Proof Diagnostics, a healthcare technology company delivering solutions in molecular diagnostics, announced the submission of its Emergency Use Authorization (EUA) request for review to the U.S. Food and Drug Administration (FDA) for its COVID POC molecular diagnostic test.
The company hopes this authorization will allow clinicians and patients to achieve laboratory-level sensitivity and specificity at the POC in as little as 18 minutes.
Over the past 18 months, the company developed a robust and scalable testing solution by advancing the CRISPR-based diagnostics method STOPCovid developed by world-renowned CRISPR diagnostics pioneers Feng Zhang, PhD, Omar Abudayyeh, PhD, Jonathan Gootenberg, PhD, and colleagues. Teamed with entrepreneur Sid Shenai, CEO, the company licensed STOPCovid from the Broad Institute in late 2020, improved upon it, and developed a small, portable smart device, along with enabling software and cloud infrastructure. The research has been supported by NIH’s RADx program, DARPA, and the Gates Foundation. Additionally, Proof has raised $45 million to date from investors including ARCH Venture Partners, F-Prime Capital, and Madrona Venture Group.
“The delivery of novel chemistry, combined with Proof’s innovative technology platform, to FDA EUA submission in less than two years is no small feat. CRISPR has long promised to make a difference in peoples’ lives and we are incredibly proud of the scientific innovation that our team developed. We hope that the FDA authorizes our CRISPR-based test so that we can empower communities to navigate their next step in person with confidence and peace of mind,” says Omar Abudayyeh, co-founder of Proof Diagnostics.
Proof Diagnostics was founded in May 2020 to help people stay safe during the pandemic by providing a rapid, and accurate COVID-19 testing platform
“Submitting our EUA to the Food and Drug Administration is a significant achievement for Proof Diagnostics as we embark on the future of rapid POC and at-home testing, ensuring optimal accuracy to help detect disease prior to the demonstration of symptoms. The Proof Lab Test System has the potential to become a valuable tool for clinicians and patients to make more informed health decisions that can help deter the spread of disease,” says Sid Shenai, co-founder and CEO of Proof Diagnostics. “The passion and dedication of our team here, and all our partners, cannot go unnoticed. We want to acknowledge everyone who has made this milestone possible and we will continue to push forth a vision for accessible healthcare.”
To learn more about Proof Diagnostics, visit www.proofdx.com.