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FDA Approves Portable Handheld PCR COVID-19 Test

The machine has been in development for over seven years.

According to a recent Reuters article, the FDA granted Emergency Use Authorization to the first portable PCR COVID-19 test kit. The test comes from Silicon Valley startup Visby Medical. Founder and CEO Adam de la Zerda began working on a handheld PCR testing machine over seven years ago with the intention of diagnosing sexually transmitted diseases. Like many companies, he decided to pivot with the outbreak of COVID-19.


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The kits are manufactured at the company’s HQ in San Jose, where their production capacity is roughly 50,000 units a month. Nasal swabs are collected and then inserted into the kit, and results are available within 30 minutes. Visby hopes to eventually sell the test kits to consumers at home, but for now they’ll be used in clinical labs. 

Explore new technology from hundreds of life sciences suppliers.
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Explore new technology from hundreds of life sciences suppliers.
New food packaging & processing solutions, all at PACK EXPO in Chicago
Experience the cutting edge of food packaging and processing innovation at PACK EXPO International this November. See machinery and equipment in action, discover new technologies, and learn sustainable solutions from experts, all in one place.
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New food packaging & processing solutions, all at PACK EXPO in Chicago