During a public health emergency, the U.S. Food and Drug Administration (FDA) has the authority to accelerate the approval process for medical tests and new drugs. That authority has now been exercised for the first CRISPR-based SARS-CoV-2 test. The test will now be made available to laboratories in the United States that are certified to provide clinical test results.
The United States, like many other countries battling COVID-19, has struggled to test sufficient numbers of people to determine if they have been infected with the 2019 Novel Coronavirus SARS-CoV-2. The U.S. has been conducting around 250,000 tests a day, and while some areas have sufficient tests available, there are many areas that have a shortage of tests. The new CRISPR-based test could help to address the shortfall.
The new test was developed by the biotechnology firm Sherlock Biosciences using an approach devised by Feng Zhang of the Broad Institute of MIT and researchers at Harvard University. The MIT researchers first described a CRISPR-based test in 2017 and in 2018, a team of MIT researchers showed that their CRISPR approach could be used in diagnostic tests for the Zika virus and Dengue virus.
Sherlock Biosciences programmed CRISPR to bind to a specific genetic sequence present in the RNA of SARS-CoV-2. If CRISPR identifies that sequence and binds to the RNA it generates a fluorescent glow that can be detected. The test is used to analyze samples from nose, mouth, and throat swabs and will take an hour to give a result, making it one of the quickest diagnostic tests for SARS-CoV-2 now in use. The company is now working on developing a version of its test that could be used by patients in their own homes, although a home-based test would need a separate FDA authorization before it could be used.
While the CRISPR-based test has been shown to be effective, it is unclear whether it will prove to be as effective as the tests currently being used to diagnose patients in hospitals.