FluroTech Partners with Toolbox Medical Innovations for COVID-19 testing platform
FluroTest will employ its pre-production testing platform developed with its partner Hudson Robotics.
CALGARY — FluroTech Ltd., a developer of spectroscopy-based technology, together with joint venture FluroTest, LLC, a first-mover in surge-scale rapid antigen testing for the detection of SARS-CoV-2 and other pathogens, announces that an agreement with Toolbox Medical Innovations has been signed this week to carry out clinical trials of the FluroTest pandemic response platform.
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.
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 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.”