FDA approves Visby’s portable Covid-19 PCR test kits for emergency use

The U.S. Food and Drug Administration on Thursday granted emergency use authorization for a portable Polymerase Chain Reaction (PCR) Covid-19 test kit made by Visby Medical, a company founded by Israeli entrepreneur Adam de la Zerda. The company’s palm-sized kit provides reliable results within 30 minutes.

Zerda, a computer engineering graduate of the Technion - Israel Institute of Technology - founded the company in 2013 and currently serves as its CEO. The company had been working on developing a personal disposal PCR kit to rapidly test for various infectious diseases but said its first commercial application came about as part of the battle against the spread of Covid-19.

Visby said it is prepared to expedite the production and distribution of its kits and is signing partnership agreements with governments and private companies in order to accelerate their path to market.

PCR is a process of exponentially replicating DNA or RNA. It works by controlled heating or cooling of samples in the presence of specially designed enzymes, creating billions of copies of the desired genetic material. Without the replicating process, samples with a small viral load, such as those collected from an asymptomatic Covid-19 carrier, would not be detected. For that reason, PCR is considered a mandatory standard in tests meant to provide a diagnosis. It is extremely specific and sensitive and therefore provides the best chances of detecting the pathogen.

“We are excited by the FDA’s decision. The Covid-19 crisis proved we require accurate test results provided quickly and that’s why PCR is the right way to conduct tests for coronavirus. We are glad that Visby’s personal PCR kits will now provide quick and accurate testing for the lab workers who are on the front line of battling the pandemic,” Adam de la Zerda said.

“The infectious disease testing market is a $40 billion market, which has been led for the past 25 years by PCR. Visby is revolutionizing the PCR world in the same way the smartphone revolutionized the world of computing, with a disposable, palm-sized device that is simple, fast, and accurate, which allows you to rapidly carry out the test anywhere, with maximum precision,” said Itay Harel, managing partner at Pitango Health, which led the third investment round in the company.