CRISPR gets its first FDA authorization with a COVID-19 test

The U.S. Food and Drug Administration has granted Emergency Use Authorization to a COVID-19 test that uses controversial gene-editing technology CRISPR.

This marks the first time CRISPR has been authorized by the FDA, although only for the purpose of detecting the coronavirus, and not for its far more contentious applications. The new test kit, developed by Cambridge, Massachusetts-based Sherlock Biosciences, will be deployed in laboratories certified to carry out high-complexity procedures and is “rapid,” returning results in about an hour as opposed to those that rely on the standard polymerase chain reaction method, which typically requires six hours.

CRISPR technology derives from the natural defense mechanisms of bacteria and archaea, which allow these organisms to recognize foreign invaders, such as viruses, and then destroy them by slicing and dicing their genomes. In Sherlock’s COVID-19 test, CRISPR molecules are programmed to recognize SARS-CoV-2’s genetic signature within a nasal swab sample, and release signals upon detection.

“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,” said James J. Collins, a Massachusetts Institute of Technology professor and cofounder of Sherlock Biosciences, in a statement.

While COVID-19 tests are universally welcomed by the human race, CRISPR’s other uses have met resistance. The technology holds tremendous potential for gene editing, which could eradicate gene mutation diseases such as sickle cell anemia or Huntington’s. However, it also opens Pandora’s box as far as people-editing goes. In 2018, a Stanford University-trained scientist in China shocked the world by revealing that he’d created the first genetically modified “designer babies,” in a furtive “illegal medical practice” that landed him in prison.

Controversies aside, CRISPR could be a powerful tool in combating the COVID-19 pandemic, as widespread testing has been acknowledged as key in containing the coronavirus. In a press release, Sherlock Biosciences said it’s working on an equipment-free CRISPR-based COVID-19 test, which would involve adding just a few drops of liquid to a test tube and cost just $6 to run.