Visby Medical announced today that it received FDA emergency use authorization (EUA) for its rapid COVID-19 test at point-of-care.
San Jose, Calif.-based Visby’s rapid PCR COVID-19 test received EUA previously but can now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver, according to a news release.
Visby’s testing device has palm-sized dimensions and eliminates the need for an additional instrument or reader so that it can provide fast, accurate results at the point of care, requiring only a power plug. Additionally, Visby said it has the potential capability to run pooled tests in the future.
“This latest authorization will have a significant impact on COVID-19 testing, especially in situations when an accurate result is needed quickly,” Visby chief medical officer Dr. Gary Schoolnik said in the release. “Visby’s test can now be used directly at the point of care with our most vulnerable populations, including nursing homes, frontline health workers, to maintain patient care at places like cancer and dialysis treatment centers, and to the many schools and institutions that have undertaken the process to become CLIA-waived environments.”
“Medical professionals and the communities they serve have been forced to abide by the idea that accuracy comes at the cost of speed,” added founder & 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.
“Our innovative technology has been tested, reviewed and endorsed by leading academics and health care researchers.”