Industry News: binx health submits request for Emergency Use Authorization for first CRISPR-based point-of-care test for COVID-19

Platform poised to be first CLIA-waived CRISPR-based, point-of-care COVID-19 device with central-lab performance, developed in collaboration with Sherlock Biosciences

18 May 2021

binx health has announced the submission of an Emergency Use Authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for the first CLIA-waived CRISPR-based point-of-care (POC) test for COVID-19. binx io is already the first CLIA-waived platform for the molecular detection of chlamydia and gonorrhea in about 30 minutes. binx has now adapted the single-use cartridge for analysis of RNA-based targets, pairing the high performance of Sherlock Biosciences’ proprietary CRISPR technology with binx’s rapid and sensitive proprietary electrochemical detection to create a powerful tool to help combat COVID-19. Data obtained in support of this authorization positions binx io at the forefront of rapid, POC molecular detection of both viral and bacterial infections.

“Today’s EUA application is a major milestone for the binx io platform and its capability to detect both viral and bacterial infections. If authorized authorization, the binx io will be a pivotal tool for increasing access to rapid COVID-19 testing and treatment, which is a necessity to control the spread of the disease and save lives,” said Jeffrey Luber, binx health Chief Executive Officer. “We believe single-visit diagnoses with our easy-to-use desktop device will reduce transmission and ultimately empower communities and individuals to return to in-person working and learning more quickly, and with more confidence than they would have otherwise. We are very grateful to our partners, including Sherlock Biosciences, RADx and Open Philanthropy for their integral contributions to this effort.”

binx io has the demonstrated ability to deliver actionable, central laboratory quality results for chlamydia and gonorrhea detection in about 30 minutes, improving upon the current standard of care, which often requires days to weeks between testing and treatment. Recently, the FDA granted a Clinical Laboratory Improvement Amendments (CLIA) waiver for the binx io system for the detection of chlamydia and gonorrhea.

“Last year, Sherlock made history with the first FDA authorization of CRISPR technology in diagnostics or therapeutics with our Sherlock™ CRISPR SARS-CoV-2 kit. We are excited to see binx translate our technology into what may be the first point-of-care CRISPR test FDA-authorized for use on patients,” said Rahul Dhanda, Co-founder, President and Chief Executive Officer of Sherlock Biosciences. “As the leader in CRISPR and Synthetic Biology diagnostics, Sherlock partnered with binx, a leader in point-of-care testing, to reach the millions of people served by over  220,000 locations with CLIA certificates of waiver. Together, we anticipate that we can significantly limit the spread of existing and new variants of the SARS-CoV-2 virus.”

The Company’s EUA submission along with its ongoing feasibility efforts is another example of the io’s potential to be applied across a range of viral and bacterial infections exemplifying the capability of the platform. Key expansions to the platform, including RNA detection capabilities made through the combination of CRISPR technology and proprietary electrochemical detection, allows the platform to detect COVID-19 infection with both speed and accuracy.

The currently available SherlockTM CRISPR SARS-CoV-2 kit uses the SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) method to program a CRISPR molecule to detect the presence of a specific SARS-CoV-2 genetic signature in specimens collected from patients suspected of COVID-19 by their healthcare provider. The kit is intended for use in CLIA laboratories to assay nasal swabs, nasopharyngeal swabs, oropharyngeal swabs or bronchoalveolar lavage (BAL) specimens. When the signature is found, the CRISPR enzyme is activated and releases a detectable signal, yielding results in about an hour. The kit is the first CRISPR-based diagnostic test to receive EUA from the FDA for qualitative detection of nucleic acid from SARS-CoV-2. Sherlock is also pressing forward in developing its INSPECTR at-home testing platform to create an instrument-free, handheld test – similar to that of an at-home pregnancy test – for the rapid detection of the SARS-CoV-2 virus.

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