The data from our pharmacokinetic (PK) study shows that fingerprint sweat mimics the rate and extent of codeine in blood and saliva. The study demonstrated that fingerprint sweat provides a reliable sample matrix for drug detection, showing quantitative PK data closely aligned to blood and oral fluid. President & CEO Harry Simeonidis discusses the results in more detail in this informative video.
Read the Press Release here.
INBS PK Study Results Transcript
Hi, my name is Harry Simeonidis, President and CEO of Intelligent Bio Solutions Inc. Thanks for joining us today as we share the results of our PK study and road to FDA submission.
Please briefly overview the recent PK study and its importance for Intelligent Bio Solutions.
All our clinical studies are reviewed and approved by an ethics committee. We always pay the utmost attention to the safety of the subjects who participated in this study. The PK study is a requirement for FDA submission, and it’s designed to demonstrate that fingerprint sweat is a reliable sample for drug detection. We partnered with a clinical research organization, Cliantha Research, based in Canada. We tested 39 healthy adult subjects, which is more than enough to draw a statistically valid conclusion from our study.
The 24-hour in-clinic study compared the levels of coding detected in fingerprint sweat with those found in blood, oral fluid, and urine samples following the medically supervised administration of codeine. Specimens were collected by obtaining a fingerprint sweat sample on our screening cartridge.
Subjects then washed their hands and were monitored for 15 minutes to ensure they didn’t touch anything. A second fingerprint sweat sample was then collected on our confirmation cartridge, followed by an oral fluid specimen, an intravenous blood sample, and, if possible, a urine sample.
These clinical samples were then analyzed by a bioanalytical laboratory using state-of-the-art equipment and procedures. The PK study is an integral part of our FDA 510k submission, which is required for planned market entry into the United States. We needed to complete the PK study to show that fingerprint sweat is a valid sample type for drug detection.
So, how did the results align with the company’s expectations and overall goals for the study?
We’re pleased that these results confirm that fingerprint sweat is a strong indicator of codeine ingestion and validate the ability of our technology to provide a rapid and reliable drug screening sample through fingerprint sweat without invasive procedures.
The study results confirm that fingerprint sweat is a strong indicator of codeine ingestion. The results validate the ability of our technology to provide rapid and reliable drug screening through a simple fingerprint sweat sample without invasive procedures. The results show that fingerprint sweat closely aligns with blood and oral fluid and mimics the rate and extent of codeine in these two other sample types.
Our goal has always been to submit our 510k package to the FDA by the end of 2024. Part of this plan was to complete the PK study in Q3. We are pleased that we are on track to submit, and our skilled team executed and completed the PK study on time and within budget. The results reaffirm our data and understanding of fingerprint sweat and that it is a viable method for drug detection.
What were the key findings from the PK study, and what do they indicate about our technology and its potential?
We previously conducted a pilot study. The results from this study of the 39 subjects match the pilot study results. Furthermore, the PK parameters calculated from blood and oral samples in our studies match the parameters published by other research for codeine in blood and oral fluids. The data from the study indicates that fingerprint sweat can be used to detect opiates such as codeine in a person’s system. This now offers an alternative to urine, blood, or saliva testing, which can be invasive, expensive, and sometimes difficult to collect the samples.
How will these results impact the next steps for the business and entry into new markets like the USA?
Since fingerprint sweat is a novel solution for drug screening in the U.S. market, the PK data is important to support our FDA submission. These results further prove that sweat is a viable method for drug screening and will allow us to expand into other regions with data-backed solutions. If cleared by the FDA, we can start providing our solution for drug screening in the U.S.
What are the next steps for Intelligent Bio Solutions, and what should we look forward to in the coming months?
We will announce the results of our method comparison study in Q4, another key component of our clinical study plan. We are also compiling the results from our other clinical and laboratory studies required as part of the FDA submission. We plan to submit all of this in Q4 this year. We will continue to pursue our strategic geographical expansion plans and enter new segments throughout the globe.
Thanks for watching this video, and I hope you find the results as exciting as we do.
