The kit will be designed and manufactured by GSK Consumer Healthcare. GSK already sells toothpaste, nicotine gum, and over-the-counter medicines to consumers.
CRISPR is best known as the gene-editing tool used to modify animals or correct genetic disease. But it can also be employed in diagnostic tests because it is able to zero in on very specific genetic information—like the genetic sequence of a virus—and then trigger a visible signal, similar to the bars that appear on a home pregnancy test.
The pandemic has added propellant behind the idea of using CRISRP for testing. That’s because the technology has features that make a portable test feasible: it is quick, requires little machinery, and works on raw samples like spit or snot.
“It’s the ultimate use case for CRISPR,” says Trevor Martin, the CEO of Mammoth. “Our vision is that it would be in the format of a pregnancy test.”
Right now, the most accurate covid-19 tests are molecular tests run in central labs, typically employing a technique called PCR, which requires several processing steps. The aim of companies like Mammoth is to skip PCR, making the costly equipment and trained technicians unnecessary.
“You want to make the type of testing you are doing at home the same level of accuracy as in a lab,” Martin says. “You don’t want a trade-off, and that has not been possible so far.”
In April, University of California researchers working with Mammoth demonstrated that CRISPR could spot the coronavirus. So did two other diagnostics companies working with the technology, Sherlock Biosciences and Caspr Biotech. “Getting a product to market is not about demonstrating the technology works. That took us a day,” Rahul Dhanda, CEO of Sherlock, said during an interview in March.
His company later won emergency approval to sell a lab-only version of its CRISPR test, although it’s still not in use.
It’s unclear how much home tests would really do to control the pandemic or limit new infections. An analysis by Imperial College found that regular covid-19 screening should be used with high-risk groups—say, to test health-care workers every week. That analysis saw less benefit for testing the population as a whole over just asking people with symptoms to self-quarantine.
If people test at home, they might not report the results to health authorities, limiting visibility into the spread of the pandemic. Without a doctor involved, they also might not get or follow medical advice about quarantining or alerting contacts.
“Providing home-based tests to individuals without a component of required reporting means missing potentially critical public health information,” says Donald Thea, a professor of global health at Boston University.