BARDA is partnering with LightDeck Diagnostics to develop an ultra-rapid, high-performance, point-of-care antigen test to screen patients and rapidly diagnose SARS-CoV-2 infections. This latest agreement between BARDA and LightDeck provides additional studies required for U.S. Food and Drug Administration (FDA) to consider Emergency Use Authorization (EUA) in non-clinical settings, and for the company to request full 510(k) clearance to market the SARS-CoV-2 antigen test kits.
The LightDeck COVID-19 Antigen Test is designed to diagnose infections with the SARS-CoV-2 virus in six minutes or less, delivering laboratory-quality results without requiring a full diagnostic laboratory. This can provide critical data to aid in COVID-19 infection assessment and aid healthcare providers and patients in making decisions about treatment, contact tracing, and public health protection measures.
If development is successful, the LightDeck antigen test could be used for on-site screening of people in non-clinical settings, such as nursing homes, essential workplaces, and other community testing sites, thereby helping to increase and expand the throughput of COVID-19 testing.
About LightDeck Diagnostics:
The following information is provided by company and does not indicate endorsement by the federal government of the company or its products.
LightDeck Diagnostics believes in a new approach to healthcare, where quick and accurate diagnostic tests will be run wherever and whenever they are needed, without compromise. The company’s proprietary LightDeck platform combines an advanced laser waveguide with novel materials and patented manufacturing techniques to deliver lab-quality results anywhere, in minutes. LightDeck is introducing a portfolio of in vitro diagnostic panels, the first is an on-the-spot test for COVID-19, followed by highly accurate host-response panels to manage acute infections and sepsis, and next-generation tests for heart attack triage. The LightDeck platform is also marketed successfully in veterinary diagnostics and environmental testing. Learn more at www.LightDeckDx.com.