Silicon
Valley startup Visby's portable COVID-19 test gets FDA
approval
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[September 18, 2020]
By Jane Lanhee Lee and Nathan Frandino
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.
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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."
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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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