- FluroTech Ltd. (TEST) has signed an agreement with Toolbox Medical Innovations to carry out clinical trials of the FluroTest antigen testing platform
- Toolbox has expertise in helping organizations navigate each step of the submission process from clinical study to regulatory planning and support
- The data collected will support FluroTest’s submission for Emergency Use Authorization from the U.S. Food and Drug Administration and Health Canada
- FluroTest is a first-mover in surge-scale rapid antigen testing for the detection of SARS-CoV2 and other pathogens
- FluroTech is down 12.16 percent and is trading at C$0.65 at 2:49 pm EST
FluroTech (TEST) has signed an agreement with Toolbox Medical Innovations to carry out clinical trials of the FluroTest antigen testing platform.
FluroTech hopes to do this alongside a comparator RT-PCR assay for performance detection of SARS-CoV-2 in saliva samples.
With a network of over 100 clinical sites and more than 50 combined years of research support and testing, Toolbox has the resources to help organizations navigate each step of the submission process from clinical study design and development to regulatory planning and support. This expertise provides organizations with a faster and more 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 from the U.S. Food and Drug Administration 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.
“Suffice it to say our confidence and commitment to product validation remain strong. We believe the data endpoints will reflect favourably for our submission,” added Phelan.
“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[…]” added Zeis.
The goal of FluroTech’s research and technology is to develop detection methods that are sensitive, specific and easy-to-use. By combining FluroTest, a first-mover in surge-scale rapid antigen testing for the detection of SARS-CoV2 and other pathogens.
FluroTech is down 12.16 percent and is trading at C$0.65 at 2:49 pm EST.
