The FDA granted its first-ever emergency use authorization for the gene-editing technology Crispr—greenlighting a coronavirus diagnostic test developed by Cambridge, Massachusetts-based Sherlock Biosciences
, Sherlock has raised more than $50 million, including $32 million in equity and $20 million in non-diluted funding, focusing on diagnostic applications of Crispr technology for infectious and chronic diseases, according to Dhanda.
The first step for Sherlock’s test is taking a patient sample — from the nose or throat or lungs — and making many copies of the genetic material while keeping them at a certain temperature. Then a Crispr molecule, a protein complex known as Cas13, is added to those sample copies. If any RNA sequences from the SARS-CoV-2 coronavirus are present in the sample, it latches on and starts cutting them off into smaller pieces, some of which are tagged with a fluorescent marker.
This is where the company’s tech comes in. “Sherlock” isn’t just a reference to literature’s greatest detective — it’s an acronym for Specific High-sensitivity Enzymatic Reporter unLOCKing. In the nearly 2,000 tests Sherlock ran in order to satisfy the FDA’s requirements for the authorization, its technology was able to identify the presence of SARS-CoV-2 100 percent of the time, the company says. But those tests were all run on known true positive and true negative coronavirus samples.
Sherlock is currently working with an undisclosed partner on scaling up access to its diagnostic tests at high volume, and Dhanda expects to make an announcement on that rollout in the coming weeks. The company is also working on another test called INSPECTR, which people would be able to use in their homes, rather than in a lab setting. That synthetic biology-based product would be able to provide users a positive or negative result on a strip of paper.
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