News | April 7, 2022

Proof Diagnostics Submits Request For Emergency Use Authorization Seeking First Approval Of CRISPR-Based Molecular Point-Of-Care Covid-19 Test

If authorized by the FDA, the Proof Lab Test System may be used to deliver accurate, actionable, lab-quality results for COVID-19 (SARS-CoV-2) in as little as 18 minutes

Cambridge /PRNewswire/ - Proof Diagnostics, Inc., an innovative healthcare technology company delivering innovative solutions in molecular diagnostics, today announced the submission of its Emergency Use Authorization (EUA) request for review to the U.S. Food and Drug Administration (FDA) for its point-of-care (POC) molecular diagnostic test for COVID-19 (SARS-CoV-2). If authorized, the Proof Lab Test System would be the first POC system employing CRISPR-based nucleic acid detection offering a cost-effective, user-friendly, and easily scalable test. The company's hope is to allow clinicians and patients to achieve laboratory-level sensitivity and specificity at the POC in as little as 18 minutes.

Proof Diagnostics was founded in May 2020 to help people stay safe during the pandemic by providing a cost-effective, rapid, and accurate COVID-19 testing platform. 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, Ph.D., Omar Abudayyeh, Ph.D., Jonathan Gootenberg, Ph.D., 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," said Omar Abudayyeh, co-founder of Proof Diagnostics.

"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," said 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 and its vision of improving global public health by staying at the forefront of infectious disease detection, visit

About Proof Diagnostics:
Proof Diagnostics, Inc. has established itself as an innovative healthcare technology company focused on delivering innovative solutions in molecular diagnostics. Proof's mission is to empower the public to take control of, and better understand, their overall health through lab-quality molecular testing, initiating with COVID-19, that is easy to use, accurate and cost-effective. The Proof Lab Reader is a portable, scalable diagnostic device that utilizes a Proof Lab Test Cartridge and Proof Lab Test Kit to provide lab-quality results and actionable diagnostic information, helping people lead better, healthier lives.

Source: Proof Diagnostics

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