FDA Approves Portable Handheld PCR COVID-19 Test

The machine has been in development for over seven years.

Screen Shot 2020 09 18 At 6 07 33 Pm

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.


See it Live at PACK EXPO Connects Nov. 9-13: Pharmaceutical Multipacking Solutions, by Polypack, Inc. Preview the Showroom Here.


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. 

More in Quick Hits