NEW YORK – Sherlock Biosciences and Integrated DNA Technologies (IDT) said on Monday that they have entered into a collaboration for the large-scale manufacturing of Sherlock's CRISPR SARS-CoV-2 testing kits.
The kit, which detects the coronavirus that causes COVID-19 in patient samples, recently received Emergency Use Authorization from the US Food and Drug Administration. It is the first CRISPR-based diagnostic test to receive EUA for the detection of SARS-CoV-2. The kit provides specific and sensitive detection of the virus in patient samples, and it requires no specialized instruments.
The test provides results in approximately one hour. It's based on the SHERLOCK (Specific High-sensitivity Enzymatic Reporter unLOCKing) platform, one of the company's foundational platforms, which was 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.
The kit 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 (BAL) 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.
IDT is supporting the manufacturing of the kit by supplying key components such as the Cas13a nuclease as well as CRISPR RNA and primer mix. Financial terms of the deal were not disclosed.
"Given the severity and scale of the COVID-19 pandemic, it is imperative to increase and improve upon existing diagnostic solutions," Sherlock Bio Cofounder, President, and CEO Rahul Dhanda said in a statement. "We are pleased to partner with IDT, a leading comprehensive genomics solution provider. They have already been leading the charge in large-scale manufacturing of key components for the CDC EUA testing protocol to meet the demands of this global pandemic, and this is another avenue in which they are supporting testing needs. Through this strategic partnership, we will be able to scale production as needed to satisfy the demand for increased testing volumes, which should allow laboratory technicians to run tests at a higher throughput and provide results rapidly to improve patient care."