Intelligent Bio Solutions Releases Positive PK Study Results

Intelligent Bio Solutions Inc. is touting strong initial results from its Pharmacokinetic (PK) study required for a U.S. Food and Drug Administration (FDA) 510(k) submission. According to results, fingerprint sweat mimics the rate and extent of codeine in blood and saliva.

The study successfully demonstrated 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.

“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,” Intelligent Bio Solutions President/CEO Harry Simeonidis said. “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 United States.”

FDA 510(k) clearance would enable the company to introduce its drug screening technology to the U.S. market this year. Intelligent Bio Solutions believes it is well-positioned to meet the increasing demand for U.S. drug testing.

The study results show that fingerprint sweat is a strong indicator of codeine ingestion. They further validate the ability of Intelligent Bio Solutions’ method to provide rapid and reliable drug screening through a simple fingerprint sweat sample without invasive procedures.

The PK study, conducted in partnership with Cliantha Research, required at least 36 subjects. The company successfully recruited 39 healthy adult subjects from diverse backgrounds, including varying genders, ages, and ethnicities. The 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. All fingerprint sweat specimens collected using INBS’ Intelligent Fingerprinting Drug Screening System, were analyzed by a validated, traceable liquid chromatography/tandem mass spectrometry (LC-MS/MS) method, widely accepted as the gold standard for such studies.

Intelligent Bio Solutions Inc. is a medtech firm delivering rapid, non-invasive testing solutions. The company claims its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in various fields. Designed as a hygienic and cost-effective system, the test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under 10 minutes, this technology would be a valuable tool for employers in safety-critical industries.

* Urine results are not included in the chart. Due to the nature of urine sample collection, which depends on an individual’s need to urinate, samples cannot be collected at fixed intervals. Therefore, urine specimens were collected on an ad-lib basis as frequently as possible.