eClinical Technology and Industy News

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

Excerpt from the Press Release:

CAMBRIDGE, Mass., April 7, 2022 /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.

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