“The continued support from NIH through the highly competitive RADx initiative is a testament to Visby Medical’s credibility and commitment to stopping the spread of serious infections such as COVID-19,” says Adam de la Zerda, Founder and CEO of Visby Medical. “This funding is instrumental in implementing high-volume production lines to accelerate our manufacturing capabilities and meet the demand. We are humbled by this generous support of the NIH that will help scale our production of Personal PCRs.”
“Visby Medical has the potential to completely change infectious disease diagnostics by creating a fundamentally new and different testing paradigm,” says Dr. Gary Schoolnik, Chief Medical Officer at Visby Medical and Professor of Medicine at Stanford University specializing in infectious diseases. “Visby has shortened the testing process and introduced a rapid PCR diagnostic for COVID-19.”
Visby Medical’s single-use, palm-sized Personal PCR platform is expected to provide a sample-to-result in less than 30 minutes. On September 16, 2020, Visby Medical received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Personal PCR device for use in moderate complexity CLIA certified laboratory settings. While currently only authorized for use in moderate complexity labs, the device is designed to one day benefit both point-of-care (POC) and over-the-counter (OTC) use cases, thus avoiding lengthy delays caused by sample transport, lab analysis, and result reporting. The device is designed to enable rapid, geographically distributed testing with accuracy equal to lab PCR instruments, meeting a critical, and as yet missing, need for testing in the U.S.
Through the RADx initiative, NIH is not only supporting the response to this pandemic, but is laying the diagnostic foundation for the next one. The funding is improving aspects of the current testing paradigm – sample collection and transport, lab processing, point-of-care tests, etc. – while accelerating the commercial viability of potentially paradigm changing tests, such as Visby Medical’s Personal PCR. Visby Medical was founded to one day bring Personal PCR out of the lab and into homes, field hospitals, or even convenience stores. Such a development would fundamentally shift the practice of disease diagnosis, better preparing society to handle future pandemics.
This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health. The current contract is funded from the Public Health and Social Services Emergency Fund through the Biomedical Advanced Research and Development Authority, HHS Office of the Assistant Secretary for Preparedness and Response, Department of Health and Human Services.
Visby Medical plans to use the funds to help secure its supplier base and implement automation to scale up manufacturing.
About Visby Medical:
Visby Medical has developed single-use, Personal PCR 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 will be in the fight against COVID-19. Visby is ready to ramp production and is gaining government and private partnerships to accelerate the delivery of Personal PCR. Going-to-market with a new diagnostic is a collaborative process, and Visby is working with key private and public leaders to help ensure society is best served by COVID-19 test results.
For more information, visit www.visbymedical.com. Follow Visby Medical on LinkedIn at www.linkedin.com/company/visbymedical; Facebook, Instagram, and Twitter @VisbyMedical.
About RADx: RADx Tech and RADx Advanced Technology Program leverage the Point-of-Care Technology Research Network (POCTRN) administered by NIBIB and spanning multiple leading universities, in order to manage, evaluate, and validate technologies. In addition, RADx partnerships with federal agencies, including the Office of the Assistant Secretary of Health, Department of Defense, the Biomedical Advanced Research and Development Authority, and FDA play a critical role in program operations and, in some cases, joint project support.
About the National Institute of Biomedical Imaging and Bioengineering (NIBIB): NIBIB’s mission is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care. NIBIB supports emerging technology research and development within its internal laboratories and through grants, collaborations, and training. More information is available at the NIBIB website: https://www.nibib.nih.gov
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
SOURCE Visby Medical