NEW YORK – Sherlock Biosciences said today that it has received a $5 million grant from the Bill & Melinda Gates Foundation to continue the development of its synthetic biology-based INSPECTR molecular diagnostics platform.
INSPECTR (Internal Splint-Pairing Expression Cassette Translation Reaction), one of the firm's foundational technologies, uses synthetic biology to enable the creation of instrument-free diagnostic tests that can be conducted at home, at room temperature. INSPECTR can be adapted to work on a paper strip test similar to a pregnancy test, or to provide an electrochemical readout that can be read with a mobile phone. It can also be adapted for use in laboratory or point-of-care settings, Sherlock Bio said.
The company plans to use the new funding from the Gates Foundation to improve the sensitivity of the INSPECTR platform, and to develop an over-the-counter disposable product that can be used to detect SARS-CoV-2, Sherlock Bio Chief Technology Officer William Blake said in a statement. The firm is on track to launch the product in mid-2021, pending regulatory approval.
Sherlock Bio first said at the end of February that it had been developing and testing a series of assays for SARS-CoV-2 using its other foundational technology — the SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) platform, which was first developed by Feng Zhang's team at the Broad Institute in 2017. SHERLOCK combines various CRISPR-Cas enzymes such as Cas13, Cas12a, and Csm6 to allow for the simultaneous detection of multiple nucleic acids.
In May, Sherlock Bio said it had received Emergency Use Authorization from the US Food and Drug Administration for its Sherlock CRISPR SARS-CoV-2 kit, which works by programming a CRISPR molecule to detect the presence of a genetic signature specific to SARS-CoV-2 in a nasal swab, nasopharyngeal swab, oropharyngeal swab, or broncho-alveolar lavage specimen. When the signature is found, the CRISPR enzyme releases a detectable signal. The test is designed for use in high-volume CLIA laboratories and hospitals.
And in July, the company announced it was partnering with Binx Health to develop a CRISPR-based rapid, point-of-care diagnostic test for COVID-19. The companies plan to combine the Binx io diagnostic platform with SHERLOCK to create a rapid and accurate test for use in CLIA-waived settings such as clinics, doctors' offices, assisted living centers, pharmacies, and other easily accessible consumer venues.
At the time of the Binx deal, Sherlock Bio Cofounder, President, and CEO Rahul Dhanda told GenomeWeb that the INSPECTR-based test was originally further behind in development than the SHERLOCK-based assay because the original estimates for the pandemic was that it would be over sometime in the late spring. When the pandemic continued to stretch further into the year, the company changed its thinking in the applicability of INSPECTR to SARS-CoV-2 testing.
"We first thought at-home was best and we certainly focused on that," Dhanda said. "But a lot of interest in the technology is also suggesting other areas. We can have a big impact, from low-resource settings to employee testing."
Indeed, low-resource settings seem to be a particular focus for INSPECTR-based tests. "By creating the very first diagnostic tests that do not require complex instruments and can be deployed anywhere, especially in low-resource settings, Sherlock is poised to make a wide-ranging and powerful impact on health outcomes," James Collins, cofounder and board member of Sherlock Bio and professor of medical engineering and science at MIT, said in a statement regarding the new grant. "We are delighted by the support of the Gates Foundation to develop these tests, which we believe will contribute to earlier disease detection, faster intervention, and the elimination of epidemics worldwide."