SAN JOSE, Calif. (Reuters) - Silicon Valley medical equipment startup Visby Medical has received Emergency Use Authorization by the U.S. Food and Drug Administration for a portable PCR COVID-19 test kit, the first company to do so, according to the FDA on Thursday.
PCR, or polymerase chain reaction, rapidly replicates DNA or RNA and is considered an accurate diagnostic 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.
Visby founder and CEO Adam de la Zerda started working at shrinking that machine to a portable size that fits in the palm over seven years ago, initially to use on diagnosing sexually transmitted diseases. But with COVID-19 the company pivoted.
The EUA allows Visby’s kit to be used in clinical labs. A sample taken via a nasal swab is inserted into the kit and produces results in 30 minutes. The company said the goal is to eventually get the test kit sold to consumers to use at home.
The kits are assembled at the company’s San Jose headquarters, where production capacity is around 50,000 a month. 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.”
U.S. officials have been pushing to increase the availability of COVID-19 diagnostic tests, particularly those that can be conducted cheaply from any location and quickly produce results.
A lack of testing capacity and little federal coordination early in the pandemic hampered efforts to control spread of the virus that has infected more than 6 million people in the United States.
Reporting by Jane Lanhee Lee and Nathan Frandino, Additional reporting by Carl O’Donnell, Editing by Rosalba O’Brien
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