Rapid, single-use PCR coronavirus test authorized by FDA

A rapid, single-use PCR test made by San Jose, Calif.-based diagnostics company Visby Medical, received FDA authorization Feb. 10 to be used in a wide range of facilities, including urgent care clinics, pharmacies and universities. 

Visby Medical said the test may be used by any organization with a waiver from the FDA that allows tests to be conducted without a laboratory technician. Such places can include schools, airports and businesses. 

PCR tests, or polymerase chain reaction tests, are known as the "gold standard" of lab tests because they are highly accurate, but they often take longer to get results than rapid tests as they typically must be sent to a lab. 

Visby Medical said its portable, single-use PCR device eliminates the need for an additional instrument or reader to get results. 

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

Read the full news release here


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