FluroTest will employ its pre-production testing platform developed with its partner Hudson Robotics
FluroTech Ltd. (TSXV: TEST) (OTCQB: FLURF) (“FluroTech” or the “Company”), a leading developer of spectroscopy-based technology, together with joint venture FluroTest, LLC (“FluroTest”), a first-mover in surge-scale rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, are pleased to announce that an agreement with Toolbox Medical Innovations (“Toolbox”) has been signed this week to carry out clinical trials of the FluroTest pandemic response platform alongside a comparator RT-PCR assay for performance detection of SARS-CoV-2 in saliva samples.
Toolbox Medical Innovations is an ISO 13485-certified consumables development firm and a full contract research organization (CRO) specializing in needs of the point-of-care diagnostic and life science industry. With a network consisting of over 100 clinical sites and over 50 combined years of clinical research and regulatory support, IVD product engineering and medical device usability testing experience, Toolbox is well-versed in simplifying and expediting the complex FDA approval procedures. Toolbox has a profound expertise in helping organizations surpass each step of the submission process from clinical study design and development, all the way up to regulatory planning and support, allowing them to provide a fast and efficient path to FDA and other approvals for IVD diagnostic products.
FluroTest will employ its pre-production testing platform developed with its partner Hudson Robotics. FluroTest is aiming to enroll approximately 600 volunteer participants, including both symptomatic and asymptomatic individuals. The clinical trials are anticipated to begin by mid-April. The data collected will be used to support FluroTest’s submission for Emergency Use Authorization (“EUA”) from the U.S. Food and Drug Administration (“FDA”) and Health Canada for an Interim Order Authorization. Future submissions to additional regulatory bodies around the globe are also being considered.
“We continue to take measured steps in our execution and remain laser-focused on our objectives. This is a significant point in our path forward and we aim to ensure a smooth, timely, and accurate process,” said Bill Phelan, CEO of FluroTest. “Partnering with Toolbox allows us to leverage decades of clinical trial experience with professionals who have organized and executed clinical studies for Ellume and LumiraDx which have secured FDA EUA status. The goal of 600 participants, utilizing multiple clinical research institutions throughout North America, exceeds regulatory requirements. Suffice it to say our confidence and commitment to product validation remain strong. We believe the data endpoints will reflect favorably for our submission.”
“We are proud to bring decades of clinical trial, useability testing, regulatory and manufacturing experience to bear as we partner with FluroTest to conduct these clinical trials.” noted John Zeis, President of Toolbox Medical Innovations. “Enabling people to congregate in large venues such as stadiums, arenas, and large corporate environments safely and securely is critical to opening our economy. We are proud to be conducting clinical trials focused on enabling this.”
“With numerous research studies and trials to date, Toolbox is dedicated to bettering the medical community and enhancing population health. This dedication will ensure a stringent evaluation of our technology for the detection of the SARS-CoV-2 antigen in a clinical laboratory environment,” added FluroTech R&D Director and Senior Scientist, Dr. Mauricio Arias. “In collaboration with Toolbox’s research team, our clinical study is designed to surpass current FDA requirements for Emergency Use Authorization and is structured to demonstrate the efficacy of our antigen detection technology.”
Readers are cautioned that, although FluroTest has achieved proof of concept prototype, the testing method and device is still in the early stages of research and development and accordingly FluroTest is not currently making any express or implied claims that the technology can, or will be able to, accurately detect the COVID-19 virus. The Platform is in the process of applying for EUA approval from the FDA and Health Canada for an Interim Order Authorization.
Source: Company Press Release