Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
ZeptoMetrix an Antylia scientific company

Download Mobile App





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

By LabMedica International staff writers
Posted on 11 Apr 2022

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. More...

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."

Related Links:
Proof Diagnostics, Inc.


Platinum Member
SARS-CoV-2 Reactive & Non-Reactive Controls
Qnostics SARS-CoV-2 Typing
Verification Panels for Assay Development & QC
Seroconversion Panels
Anti-Cyclic Citrullinated Peptide Test
GPP-100 Anti-CCP Kit
Gold Member
COVID-19 Antigen Self-Test
Panbio COVID-19 Antigen Self-Test
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








Channels

Clinical Chemistry

view channel
Image: QIP-MS could predict and detect myeloma relapse earlier compared to currently used techniques (Photo courtesy of Adobe Stock)

Mass Spectrometry-Based Monitoring Technique to Predict and Identify Early Myeloma Relapse

Myeloma, a type of cancer that affects the bone marrow, is currently incurable, though many patients can live for over 10 years after diagnosis. However, around 1 in 5 individuals with myeloma have a high-risk... Read more

Immunology

view channel
Image: The cancer stem cell test can accurately choose more effective treatments (Photo courtesy of University of Cincinnati)

Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer

Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more

Technology

view channel
Image: Ziyang Wang and Shengxi Huang have developed a tool that enables precise insights into viral proteins and brain disease markers (Photo courtesy of Jeff Fitlow/Rice University)

Light Signature Algorithm to Enable Faster and More Precise Medical Diagnoses

Every material or molecule interacts with light in a unique way, creating a distinct pattern, much like a fingerprint. Optical spectroscopy, which involves shining a laser on a material and observing how... Read more

Industry

view channel
Image: The collaboration aims to leverage Oxford Nanopore\'s sequencing platform and Cepheid\'s GeneXpert system to advance the field of sequencing for infectious diseases (Photo courtesy of Cepheid)

Cepheid and Oxford Nanopore Technologies Partner on Advancing Automated Sequencing-Based Solutions

Cepheid (Sunnyvale, CA, USA), a leading molecular diagnostics company, and Oxford Nanopore Technologies (Oxford, UK), the company behind a new generation of sequencing-based molecular analysis technologies,... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.