Intelligent Bio Solutions Inc. Reports Positive Results from PK Study in Pursuit of FDA 510(k) Submission

On November 13, 2024, Intelligent Bio Solutions Inc. (INBS), a medical technology company, unveiled encouraging findings from its Pharmacokinetic (PK) study aimed at fulfilling requirements for an FDA 510(k) submission.

The PK study highlighted that fingerprint sweat can serve as a reliable sample matrix for drug detection, closely mirroring the rate and extent of codeine in blood and saliva. Independent data and the recent clinical study emphasized the robustness of fingerprint sweat as a sampling approach, as stated by Harry Simeonidis, President and CEO of Intelligent Bio Solutions.

These promising outcomes pave the way for INBS to potentially secure FDA 510(k) clearance, which would enable the introduction of its innovative drug screening technology to the US market by 2025. The Company is preparing to submit the PK study results and relevant clinical data as part of its 510(k) submission in the fourth quarter of the present year.

The PK study, executed in collaboration with Cliantha Research, involved over 39 healthy adult subjects from diverse backgrounds. Comparisons of opiate levels in fingerprint sweat with those in blood, oral fluid, and urine samples were conducted following the supervised administration of codeine.

INBS’s Intelligent Fingerprinting Drug Screening System analyzed all fingerprint sweat specimens, demonstrating rapid and reliable drug screening without intrusive procedures. The application of liquid chromatography/tandem mass spectrometry (LC-MS/MS), acclaimed as the gold standard, solidified the study’s integrity.

Intelligent Bio Solutions Inc., listed on the Nasdaq Stock Market under the symbol INBS, specializes in innovative, non-invasive testing solutions. The Company’s Intelligent Fingerprinting Drug Screening System offers efficient fingerprint sweat analysis for drug detection, with potential uses in various sectors outside the US, such as construction, manufacturing, and drug rehabilitation.

While this announcement signifies a substantial leap towards FDA clearance, Intelligent Bio Solutions Inc. persists in its dedication to advancing its groundbreaking technology for widespread adoption across safety-critical industries and beyond.

For more information regarding INBS’s technology and developments, please visit their website at http://www.ibs.inc/.

This article was generated by an automated content engine and was reviewed by a human editor prior to publication. For additional information, read GBS’s 8K filing here.

GBS Company Profile

GBS Inc operates as a biosensor diagnostic technology company in the Asia-Pacific and North America. It offers Saliva Glucose Biosensor, an organic thin-film transistor for diabetes management that measures glucose in saliva. The company also focuses on developing SARS-CoV-2 Biosensor, a biosensor test can be used as a complement to the (RNA) virus detection test; and a biosensor platform comprising of biochemistry, immunology, tumor markers, hormones, and nucleic acid diagnostic modalities.