FluroTech expands nanoComposix mandate
FluroTest aims to get FDA approval for testing platform.
CALGARY — FluroTech Ltd. announces that FluroTest has retained San Diego-based nanoComposix, a life sciences nanotechnology company that specializes in R&D and manufacturing of lateral flow rapid tests, to immediately begin lab performance studies for FluroTest’s rapid antigen testing pandemic defense platform. This move builds upon previously announced and ongoing optimization efforts, bringing FluroTest one step closer to submitting to the U.S. Food and Drug Administration for Emergency Use Authorization (EUA).
Having already recorded successful proof of concept studies at Albany Medical College’s immunology laboratories, these performance and validation studies will be conducted in accordance with the FDA requirements for antigen testing, including but not limited to; assessments for sensitivity, specificity, limit of detection, cross-reactivity and interfering substances using inactivated viral culture samples. nanoComposix will follow the guidelines for performance studies outlined by the Antigen Template for Test Developers.
“We’re moving methodically but swiftly, and conducting lab evaluations is the next logical milestone to tackle as we march toward commercialization,” said FluroTest CEO, Bill Phelan. “We believe that these performance studies will reaffirm our efforts to introduce this novel solution to a massive, underserved market. My goal is to not only make FluroTest an icon of scientific culture, but rather an icon of our culture at large.”
nanoComposix has worked with over 100 different clients to develop materials, composites and formulations with tailored optical and physical properties for a wide range of applications including medical devices, nanoparticle drug delivery, optical sensors, and consumer products. A multidisciplinary team of scientists with backgrounds in chemistry, physics, and engineering have been tapped to run the evaluations, utilizing nanoComposix’s in-house BSL-2 laboratory for handling inactivated viral cultures.
“FluroTest has developed a Covid-19 diagnostic platform that we anticipate will be able to screen thousands of people per platform each hour – an unprecedented throughput that will be necessary to re-open the economy,” said Steve Oldenburg, CEO of nanoComposix. “We believe that the powerful combination of nanoComposix’ ultra-sensitive detection technology with state of the art robotics automation will be a revolutionary advance in Covid-19 diagnostic testing.”