Cambridge-based Sherlock Biosciences made history Thursday by developing the first CRISPR-based coronavirus diagnostic kit to be authorized for emergency use by the U.S. Food and Drug Administration. In short, the test will be administered by healthcare professionals in a CLIA-certified lab and can detect the virus in about one hour.
CRISPR is the product of research done by Feng Zhang of the Massachusetts Institute of Technology and Harvard University’s Broad Institute and MIT professor Jim Collins, both of whom are among Sherlock Bioscience’s nine founders. Ordinarily the technology is used to slice into a strand of DNA and replace faulty genes associated with various diseases, and has been used in several small studies aiming to treat conditions including sickle cell diseases and beta thalassemia. Sherlock Bioscience has been using the technology for about a year now to diagnose infectious and chronic diseases.
The SHERLOCK (short for Specific High-sensitivity Enzymatic Reporter unLOCKing) coronavirus test doesn’t alter the patient’s genes. Instead, once a sample is collected from the nose, throat or lungs, many copies of the genetic material are made and kept at a certain temperature. Then, a CRISPR molecule is added to those sample copies. If the genetic signature for SARS-CoV-2 — the virus that causes COVID-19 — is detected in the sample, then the molecule will latch on and tag it with a fluorescent marker, which will cause the sample to glow, according to Forbes. The process takes about an hour, according to Sherlock Bioscience. The company also says it is in the midst of developing a platform called INSPECTR to create an “instrument-free, handheld test — similar to that of an at-home pregnancy test” as another means of rapidly testing for the novel coronavirus.
“When our lab collaborated with Dr. Feng Zhang’s team to develop SHERLOCK, we believed that this CRISPR-based diagnostic method would have a significant impact on global health,” Collins said in a statement. “During what is a major healthcare crisis across the globe, we are heartened that the first FDA-authorized use of CRISPR will aid in the fight against this global COVID-19 pandemic.”
It is worth noting that FDA emergency use authorizations allow unapproved medical and diagnostic products to be used to help solve a specific public-health emergency like the one we are facing right now, but it is not the same as an FDA approval. That being said, the Boston Business Journal reports that Sherlock Bioscience tested its technology on more than 1,500 positive and negative samples and underwent a “dynamic and communicative review process with the FDA.”
The company says it is working to “rapidly scale” production of its test kit with an undisclosed Massachusetts company and will share plans for distribution and availability in the coming weeks.
“While it has only been a little over a year since the launch of Sherlock Biosciences, today we have made history with the very first FDA-authorized use of CRISPR technology, which will be used to rapidly identify the virus that causes COVID-19,” the company's co-founder, president and CEO Rahul Dhanda said in a statement. “We are committed to providing this initial wave of testing kits to physicians, laboratory experts and researchers worldwide to enable them to assist frontline workers leading the charge against the pandemic.”
