02/02/2021 • Press Release
Visby Medical’s COVID-19 PCR Point of Care Test Authorized for Use in CLIA Waived Settings
Expanding critical access to the only single-use, rapid PCR test, at the point of care.
(San Jose, CA) – Visby Medical™ announced today the US Food and Drug Administration (FDA) authorized Visby’s rapid PCR COVID-19 test for use at the point of care (POC). Building on the FDA’s emergency use authorization granted earlier this year, Visby Medical’s rapid PCR COVID-19 test may now be used by any organization with a Clinical Laboratory Improvement Amendments (CLIA) certificate of waiver.
As the United States and the world confront another surge in COVID-19 cases, it is imperative that the best tools are available to fight infection, protect the most vulnerable and maintain essential operations. PCR testing has been acknowledged as the gold standard for its high level of accuracy, but has drawbacks including the reliance on centralized labs and long lead times for results.
By shrinking rapid PCR technology to palm-sized dimensions and eliminating the need for an additional instrument or reader, Visby Medical’s test provides fast, accurate, and actionable results at the point of need. What’s more, the Visby device is easy to use, with the potential capability of running pooled tests in the future. Requiring only a power-plug, the Visby test can be used virtually anywhere in the U.S. and will have a significant impact on rural communities without access to testing.
“This latest authorization will have a dramatic impact on COVID-19 testing, especially in situations when an accurate result is needed quickly,” said Dr. Gary Schoolnik, Chief Medical Officer at Visby Medical and Professor of Medicine at Stanford University specializing in infectious diseases. “Visby’s test can now be used directly at the point of care with our most vulnerable populations, including nursing homes; for 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.”
Founded by leading scientists in infectious diseases and diagnostics, Visby Medical has been working to change the order of diagnosis and treatment of infectious disease for the last decade. Enabling health professionals to carry out rapid diagnostics before treatment is Visby’s top priority and a mission equally critical to addressing COVID-19 and future pandemics. Even with the welcome announcement of COVID-19 vaccines, accurate and rapid testing will remain vital, as it will take time to vaccinate the US population and develop herd immunity.
Adam de la Zerda, Founder and Chief Executive Officer of Visby Medical, is driven to bring the confidence and comfort that accurate testing of infectious diseases provides to patients, caregivers and the population at large.
“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 de la Zerda. “Our innovative technology has been tested, reviewed and endorsed by leading academics and health care researchers.”
Visby Medical will continue to work to expand authorized use cases to help provide a sense of security to critical areas of our healthcare system, military, consumer businesses and schools, providing a means for these institutions to reopen and allow people to return to work safely.
About Visby Medical™:
Visby Medical has been working to change the order of diagnosis and treatment of infectious disease for a decade. Visby Medical has a single-use Personal PCR diagnostic to rapidly test for serious infection. Tested, reviewed, and endorsed by top public and private organizations, the first commercial application of the Visby Medical technology received FDA emergency use authorization for moderate-complexity laboratory testing of symptomatic patients in the fight against COVID-19. Visby is ramping production of its COVID-19 diagnostic test and is gaining government and private partnerships to accelerate the delivery of Personal PCR, designed for use at the point of care, and eventually for use at home.
Contact: Stefanie Tuck, (978)390-1394, email@example.com