NEW YORK – Genetic engineering company Sherlock Biosciences and Dartmouth-Hitchcock Health (D-HH), an academic health system based in New Hampshire, said on Wednesday that they are partnering to launch a clinical study of the Sherlock CRISPR SARS-CoV-2 kit.
The kit, which received Emergency Use Authorization from the US Food and Drug Administration in May, will be used to test clinical samples from patients at D-HH member hospitals. The kit is based on the SHERLOCK (Specific High-sensitivity Enzymatic Reporter unlocking) method and works by programming a CRISPR nuclease to detect the presence of the genetic signature for SARS-CoV-2 in a nasal swab, nasopharyngeal swab, oropharyngeal swab or bronchoalveolar lavage (BAL) specimen. When the signature is found, the CRISPR enzyme is activated and cuts reporter RNAs provided as part of the kit to release a detectable signal, yielding results in about an hour.
It is the first and, until now, the only CRISPR-based diagnostic test to receive EUA from the FDA for the qualitative detection of nucleic acid from SARS-CoV-2, Sherlock Bio said. It was designed for use in high-complexity CLIA laboratories.
"RT-PCR tests have been a mainstay in testing for the global COVID-19 pandemic in the US. Unfortunately, the sheer volume of tests demanded by the pandemic, coupled with the dwindling supply of reagents and other consumables needed to conduct RT-PCR, has created a dire need for alternative testing methods," Gregory Tsongalis, vice chair for research and director of the Laboratory for Clinical Genomics and Advanced Technology at D-HH, said in a statement. "We are excited to partner with Sherlock to understand how the company's novel CRISPR-based test may help circumvent some of the challenges with RT-PCR testing."
The team will be sharing preliminary results of the study as soon as they're available, he added.