Intelligent Bio Solutions Completes In-Clinic Portion of Pharmacokinetic (PK) Study Part of 510(k) Pathway for Approval & Commences Review of Results
Intelligent Bio Solutions (Nasdaq: INBS) has successfully completed the in-clinic portion of its pharmacokinetic (PK) study, a critical step in its 510(k) regulatory approval pathway for their fingerprint sweat drug screening technology. The study aims to validate that results from fingerprint sweat are comparable to traditional matrices such as blood, saliva, and urine. The dosing and sampling of the second cohort were concluded on June 27, 2024. The company is now analyzing the specimens using liquid chromatography/mass spectrometry (LC-MS) methods and expects to finalize the full PK study by the third quarter of 2024. This innovative technology promises a quick, hygienic, and easy-to-use method for detecting common drugs of abuse, including cocaine, cannabis, methamphetamine, and opiates.
- Successful completion of the in-clinic portion of the PK study.
- Completion of dosing and sampling on schedule.
- Ongoing analysis using validated LC-MS methods.
- Expectations to finalize the full PK study by Q3 2024.
- None.
Insights
The completion of the in-clinic portion of Intelligent Bio Solutions' pharmacokinetic (PK) study is a significant milestone in their 510(k) regulatory approval pathway. This stage involved thorough testing to ensure that the company’s novel fingerprint sweat collection method is on par with traditional specimen matrices like blood, saliva and urine. Comparing results from fingerprint sweat to these conventional methods is critical for validating the technology's efficacy.
It’s important to understand that the PK study is foundational in establishing the reliability and accuracy of a new drug testing method. By using liquid chromatography/mass spectrometry (LC-MS), a highly accurate analytical technique, INBS aims to present concrete data supporting their technology. This could potentially revolutionize the drug testing market by offering a quick, non-invasive and hygienic alternative. From a medical research perspective, if the results prove comparable, this method could see widespread adoption in clinical settings and beyond.
For retail investors, the successful completion of this phase indicates that the company is moving forward as planned, reducing some uncertainties associated with regulatory hurdles. However, the ultimate success hinges on the final data analysis and regulatory approval, which remains a key risk factor in the short term. Long-term, if successful, this technology could open up significant market opportunities, positioning INBS as a pioneer in a potentially new drug testing standard.
From a market perspective, the successful completion of the in-clinic portion of the PK study and the commencement of data analysis are encouraging signs for Intelligent Bio Solutions. The company’s fingerprint sweat collection technology addresses a significant need for quicker, less invasive drug testing methods. Current drug testing procedures can be time-consuming and invasive, making this a potentially disruptive technology in sectors like workplace testing, law enforcement and clinical diagnostics.
Should the PK study results validate the effectiveness of this method, we could see a swift market penetration due to the ease and speed of the testing process. This could give INBS a competitive edge, especially in markets where rapid drug testing is critical. Analyzing the potential market size, the segments dealing with drug abuse screening are substantial, thus presenting significant revenue opportunities.
For retail investors, it’s important to monitor the forthcoming data analysis and the subsequent steps towards regulatory approval. Successful validation could drive stock momentum as the market starts to price in the technology's potential and future revenue streams. While the short-term focus will be on upcoming results, the long-term outlook remains positive contingent on successful approval and adoption of the technology.
NEW YORK, June 28, 2024 (GLOBE NEWSWIRE) -- Intelligent Bio Solutions Inc. (Nasdaq: INBS) ("INBS" or the "Company"), a medical technology company delivering intelligent, rapid, non-invasive testing solutions, today announced the successful completion of the in-clinic portion of its pharmacokinetic (PK) study, a core component of the Company's clinical study plan for its 510(k) pathway for regulatory approval.
Dosing and sampling of the second cohort for the study concluded on Thursday, June 27, 2024, marking the completion of this phase and the end of the in-clinic portion of the study. The PK study aims to demonstrate that the Company's fingerprint sweat collection method provides results comparable to those from other specimen matrices, such as blood, saliva, and urine.
"Thanks to the smooth execution of subject dosing and sampling by our clinical research partner, Cliantha Research, we have completed this portion of our PK study according to the planned schedule. We are now focused on analyzing the test results and compiling the data to finalize the report and complete the study," commented Peter Passaris, Vice President of Product Development at INBS.
The specimens are currently being analyzed using validated, traceable liquid chromatography/mass spectrometry (LC-MS) methods. The subsequent data analysis from the PK trial will compare the detection of opiates in fingerprint sweat versus blood, saliva, and urine specimens. The Company expects to complete the full PK study in the third calendar quarter of 2024.
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.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. (NASDAQ: INBS) is a medical technology company delivering innovative, rapid, non-invasive testing solutions. The Company believes that its Intelligent Fingerprinting Drug Screening System will revolutionize portable testing through fingerprint sweat analysis, which has the potential for broader applications in additional fields. Designed as a hygienic and cost-effective system, the test screens for recent use of drugs commonly found in the workplace, including opiates, cocaine, methamphetamine, and cannabis. With sample collection in seconds and results in under ten minutes, this technology would be a valuable tool for employers in safety-critical industries. Additionally, the Company's biosensor platform has the potential to test for various indications, ranging from immunological conditions to communicable diseases. The Company's current customer segments include construction, manufacturing and engineering, transport and logistics firms, drug treatment organizations, and coroners.
For more information, visit: http://www.ibs.inc/
Forward-Looking Statements:
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. Forward-looking statements in this press release include, without limitation, Intelligent Bio Solutions Inc.'s ability to successfully develop and commercialize its drug and diagnostic tests, realize commercial benefit from its partnerships and collaborations, and secure regulatory approvals, among others. Although Intelligent Bio Solutions Inc. believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. Intelligent Bio Solutions Inc. has attempted to identify forward-looking statements by terminology, including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, included in Intelligent Bio Solutions' public filings filed with the Securities and Exchange Commission. Any forward-looking statements contained in this release speak only as of its date. Intelligent Bio Solutions undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
Company Contact:
Intelligent Bio Solutions Inc.
info@ibs.inc
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Investor & Media Contact:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
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