Sherlock Biosciences and binx health have announced the companies have entered into a strategic partnership to develop the world’s first rapid, point-of-care diagnostic test for COVID-19 leveraging CRISPR technology. The organizations will combine the binx io diagnostic platform with SHERLOCK™ CRISPR technology to create a test that is robust and simple to use. This unique solution is designed to provide rapid and accurate results in a single patient visit across many diverse CLIA-waived settings, such as clinics, doctors’ offices, assisted living centers, pharmacies and other easily accessible consumer venues, which will assist in broadening ways of managing potential resurgences of the pandemic. The combination of technologies also portends strong positioning for other viral threats as they emerge.
The binx io is the fastest molecular platform in the world that has U.S. Food and Drug Administration (FDA) clearance for chlamydia and gonorrhea testing. The Company’s platform is based on a proprietary detection method that makes it suitable for broad application across infectious diseases. The platform has a demonstrated ability to rapidly detect complex infectious disease targets from bodily fluids with very high accuracy. The binx io molecular platform consists of an easy-to-use, desktop-sized instrument and single-use cartridge with multiplex capacity of up to 24 targets. Once a patient sample is added to the cartridge and loaded into the io instrument, the process is fully automated, requires no interpretation of data, and is designed to produce a clearly indicated onscreen “detected” or “not detected” result.
“We are pleased to partner with Sherlock Biosciences to help bridge a gap in COVID-19 testing—the need for highly accurate point-of-care diagnostic testing in CLIA-waived and near-patient settings,” said Jeff Luber, chief executive officer of binx health. “In April of this year, binx health made history with the first 30-minute, FDA-cleared molecular diagnostic instrument for chlamydia and gonorrhea in both men and women that for the first time delivers same-visit diagnoses. Our proprietary platform will now leverage Sherlock’s CRISPR-based assay combined with binx’s electrochemical detection for rapid viral detection of SARS-CoV-2 without the need for additional instrumentation. This union of technologies is designed to enable physicians, clinicians and other healthcare workers on the front lines of the global COVID-19 pandemic to make on-the-spot care decisions and to control and prevent further infections. We also have a unique alignment of vision with Sherlock for solutions that support ‘everywhere’ testing in near-patient retail and clinical settings.”
“This collaboration with binx health to advance our SHERLOCK diagnostic platform and offer an accurate, point-of-care test is the next critical step in combating the global COVID-19 crisis,” said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences. “We are also excited to explore with binx how to utilize the io platform to bring accurate and affordable testing to hospitals, urgent care centers and other healthcare facilities for a range of diagnostic tests beyond COVID-19. We agree with the binx strategy that ‘everywhere care’ depends on highly accurate in-clinic and easy-to-use at-home solutions. Through both our SHERLOCK- and INSPECTR™-based platforms, we hope to serve as part of the solution to addressing the COVID-19 pandemic by making accurate, affordable diagnostics available everywhere they are needed: in the lab, point-of-care locales, low-resource settings and the home.”
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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