Proof Diagnostics has submitted an application seeking emergency use authorization (EUA) for its point-of-care (POC) Covid-19 test, Proof Lab Test System, from the US Food and Drug Administration (FDA).
The Covid‑19 molecular diagnostic test is intended to help communities have control over their health.
The company has developed a small, portable smart device over the past 18 months by advancing the CRISPR-based diagnostics method, STOPCovid.
The new Proof Lab Test System has been designed to make testing simple, scalable and reliable.
If approved by the FDA, the testing solution is expected to become the first POC system to use CRISPR-based nucleic acid detection.
Proof Diagnostics co-founder and CEO Sid Shenai said: “Submitting our EUA to the FDA 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.”
The modular and portable device provides cost-effective, user-friendly and easily scalable testing of Covid-19. It delivers accurate, laboratory-quality results in 18 minutes.
The company stated that the research on the new device has been supported by the National Institutes of Health (NIH) RADx programme, as well as the Defense Advanced Research Projects Agency (DARPA) and the Gates Foundation.
To date, Proof Diagnostics has secured $45m funding from investors, including Madrona Venture Group, F-Prime Capital and ARCH Venture Partners.