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Intelligent Bio Solutions Inc. INBS recently announced positive initial results from its Pharmacokinetic (PK) study. The study is important for supporting FDA 510(k) clearance of the company’s Intelligent Fingerprinting Drug Screening technology.
Per the PK study's data, the amount and rate of codeine in blood and saliva are mimicked by fingerprint sweat. Based on 95% confidence level statistical comparisons, the study effectively demonstrated that fingerprint sweat offers a dependable sample matrix for drug detection, displaying quantitative PK data well aligned with blood.
Likely Trend of INBS Stock Following the News
Following the news annoucement, shares of the company have moved nearly 12.4% south to $1.48 on Friday’s closing . In the year-to-date period, INBS shares have plunged 63.5% compared with the industry’s 10.2% decline. The S&P 500 increased 23.4% in the same time frame.
Meanwhile, INBS currently has a market capitalization of $6.5 million.
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More on INBS’ Pharmacokinetic Study
INBS’ PK study is a key step in the company’s planned FDA 510(k) submission. FDA clearance is required to show that INBS’ fingerprint drug screening technology is safe and effective and would allow the company to enter the substantial U.S. market, currently planned for the first half of 2025.
The PK study, conducted in partnership with Cliantha Research, required a minimum of 36 subjects. INBS 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 using validated, traceable liquid chromatography or tandem mass spectrometry methods, widely accepted as the gold standard for such studies.
Per the study's findings, fingerprint sweat is a reliable sign of codeine ingestion. They further confirm that INBS' approach, which uses a straightforward fingerprint sweat sample and no intrusive procedures, may deliver quick and accurate drug screening. The PK study results and other clinical data from the company's clinical study plan are likely to be submitted as part of the company's 510(k) submission, expected in the fourth quarter of this year.
More on the INBS Intelligent Fingerprinting Drug Screening System
INBS' first-of-its-kind fingerprint drug screening technology uses fingerprint sweat to provide a quick, hygienic, and easy-to-use method for drug testing, delivering results in just minutes. This unique approach tests for common drugs of abuse, including cocaine, cannabis, methamphetamine, and opiates.