If authorised, the Proof Lab Test System can deliver accurate, functional, lab-quality results of the Covid-19 test in less than 18 minutes
The Proof Lab Test System is a cost-effective, rapid, and accurate Covid-19 testing platform. (Credit: Gerd Altmann from Pixabay)
US-based molecular diagnostics solutions provider Proof Diagnostics has submitted an emergency use authorisation (EUA) request for review to the US Food and Drug Administration (FDA) for its point-of-care (POC) molecular diagnostic test for Covid-19.
If approved by the US FDA, the test system will become the first point-of-care system to use CRISPR-based nucleic acid detection, providing a cost-effective, user-friendly, and easily scaled test.
The test will help clinicians and patients to attain laboratory-level sensitivity and specificity at the POC in as little as 18 minutes.
Proof Diagnostics co-founder Omar Abudayyeh said: “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.”
Abudayyeh added: “We hope that the FDA authorises our CRISPR-based test so that we can empower communities to navigate their next step in person with confidence and peace of mind.”
Proof Diagnostics co-founder and CEO Sid Shenai said: “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.”
Shenai added: “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.”
Established in May 2020, Proof Diagnostics provides a cost-effective, rapid, and accurate Covid-19 testing platform to help people stay safe during the pandemic.
Over the last 18 months, the firm developed a testing solution by advancing the CRISPR-based diagnostics approach STOPCovid.