FDA Approves Gene-Editing Tech For COVID-19 Tests

Updated May 13, 2020

The U.S Food and Drug Administration (FDA) has granted Sherlock Bioscience, a bioengineering company, Emergency Use Authorization (EUA) for COVID-19 diagnostic testing. The Sherlock™ CRISPR SARS-CoV-2 kit is sophisticated enough to detect a coronavirus infection in about an hour.

Co-founder, president and CEO of Sherlock Bioscience, Rahul Dhanda, commented on the significance of the FDA’s authorization in a recent press release, “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.” Elaborating on the rollout of the tests, he said, “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 this pandemic.”

The Challenge of Reliable Testing 

The novelty of the coronavirus has challenged medical science around the world and the rapid outbreak shortened the time necessary to collect samples and return results. Until now, testing relied on Reverse Transcription Polymerase Chain Reaction (RT-PCR), a conventional testing approach with fluctuating accuracy in detecting the unknown virus.

Now, all this uncertainty about results may have changed with the FDA’s approval of CRISPR technology. In a Washington Post article about the CRISPR solution, Feng Zhang, a leader of the research team and a co-inventor of CRISPR, explained that the test may offer new hope for accurate COVID-19 testing because the “test doesn’t require any complicated or expensive equipment.”

Although the FDA’s emergency authorization only allows testing in medical laboratories, Zeng believes that this is just the beginning stages of how the test will be used. Since the test is simple enough for nonprofessionals to administer, it has the potential for trained personnel in a workplace setting to screen employees.

Why the FDA Approved the CRISPR Testing Kit 

CRISPR, an acronym for Clustered Regularly Interspaced Short Palindromic Repeats, is a technology designed to identify mutated genes on a strand of DNA, cut them out, and replace them with functional genes.

This is the first time that Sherlock Bioscience has used CRISPR technology as a diagnostic tool. The technology gained worldwide recognition last year when researchers in China successfully edited out mutated genes in twins still in the womb.

Researchers at Harvard University, Massachusetts Institute of Technology, Howard Hughes Medical Institute, and the Ragon Institute hypothesized that the gene-editing technology could also be used to detect coronavirus in the human body. The evidence of the efficacy of this fresh approach convinced the FDA to grant the new test Emergency Use Authorization on May 7th.

How the CRISPR SARS-CoV-2 Works 

Unlike the Reverse Transcription Polymerase Chain Reaction tests, it is not necessary to convert genetic materials in a sample from RNA to DNA to run a test. RNA is the polymeric molecule necessary for coding, decoding, regulation, and expression of genes while DNA is the molecule with two polynucleotide chains that form a double helix to carry genetic instructions on how an organism should develop, function, grow, and reproduce. The CRISPR SARS-CoV-2 Kit can consistently detect the virus in the human body from the RNA. Researchers demonstrated the reliability of the test using synthetic COVID-19 samples in the laboratory.

What Is an Emergency Use Authorization? 

An Emergency Use Authorization does not mean that the FDA has thoroughly reviewed the tests, nor does it mean that it has fully approved the use of the test. What it means is that the test has passed rudimentary investigation and appears reliable enough to fill an unmet medical need in a national emergency.

It’s also important to note that CRISPR SARS-CoV-2 is not the only COVID-19 diagnostic test granted an Emergency Use Authorization. The FDA has given this authorization to more than 60 COVID-19 tests.

What’s different, however, about CRISPR SARS-CoV-2 is that it promises to be the best coronavirus test devised to date.

This diagnostic test offers the following benefits:

  • It is easy to get a tissue sample. Scientists can program a CRISPR molecule to detect the genetic signature of the coronavirus in a nasal swab or from a blood specimen.
  • It is reliable. The test does not provide any false negatives or false positives. After detecting a genetic signature, the CRISPR enzyme gets activated and releases a signal that shows that coronavirus has infected a person.
  • It only takes three steps to test someone. First, a tester collects a sample from a person and amplifies it with a polymerase amplification kit. Second, a lab technician incubates the sample and identifies the virus using an RNA editing technique called “Cas13.” Third, a paper dipstick is used to observe with the naked eye that the virus was only present in the sample.
  • It takes about an hour to run a test. The first step takes about 25 minutes, the second, 30 minutes, and the last, 2 minutes.

Future Development

Although the current test requires laboratory analysis, Sherlock Bioscience is working on making a single cartridge that would eliminate the need for laboratory testing to provide a result. After this refinement of the kit, it could be possible for individuals to test themselves at home.