Intelligent Bio Solutions Inc. (INBS) has announced positive results from its Pharmacokinetic (PK) study, a key milestone towards FDA 510(k) submission. The study demonstrates that fingerprint sweat effectively mirrors codeine levels in blood and saliva, validating it as a reliable sample matrix for drug detection. This non-invasive approach could revolutionize drug screening across various sectors.
The PK study, conducted in partnership with Cliantha Research, involved 39 healthy adult subjects from diverse backgrounds, exceeding the minimum requirement of 36 subjects. Researchers compared opiate levels detected in fingerprint sweat with those found in blood, oral fluid, and urine samples following medically supervised codeine administration. All fingerprint sweat specimens, collected using INBS' Intelligent Fingerprinting Drug Screening System, were analyzed by a validated liquid chromatography/tandem mass spectrometry (LC-MS/MS) method, considered the gold standard for such studies.
Fingerprint Sweat as Reliable Sample Matrix
The data from the PK study indicates that fingerprint sweat mimics the rate and extent of codeine in blood and saliva. Statistical comparisons at a 95% confidence level showed quantitative PK data closely aligned with blood samples. This close correlation highlights the robustness of fingerprint sweat as a sampling approach for drug detection.
"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.
Path to FDA 510(k) Clearance and Market Entry
INBS plans to submit the PK study results and other clinical data as part of its 510(k) submission, expected in the fourth calendar quarter of this year. FDA 510(k) clearance would enable INBS to introduce its innovative drug screening technology to the US market in 2025. The company is well-positioned to meet the increasing demand for drug testing, particularly in safety-critical industries like construction, mining, and transportation, as well as in law enforcement, drug rehabilitation, and forensic sectors.
Potential Impact and Market Opportunities
The fingerprint-based testing platform could capture significant market share in safety-critical industries, offering advantages over traditional invasive testing methods. The non-invasive nature of the technology addresses key pain points in current testing methods. The US drug testing market presents substantial opportunities, particularly in regulated sectors like construction, transportation and law enforcement.
With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. The test screens for the recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis.
