First-Ever CRISPR-Based POC System Delivers COVID-19 Test Results in 18 Minutes

A CRISPR-based molecular point-of-care (POC) COVID-19 test may be used to deliver accurate, actionable, lab-quality results for SARS-CoV-2 in as little as 18 minutes.

Proof Diagnostics, Inc. (Cambridge, MA, USA) has announced the submission of its Emergency Use Authorization (EUA) request for review to the U.S. Food and Drug Administration (FDA) for its POC molecular diagnostic test for COVID-19 (SARS-CoV-2). If authorized, the Proof Lab Test System would be the first POC system that employs CRISPR-based nucleic acid detection to offer 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.

The Proof Lab Test System comprises small, modular and portable equipment that is easy to set up and operate. The low-cost reader and cartridges make testing scalable. The system uses highly sensitive detection methods and gold-standard specificity to rapidly complete the process from sample collection to results in as little as 22 minutes.

Additionally, the company is designing the Proof Diagnostics mobile app to seamlessly connect with up to six Proof Lab readers via Bluetooth. This will allow users to monitor the progress of multiple COVID-19 tests, keep and view up to 50 results filtered by time and date on each synced reader, and easily export detailed test results. The company is also designing its app to enable third-party integrations - to EHRs, for example - and the storage of large volumes of data in its HIPAA-compliant cloud solution.

"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."

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Proof Diagnostics, Inc.

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