FDA Approves First Covid-19 Test That Uses CRISPR Gene-Editing

Advanced scientific tools that might otherwise have undergone years of testing before approval are now being fast-tracked.

There will likely be some unintended consequences, but given the urgent need for diagnostics, the policy decision appears to be that any credible scientific approach which could help reduce illness and death is worth exploring. JL

Christine Fisher reports in Engadget:

The  CRISPR SARS-CoV-2 test uses a CRISPR molecule to detect the genetic signature of the virus. If it finds the virus, the CRISPR enzyme is activated, and that releases a detectable signal. The kit, which uses a nasal swab, is designed for use in laboratories authorized to perform high complexity tests. Precision, coupled with its capability to be deployed to multiplex over 100 targets or as a simple point-of-care system, will make it a critical addition to the arsenal of rapid diagnostics
Sherlock Biosciences has received an Emergency Use Authorization (EUA) from the FDA for a rapid COVID-19 test that uses CRISPR technology. This is the first FDA-authorized use of the gene-editing tool, which poses both massive potential and ethical issues. 

Sherlock’s CRISPR SARS-CoV-2 test uses a CRISPR molecule to detect the genetic signature of the virus. If it finds the virus, the CRISPR enzyme is activated, and that releases a detectable signal. The kit, which uses a nasal swab or bronchoalveolar lavage (BAL) specimen, is designed for use in laboratories authorized to perform high complexity tests. While it’s considered a “rapid” test, Sherlock did not say how long it takes to process the results.

“Sherlock enables rapid identification of a single alteration in a DNA or RNA sequence in a single molecule,” said Sherlock Biosciences co-founder David Walt. “That precision, coupled with its capability to be deployed to multiplex over 100 targets or as a simple point-of-care system, will make it a critical addition to the arsenal of rapid diagnostics already being used to detect COVID-19.”

Sherlock says it is working to rapidly scale production and will share plans for kit distribution and availability in the coming weeks. The company is also working on another handheld test, similar to that of a home pregnancy test, to detect COVID-19.

Sherlock’s CRISPR test is one of a growing number of FDA EUAs issued recently to address the coronavirus pandemic. The FDA has given the fast-tracked approval to NASA’s ventilator design and Formlabs’ 3D-printable attachment that turns sleep apnea BiPAP machines into ventilators. We will likely see more EUAs in the coming weeks.