Israel will be the first country in the world to try out an experimental new coronavirus test that promises to deliver a diagnosis within 23 minutes, the defense minister said Sunday.
If the device proves successful, Defense Minister Benny Gantz said, it will allow the government to “reopen the economy and the education system.”
“An important update from the battle against the coronavirus,” Gantz tweeted on Sunday. “After months of work by the defense establishment, in the coming days the Biological Institute will receive quick-test kits that will provide an answer in 23 minutes.”
He added: “The kits by Visby Medical received approval last week from the American FDA, will undergo a flash examination at the Biological Institute, and then the necessary process in the Health Ministry, in an effort to provide immediate tests that will help us reopen the economy and the education system.”
The device has won temporary “emergency use” approval from the US Food and Drug Administration, and remains experimental.
In a press release in mid-September, the California-based Visby Medical announced it had obtained “emergency use authorization,” a type of approval described by the FDA as intended to “help strengthen the nation’s public health protections against CBRN [chemical, biological, radiological and nuclear] threats by facilitating the availability and use of MCMs [medical countermeasures] needed during public health emergencies.”
US law permits the FDA to allow “unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.”
According to Gantz, the new test will allow the government to “quickly and on a daily basis test medical teams, old age homes, suspected outbreaks in schools, workers at vital factories, and other situations.”
Science Minister Izhar Shay connected Visby with the Defense Ministry, Gantz said.
“We will continue to do everything we can to fight the pandemic and restore our lives to their old routine,” he added.
The test device is “PCR-based,” a technique that replicates the genetic material of the pathogen in a test sample to more easily identify the virus even in a sample with a small amount of the pathogen.
“Through controlled heating and cooling of sample material in the presence of specially designed enzymes, billions of copies of target genetic material are created,” the company explained in a public statement.
“Without this amplification process, a sample with a small viral load — such as from an asymptomatic carrier of COVID-19 — would go unnoticed. This is why PCR is considered the gold standard in diagnostic testing; it is maximally specific and highly sensitive, and hence it offers the best chance of finding a pathogen.”
The process is considered reliable and accurate, the company says, and the new device marks the first time it has been miniaturized into a rapid diagnostic tool.
“By eliminating the long lead time to results and integrating the entire PCR process into one machine, Visby’s invention could vastly expand the possible use cases for PCR test results. The need for such accessibility has been abundantly clear since the earliest days of the pandemic, especially in light of the limitations of turn-around time inherent to lab-bound PCR.”
In the US, the approval of the device for emergency use “is limited to authorized laboratories,” the company said. Israeli officials have not indicated how the device would be deployed or what approval it is likely to obtain in Israel.