Sherlock Biosciences and binx health said today they intend to develop the world’s first rapid, point-of-care diagnostic test for COVID-19 leveraging CRISPR technology, through a strategic partnership whose value was not disclosed.
The companies said they will combine the binx io diagnostic platform with SHERLOCKTM CRISPR technology in a test that will be designed to deliver results in a single-patient visit across many CLIA-waived settings, such as clinics, doctors’ offices, assisted-living centers, pharmacies, and other accessible venues for consumers.
Sherlock and binx health said they plan to launch the test in the second half of 2020.
The binx io molecular platform has received FDA clearance for chlamydia and gonorrhea testing—the fastest such test to obtain agency clearance, according to binx health—as well as a proprietary method designed to detect infectious disease targets from bodily fluids. The platform consists of a desktop-sized instrument and a single-use cartridge with multiplex capacity up to 24 targets. After a patient’s sample is added to the cartridge and loaded into the instrument, the process is fully automated and will produce a “detected” or “not detected” onscreen 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,” Jeff Luber, CEO of binx health, said in a statement.
In April, binx health unveiled a 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 eletrochemical detection for rapid viral detection of SARS-CoV-2 without the need for additional instrumentation,” Luber added. “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.”
Rahul Dhanda, co-founder, president, and CEO of Sherlock Biosciences also stressed the importance of being able to make on-the-spot care decisions.
“The response to provide high-volume testing, including Sherlock’s own, has increased access to crucial results during the pandemic,” Dhanda told Clinical OMICs’ sister publication Genetic Engineering & Biotechnology News. “While we have solutions for individuals who can reach hospitals, we still need to make testing accessible in other areas, like pharmacies, to empower individuals to proactively make decisions to improve their health, as well as prevent potential spread to those in their communities.
Dhanda said Sherlock agrees with binx health’s strategy of “everywhere care” that depends on highly accurate in-clinic and easy-to-use at-home solutions. Sherlock hopes to help address the COVID-19 pandemic by making diagnostics available everywhere they are needed.
The current 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 SHERLOCK CRISPR SARS-CoV-2 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.
In May, the kit became the first CRISPR-based diagnostic test to receive FDA emergency use authorization (EUA) for qualitative detection of nucleic acid from SARS-CoV-2.
Sherlock also said it is moving 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.
Back in May, Clinical OMICs spoke with Dhanda as Sherlock was establishing relationships with suppliers, manufacturers, and partners. Dhanda had expressed their hopes “for the best outcome for public health.”
Sherlock started working on COVID-19 detection in January, Dhanda said, adding that CRISPR-based tests can be developed as soon as Sherlock can gain knowledge of the sequences that it wants to detect: “One of the really valuable things about CRISPR diagnostics is that it is rapidly developed and rapidly programmable.”