Gauss announces results of clinical study intended to support FDA EUA for first at-home rapid antigen test for COVID-19

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Study demonstrated test performance of 94% positive percent agreement, 97% negative percent agreement when using computer vision app

Gauss, a leading developer of computer vision applications for healthcare, today announced results from its clinical study for an at-home rapid antigen test for COVID-19. If authorized by the Food and Drug Administration (FDA) under Emergency Use Authorization (EUA), the test could be among the first allowing people to test themselves at home for active COVID-19 infection and receive results at home within minutes.

The study consecutively enrolled both symptomatic and asymptomatic participants spanning a variety of ages, education and socioeconomic backgrounds. The primary goal of the study was to assess the performance of the at-home rapid test and smartphone app compared to an EUA-authorized Polymerase Chain Reaction (PCR) test for SARS-CoV-2 infection performed in a high-complexity CLIA-certified laboratory.

To perform the at-home rapid test, users followed step-by-step video instructions in the app to self-collect a nasal swab sample, briefly soak it in a buffer solution, and dispense the solution onto the antigen test cassette. After 15 minutes, the app prompted the user to scan their rapid test with their smartphone and the scanned image was analyzed with Gauss’ computer vision and neural network algorithm to generate a final test result. Nasopharyngeal (NP) swab samples for PCR analysis were collected by clinicians in the same setting.

The Gauss algorithm-generated test results were compared with the time-matched, PCR tests to establish performance. Participants who tested positive by PCR included a wide range of viral loads, with PCR threshold cycle (Ct) values spanning from strongly PCR positive to weakly PCR positive. A total of 159 participants were enrolled, which included 36 participants who were COVID-19 positive by PCR and 123 participants who were negative by PCR. The at-home rapid test results demonstrated 94% positive percent agreement and 97% negative percent agreement compared to the PCR gold standard.

Gauss has recently submitted a Pre-EUA package to the FDA and will be following with a full EUA submission including these clinical study results. The Gauss antigen test includes a test cassette manufactured by Cellex, a biotechnology company specializing in point-of-care diagnostics. The companies recently announced an exclusive partnership on the rapid at-home test and computer vision-enabled smartphone app.

Learn more about the Gauss-Cellex at-home rapid antigen test at covid19.gauss.com.

Note that an Emergency Use Authorization is not an FDA approval or clearance of a product but allows commercialization of the product for the duration of the declared public health emergency.

About Gauss
Gauss is a 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, with 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.

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