A research company has gotten FDA approval to begin using its CRISPR-based COVID-19 test, which promises to be faster and easy to perform without access to a full lab.
Current coronavirus testing is based on PCR (polymerase chain reaction), the same technology used in DNA tests. This involves repeatedly heating the sample to amplify the genetic material so technicians can detect viral RNA.
CRISPR/Cas9 has gained fame as a powerful tool for genetic engineering, but that’s slightly different than the system devised.
CRISPR is the sequence that guides Cas9 to the specific genetic code where you want to make a cut (known as cleaving), but scientists can also pair CRISPR with other members of the Cas family.
This system uses a related enzyme called Cas13 that doesn’t just cleave the specified sequence, when CRISPR activates Cas13, it cleaves any RNA it touches in a process called collateral cleaving. Some of that genetic material will be in the reporter molecule, and that’s how you detect disease.
In a sample positive for coronavirus, the CRISPR sequence will detect the virus’ genetic material and activate Cas13. This leaves plenty of sliced up reporter molecules in the sample, but a negative test would have all intact reporters.
This marks the first time a CRISPR-based tool has gotten any regulatory approval for use in humans.