FDA greenlights Visby Medical's single-use, portable PCR test for COVID-19

Visby Medical received a new emergency authorization from the FDA for its rapid, single-use PCR test designed to detect COVID-19 infections at the point of care.

The entire test is contained on a small, palm-sized device that plugs into a power outlet. After a patient’s swab sample is mixed with reagents and diluted in a test tube, the fluid is placed into the reader. It’s designed to deliver a result three buttons and 30 minutes later.

The portable diagnostic was first granted an FDA green light last September, as the San Jose, California-based company exited stealth mode; the latest authorization allows the test to be used outside of the laboratory setting and by healthcare professionals on the front lines of the pandemic.

By miniaturizing PCR technology, Visby hopes to provide a gold-standard molecular test for COVID-19, but in an accessible form factor similar to rapid antigen tests that may have lower sensitivity.

“Medical professionals and the communities they serve have been forced to abide by the idea that accuracy comes at the cost of speed,” said Visby’s founder and CEO, Adam de la Zerda. 

“Even in the face of an available vaccine, a rapid PCR test is an important tool to create COVID-free zones and establish operational continuity for businesses and critical infrastructure,” de la Zerda added. The company also said it is developing the diagnostic for testing combined pools of samples simultaneously.

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Earlier this month, Visby partnered with the U.S. government’s Biomedical Advanced Research and Development Agency, known as BARDA, to develop the portable test to detect both the coronavirus and influenza A and B, and have it potentially available over-the-counter. That project included a $12.3 million award, which may be extended up to a total of $48.7 million over three years.

Visby has also secured $10 million in manufacturing scale-up funding from the National Institutes of Health, through its competitive diagnostic accelerator program.