FDA provides emergency authorization for the first-ever coronavirus test using the gene editing tool CRISPR
The U.S. Food and Drug Administration (FDA) has granted initial authorization for emergency use for a coronavirus test using the gene editing program CRISPR.
The team, which includes scientists from different institutions, says the test can detect if a patient has coronavirus in about an hour.
It works by using a molecule to search for the genes of the virus in a sample. When it finds the virus, the molecule is activated and releases a detectable signal that ‘glows’.
In addition, officials say the test detected coronavirus 100% of the time, meaning it did not yield false negatives.
Despite only being approved for emergency use, this is the first time the FDA has authorized a CRISPR device in patients.
The FDA has granted an emergency use authorization to redesign CRISPR gene editing technology, a coronavirus test. Pictured: Nurse Latasha Ivey delivers a nasal test at a coronavirus testing center on the Alabama State University campus in Montgomery, May 6
It uses a molecule that can find viral RNA instead of human DNA, in nose and throat samples, and glows when found. Pictured: Dr. Jose Gilberto Montoya took samples of nasal swabs as part of his research to develop an antibody coronavirus test in Palo Alto, California, April 29
A sous-vide water bath that incubates samples at 138 degrees because the samples need to be stored at a specific temperature
The test was developed by researchers from the Massachusetts Institute of Technology, Harvard University, the Ragon Institute and the Howard Hughes Medical Institute and is marketed by Sherlock Biosciences in Cambridge, Massachusetts.
CRISPR has sparked enthusiasm for its potential to correct genetic diseases, as well as alarm, after Chinese scientists revealed last year that he had genetically engineered twins in the womb.
The technology has remarkable possibilities: it can find certain genes along a strand of DNA, then cut out the defective piece and eventually replace it with a corrected version of the gene.
One of the leaders of the research team, Dr. Feng Zhang, is a molecular biologist who co-invented gene editing technology.
“CRISPR is ready and mature,” said Rahul Dhanda, Sherlock president and CEO Forbes.
“Not only do we validate and first prove the capabilities of Crispr of every therapeutic or diagnostic company, but it is also a solution to one of the biggest healthcare challenges of our lives.”
Dhanda said the company has focused on the technology to treat chronic and infectious diseases, but the focus of the entire company has shifted to coronavirus as the pandemic grew.
“I told everyone who worked for Sherlock that we will become a COVID-19 company until we have a solution that can make a difference,” he told Forbes.
The first step of Sherlock’s test requires a health professional to take a patient’s nose or throat swab.
Researchers then make multiple copies of the sample’s genetic material and store it at a specific temperature.
The next. a CRISPR molecule called Cas13 is added to the copies.
When the molecule finds RNA sequences, it breaks them down into small pieces that glow due to a fluorescent indicator.
Sherlock said that in 2,000 tests conducted before the FDA authorized emergency use, there were no false negatives. Pictured, from left to right: Sherlock Biosciences co-founders Omar Abudayyeh, Jonathan Gootenberg, Rahul Dhanda, Jim Collins and Pardis Sabeti
The team is also working on another test using CRISPR, but that would be a way to screen for the virus at home without sending a sample to a lab. It shows negative (left) or positive (right) results on paper strips similar to a pregnancy test
In the nearly 2,000 tests Sherlock performed before the FDA gave approval, the technology positively identified the virus 100 percent of the time.
That means there are no false negatives.
Sherlock says to partner with a partner to scale up production and will reveal plans to distribute the kits in the coming weeks.
The team is also working on another test using CRISPR, but that would be a way to screen for the virus at home without sending a sample to a lab.
All agents that respond to the sample can do so in one test tube, after which a paper dipstick shows the results, similar to how a pregnancy test shows results.
In theory, a person could put their own sample in a tube where it would mix with the CRISPR enzyme and the reagent, react and darken the positive or negative stripe on the paper strip.
In early tests, it also reacts with saliva, making the test even easier to take at home without risking exposure.
In laboratory experiments, the CRISPR test was found to be 97 percent sensitive – meaning it alone couldn’t identify coronavirus in samples where the virus was present – and 100 percent specific, meaning it never mistaken anything else for coronavirus.
This is consistent with the other available diagnostics for coronavirus.
“The ability to test for COVID-19 at home, or even in pharmacies or workplaces, can be a major challenge in getting people back to work and in their communities safely,” said Dr. Feng Zhang. STAT News.
“Creating a point-of-care tool is a critical goal to enable timely decisions to protect patients and their environment.”