The first single-use, highly accurate rapid coronavirus test has received the all-clear from the Food and Drug Administration to be used in a wide variety of settings, per its manufacturer, Visby Medical.
Why it matters: Even with vaccines, widespread coronavirus testing is still essential for safely returning to normal life.
The big picture: Many rapid tests aren't as reliable as gold-standard PCR tests, but PCR tests can take days to process and require expensive equipment.
What they're saying: "This is the first time that anyone has been able to take this gold-standard laboratory equipment…and put it in a [form] that anyone can just carry in their hand," Visby CEO Adam de la Zerda said.
- “The fact that it's single use means you don’t have to worry about an instrument and you have unlimited testing capacity," he added. Results take only 30 minutes.
State of play: The FDA authorized the PCR test for use in labs and hospitals a few months ago. This week, the agency said the test can be used in places like airports, schools and businesses, as long as they've received a waiver from the FDA requirement that tests be run by a laboratorian.
- The company is producing tens of thousands of tests a month, but is "anticipating to start scaling to the hundreds of thousands of devices per month, and work our way up from there," de la Zerda said.
- He said the hope is for the tests to eventually be accessible for at-home use, and beyond that, for the technology to be used for other diseases as well.
