- Major clinical study of over 550 samples conducted in Italy delivered 92.7% Sensitivity and 96.8% Specificity
- Latest generation antigen test assay utilising non-invasive mouth swab samples together with the SpectraLIT® spectrometer and AI to detect the absence or presence of COVID-19
- Updated CE certification obtained for Virusight solution with further certifications underway
Ness Ziona, Israel,25 May, 2022: Virusight Diagnostic, a world leader in combining artificial intelligence software and spectral technology today announced the results of a major clinical study that found its ultra-rapid, point of care Pathogens Diagnostic solution consistently delivers 96.3% accuracy when compared to the gold standard RT-PCR. The study was conducted by the Department of Science and Technology, University of Sannio, Benevento, Italy and conducted in conjunction with Virusight’s partner TechnoGenetics S.p.A.
The study was conducted on 550 salivary samples from male and female subjects without age limits. The Virusight solution demonstrated an overall sensitivity of 92.7% (positive percent agreement) and specificity of 96.8% (negative percent agreement) as compared to an EC marked RT-PCR and was shown to be a safe and reliable test for the detection of SARS-CoV-2 antigens and/or virus particles in oral swab samples, providing diagnosis of active COVID-19, including mutations, in 20 seconds.
Innovative technology provides highly accurate, non-invasive COVID-19 testing
The Virusight test consists of a unique combination of innovative technologies to deliver accurate results that unlike lateral flow devices are consistent and not subject to variation. Samples are collected via a mouth swab and immediately immersed into a cuvette containing a reagent.
The company’s SpectraLIT® device – a miniaturised highly sensitive spectral photometer – is used to obtain a spectral signature of the sample. This is analysed using Artificial Intelligence based on machine learning models that have been trained to identify and differentiate the presence &/or absence of SARS-CoV-2. Using Virusight proprietary software, the result is then transmitted via a secure cloud connection to a mobile computer or phone within 20 seconds.
Virusight is a joint venture between the ARC Center for Digital Innovation at Sheba Medical Center and Newsight Imaging, developer of advanced CMOS image sensor chips. Through Newsight, the Virusight solutionis registered as an approved IVD device and has obtained the CE Mark for the European market for its latest product. It also has a regulatory pipeline of approvals in process together with significant interest from potential partners across numerous markets including the UK, US, LATAM and Asia Pacific. The solution will be available for commercial use in the European market in the coming weeks.
Delivering the future of Point of Care Pathogens Diagnostic
Professor Eyal Zimmlichman, Chief Innovation Officer at Sheba Medical Center and the Director and Founder of ARC said, “The findings of this Clinical Report herald the introduction of the next generation of pathogens diagnostic and point of care testing. The real value of this way of testing will be seen at the point of care. Having this technology available in pharmacies, doctor’s surgeries, aged care facilities and clinics will enable definitive diagnosis immediately, resulting in faster treatment and better health outcomes for patients worldwide.”
“Virusight’s SpectraLIT® solution provides consistently reliable ultra-rapid testing that correlates with RT-PCR for a fraction of the cost and time” commented Virusight CEO, Gary Cohen. “This will be a game changer for industry that is still dealing with the ongoing effects of COVID-19 through lost productivity. Organizations around the globe are trying to rebuild their businesses while still experiencing an average of 33% absenteeism, which is costing many millions of dollars a day. Having a simple, reliable non-invasive test available at the workplace will significantly help reduce transmission and keep employees and customers safe and healthy.”
“The Virusight solution is scalable and easily implemented in any environment. The solution will help the education, travel and entertainment industries operate safely and without costly disruptions. The company is also currently looking at other pathogens that can be detected by the SpectraLIT®, such as HPV. The ability to do a rapid detection of these conditions will save lives for millions of patients.” Cohen explained.