1 July 2020 - - US-based molecular diagnostics specialist Sherlock Biosciences and CT/NG testing specialist binx health 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 company said.

The organisations 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 US Food and Drug Administration 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.

The currently available Sherlock 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 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.

Sherlock Biosciences is focused on improving molecular diagnostics.

The company is developing applications of Sherlock, a CRISPR-based method to detect and quantify specific genetic sequences, and INSPECTR, a Synthetic Biology-based molecular diagnostics platform that is instrument free.

Sherlock and INSPECTR can be used in virtually any setting without complex instrumentation, opening up a wide range of potential applications in areas including precision oncology, infection identification, food safety, at-home tests, and disease detection in the field.

binx health has a molecular platform for CT/NG testing. The technology brings rapid, accurate and convenient infectious disease testing to people where they live, work and shop.

Its solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health.