First-Ever FDA-Authorized CRISPR-Based Rapid Diagnostic Test Kit to Be Launched

Sherlock Biosciences (Cambridge, MA, USA) and Integrated DNA Technologies {(IDT) Coralville, Iowa, USA} have entered into a strategic collaboration to enable large-scale manufacturing of the Sherlock CRISPR SARS-CoV-2 kit for the detection of the novel coronavirus.

The test kit, for which Sherlock Biosciences recently received Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA), will assist in managing the COVID-19 pandemic by increasing testing capacity and decreasing time to result. The Sherlock kit is the first CRISPR-based diagnostic test to receive EUA for the detection of SARS-CoV-2. Based on the SHERLOCK method, which stands for Specific High-sensitivity Enzymatic Reporter unLOCKing, the kit works by programming a CRISPR molecule to detect the presence of a specific genetic signature – in this case, 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 releases a detectable signal.

The kit provides specific and sensitive detection of the virus in patient samples, and requires no specialized instruments to complete a test. Using standard laboratory equipment gives it a minimal footprint and contributes to a turnaround time of approximately one hour, significantly faster than other testing methods. IDT is supporting the manufacturing of the kit by supplying several key components, including the Cas13a enzyme on which the test is based, as well as CRISPR RNA (crRNA) and primer mix. IDT’s product quality, speed, and ability to scale are key factors in helping to bring the Sherlock kit to market.

“Given the severity and scale of the COVID-19 pandemic, it is imperative to increase and improve upon existing diagnostic solutions,” said Rahul Dhanda, co-founder, president and CEO of Sherlock Biosciences. “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.”

“Sherlock has developed a unique methodology for quick and specific detection of SARS-CoV-2, and IDT is proud to leverage our high-quality products to support this groundbreaking testing method,” said Trey Martin, president of IDT. “We look forward to working closely with Sherlock to scale the production of its CRISPR test kit to meet demand in response to this global pandemic.”

Related Links:
Sherlock Biosciences
Integrated DNA Technologies