis.