Visby's COVID-19 test gets FDA approval
A portable COVID-19 test has been given emergency authorization for use by the U.S. Food and Drug Administration.
According to the FDA Thursday, Silicon Valley startup Visby Medical is the first company to get emergency approval, allowing its test kit to be used now in clinical labs.
U.S. officials have been pushing to increase the availability of tests, particularly those that can be conducted cheaply from any location and quickly produce results.
Visby's test produces results in as little as 30 minutes -- with the stated goal of eventually being sold to consumers for use at home.
Visby founder and CEO Adam de la Zerda explains:
"Of course, you need first collect the nasal swab and once you do, the sample goes into here. Once you put the sample in here, you close the lid. Now you need to press the three buttons, one, two and three in this order and now you just have to plug the device to the wall from the back (with) a small power adapter we give you and the thing starts running. One line telling you you're negative. Two lines means you're positive, just like reading a result from a pregnancy test."
Visby's device is what's called a PCR, or polymerase chain reaction, test.
It rapidly replicates DNA or RNA - and it's considered an accurate diagnostic tool used in infectious diseases labs.
PCR testing usually uses a machine the size of a large microwave and can cost hundreds of thousands of dollars.
De la Zerda started working at shrinking that machine to a portable size fitting in the palm of your hand over seven years ago, initially for diagnosing sexually transmitted diseases.
But with the outbreak of COVID-19 around the world, the company quickly pivoted.
A lack of testing capacity early on in the pandemic hampered efforts to control its spread in the U.S., infecting more than 6 million Americans.
Dr. Gary Schoolnik, Visby's Chief Medical Officer:
"When you have a test that provides that kind of rapid testing capability, you're able to make decisions rapidly, communicate them to the patient. It means that patients will get the best possible care."
Visby currently produces around 50,000 test kits a month, and the pricing has yet to be decided.
But the company, which has raised over $300 million from investors so far, hopes to ramp up its production to bring the cost down.
