Advancements in FDA Submission Preparation by Intelligent Bio Solutions
Intelligent Bio Solutions Inc. (Nasdaq: INBS), a prominent name in the medical technology sector, is making strides with its clinical study plan that is crucial for the FDA 510(k) submission. This announcement represents a significant step in the company’s mission to provide innovative, rapid, and non-invasive testing solutions.
Collaboration and Method Comparison Study
In a strategic partnership, Intelligent Bio Solutions has teamed up with CenExel to conduct a method comparison study, which is a key part of its clinical study plan. This study aims to enroll 135 healthy adult participants across three locations, following a protocol approved by an Institutional Review Board (IRB). It will evaluate the results from fingerprint sweat opiate screening tests in comparison to a validated laboratory method that utilizes liquid chromatography-mass spectrometry (LC-MS/MS).
Enrollment and Progress of the Study
The company is excited to announce that it has achieved approximately one-third of its enrollment goals for this important study. Activities so far have included screening, obtaining consent, and collecting fingerprint sweat samples. Furthermore, the company has recently wrapped up the in-clinic phase of a pharmacokinetic (PK) study focused on opiates using human fingerprint sweat, and data analysis is currently in progress.
Insights from Leadership
Harry Simeonidis, President and CEO of Intelligent Bio Solutions, remarked, "Our team is working closely with our CRO partner to adhere to our timeline. We are hopeful about finishing the in-clinic segment of the method comparison study by the end of September, which is crucial for our 510(k) submission planned for the fourth quarter of this year." This determination highlights the company's dedication to advancing its innovative technologies.
Intelligent Fingerprinting Drug Screening System
The primary objective of these clinical studies is to validate the Intelligent Fingerprinting Drug Screening System. The focus is on proving that it is not only user-friendly but also delivers accurate results for opiate detection. This system signifies a major advancement in drug screening technology, leveraging the capabilities of fingerprint sweat analysis.
Transforming Drug Testing
The Intelligent Fingerprinting Drug Screening System is designed to be both hygienic and cost-effective. It allows for rapid sample collection in just seconds and produces results in under ten minutes. This efficiency is especially advantageous for employers in safety-sensitive industries. Additionally, the company’s biosensor platform has the potential to expand its testing capabilities to cover a variety of health indicators, including both immunological conditions and infectious diseases.
Target Customer Segments
Intelligent Bio Solutions caters to a wide array of client sectors, such as construction, manufacturing, logistics, drug rehabilitation programs, and forensic services. This extensive applicability emphasizes the system's potential impact across various industries, promising improved safety and efficiency in drug screening processes.
About Intelligent Bio Solutions Inc.
Intelligent Bio Solutions Inc. is dedicated to pioneering advancements in medical testing technologies. The company's innovative strategies aim to transform the landscape of portable testing through sophisticated methods that are both practical and effective.
Contact Information
For further inquiries:
Intelligent Bio Solutions Inc.
info@ibs.inc
For media and investor relations:
Valter Pinto, Managing Director
KCSA Strategic Communications
PH: (212) 896-1254
INBS@kcsa.com
Frequently Asked Questions
What is the latest announcement from Intelligent Bio Solutions?
The company has made significant progress in completing its clinical study plan for FDA 510(k) submission.
Who is Intelligent Bio Solutions' partner for the clinical study?
The company has partnered with CenExel to conduct a method comparison study.
What technology does Intelligent Bio Solutions utilize for drug testing?
They use the Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat samples.
What are the benefits of their drug testing system?
The system is quick, hygienic, and provides results in under ten minutes, making it ideal for safety-critical industries.
Which sectors does Intelligent Bio Solutions serve?
They cater to construction, manufacturing, transport logistics, drug treatment organizations, and coroner services.
