MENLO PARK, Calif. (PRWEB) September 16, 2020
Gauss, the leading developer of computer vision applications for healthcare, and Cellex, a leading biotechnology company specializing in point-of-care diagnostic testing, today announced an exclusive partnership to launch the first-ever rapid, at-home and point-of-care COVID-19 antigen test. If authorized by the Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) this fall, the test would be the first allowing people to test themselves for active COVID-19 infection and receive rapid results within the confines of their own home or similar user environments.
Cellex, which was the first company to receive an FDA Emergency Use Authorization for rapid COVID-19 antibody testing on April 1, 2020, is now in advanced clinical trials with a rapid antigen test that targets the nucleocapsid (N) protein on the SARS-CoV-2 virus and has demonstrated nearly 90% sensitivity and 100% specificity in early trials. When paired with a newly developed, AI-powered application from Gauss that enables non-expert users to perform and interpret the test with an iPhone or Android phone, its use can be expanded to aid in the rapid diagnosis of SARS-CoV-2 infections in both at-home and point-of-care settings.
To perform at-home testing, users follow step-by-step video instructions in the app to correctly collect a nasal swab sample and perform the rapid antigen test. Within 15 minutes, the app prompts the user to scan their rapid test with their smartphone and then processes the image with an end-to-end neural network architecture optimized for the Cellex assay. The app informs the user if the test result is negative or positive for SARS-CoV-2 antigens within seconds. Gauss’s patent-pending, AI-driven assay reading technology overcomes the limit of detection of the untrained human eye and can also minimize inter-reader variability routinely seen in interpreting antigen test results. Put together, the solution will deliver fast and reliable results on an encrypted, HIPAA-compliant, consumer-friendly app.
The Gauss-Cellex announcement comes amidst a growing consensus among public health officials and business leaders that a widely-accessible rapid antigen testing solution is needed to decrease the public health threat from COVID-19 and mitigate the pandemic’s economic impact until a vaccine is widely available. A rapid, reliable, inexpensive and consumer-friendly at-home antigen test would significantly reduce virus transmission, particularly by asymptomatic and pre-symptomatic patients, while enabling people with negative results to engage in their day-to-day activities – from going to work, going to school, shopping, visiting a relative or vacationing – with a significantly lower risk of transmission. However, widespread use of rapid tests is currently limited by the need for trained clinical operators or specialized laboratory equipment to ensure that tests are performed and interpreted accurately.
“The integration of Cellex’s accurate, at-home rapid antigen test with Gauss’s mobile app offers a scalable solution to significantly reduce transmission of COVID-19 and help society mitigate the impacts of the pandemic until a vaccine is widely available,” Gauss Founder and CEO Siddarth Satish said. “By embedding advanced computer vision algorithms within a thoughtfully-designed user experience, we can enable consumers to perform a rapid test in their own homes just as well as a trained operator or a laboratory instrument - simply by using their smartphone cameras.”
“The partnership between Gauss and Cellex is highly synergistic and natural,” Cellex Founder and CEO James Li, PhD said. “While Gauss has deep expertise in applied computer vision and FDA-cleared mobile apps, Cellex has been pioneering technologies for point of care diagnosis, including rapid testing for SARS-CoV-2. This AI-enabled COVID-19 antigen test for home use will make self-monitoring and isolation feasible, thereby playing a significant role in changing the trajectory of the COVID-19 pandemic in America and beyond.”
In addition to reading tests and displaying results, the Gauss app can facilitate automatic reporting of data to health authorities and give users a mobile pass temporarily storing their status. For point-of-care and laboratory users, the app can enable clinical users to automatically send data to electronic medical record (EMR) and laboratory information systems as well. The Gauss app is available on the Apple App Store and is already being used by research teams at two prominent universities to power large-scale, at-home research studies on COVID-19.
Learn more about the Gauss-Cellex rapid antigen test at http://covid19.gauss.com.
About Gauss: Gauss is the leader in computer vision in healthcare. Founded in 2011, Gauss’s mission is to digitally augment clinicians with software that radically improves diagnostic accuracy and leads to improved patient safety and clinical outcomes. Gauss’s flagship product, Triton, leverages computer vision to detect surgical and obstetric hemorrhage in real time and notifies clinicians who can enact timely intervention and treatment. Triton was granted De Novo clearance from the U.S. Food and Drug Administration (FDA) in 2014, as the first-ever computer vision software for surgical use, and several follow-on 510(k) clearances. Available on the iPhone, Triton has been widely adopted by health systems in the United States and is a recipient of the Apple Design Award, which recognizes the best in design, innovation and technology on Apple platforms. For more information, visit http://www.gauss.com.
About Cellex: Founded in 2002, Cellex is a pioneer accelerating the era of decentralized medicine. Cellex’s suite of diagnostics products for combating infectious diseases is based upon innovative point-of-care (POC) platform technologies. On April 1, 2020, Cellex was the first company to receive an FDA Emergency Use Authorization for a COVID-19 antibody test. Its rapid tests have been in widespread use by several states in the U.S.A and across the globe through the COVID-19 pandemic. To learn more, visit http://www.cellex.us.