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.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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.

See Also:

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“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.