A new portable, palm-sized PCR Covid-19 test kit which provides results within 30 minutes has been granted emergency authorisation by the US Food and Drug Administration (FDA), making it the first time such a device has been approved in the United States.
PCR, or polymerase chain reaction, rapidly replicates DNA or RNA and is considered to be a speedy and accurate tool used in labs for infectious diseases.
Traditionally, PCR testing uses a machine the size of a large microwave and can cost hundreds of thousands of dollars, making this recent development a potential game-changer in the fight against Covid-19 as countries across the globe scramble to ramp up testing capacity.
The test kit, which was developed by a Silicon Valley medical startup called Visby Medical, involves a sample taken via nasal swab which is then inserted into the kit, and features LED lights that indicate the test is running and alerts when it is completed.
While the emergency authorisation only allows the kit to be used in clinical lab settings, the company said that its goal is to eventually get the kits sold to consumers to use at home.
Visby founder and CEO Adam de la Zerda started working on shrinking the technology to a portable size that fits in the palm over seven years ago, initially to use on diagnosing sexually transmitted diseases. When the Covid-19 pandemic hit, however, the company pivoted.
The kits are assembled at the company’s San Jose headquarters, where production capacity is currently around 50,000 a month, but Visby has said it wants to ramp that up to bring the cost down.
De la Zerda said pricing on the kit has not yet been decided, but he is aiming to make it “affordable.”
The company counts Nobel physics prize winner Steven Chu and Silicon Valley venture capitalist John Doerr as investors and has raised over $300 million so far.
“If you think very differently about this type of testing, this PCR testing, which is the gold standard, it can really transform things,” said Chu.
“The idea... you can get the answer in 15 to 20 minutes, that could be as reliable, or in fact even more reliable than the big machine standard testing, I think has become a reality.”
Adam de la Zerda said: “We are excited by the FDA’s decision. The Covid-19 crisis proved we require accurate test results provided quickly and that’s why PCR is the right way to conduct tests for coronavirus.
“We are glad that Visby’s personal PCR kits will now provide quick and accurate testing for the lab workers who are on the front line of battling the pandemic.”