The system aimed to compare the outcomes of fingerprint sweat opiate screening tests with those from a laboratory-based liquid chromatography-mass spectrometry method. Credit: © Copyright 2024 Intelligent Bio Solutions Inc. All rights reserved.

Intelligent Bio Solutions (INBS) has completed the method comparison study of its ‘Intelligent Fingerprinting Drug Screening System’, confirming its usability, accuracy, specificity, and sensitivity.

This development follows the company’s positive initial outcomes from its pharmacokinetic (PK) study, marking its 510(k) submission to the US Food and Drug Administration (FDA).

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Conducted in partnership with CenExel, the ‘Method Study’ adhered to the standards of clinical research including the guidelines of good clinical practice (GCP).

It aimed to compare the outcomes of fingerprint sweat opiate screening tests with those from a laboratory-based liquid chromatography-mass spectrometry (LC-MS/MS) method.

It involved nine system operators and 135 healthy donors. The outcomes demonstrated the system’s specificity of 100%, accuracy of 94.1%, and 82.2% sensitivity.

Operators reported that the system is easy to use, with no errors during the study.

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The system’s components, including the drug screening cartridge, reader, and fingerprint collection kit, were assessed for their potential to identify and quantify drug use.

The outcomes of the Method Study underscore the system’s reliability, making it suitable for pre-employment and drug testing applications in the workplace.

Additionally, the system claims to offer cost savings, risk reduction and expanded testing capabilities, enabling screening at any location.

The company anticipates introducing its fingerprint sweat-based drug screening technology by next year to the US market, upon the receipt of 510(k) clearance.

It also plans to include data from both the PK and Method Studies in its 510(k) submission, expected in the last quarter of this year.

Intelligent Bio Solutions president and CEO Harry Simeonidis said: “The results of our Method Study reaffirm the accuracy and reliability of our fingerprint-based drug screening system.

“By establishing alignment with laboratory-confirmed results through rigorous testing, we have solidified our drug screening system’s credibility for use in safety-critical industries and beyond. This accomplishment is a significant step on our journey toward transforming drug testing with non-invasive technology.”