Gauss, Cellex Launch First At-Home COVID-19 Antigen Test

Gauss and Cellex recently announced an exclusive partnership to launch the first-ever rapid, at-home COVID-19 antigen test.

Once approved by FDA, the test would be the first to allow individuals to test themselves for active COVID-19 infection and receive rapid results while at home. 

“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 in the announcement. 

“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.”

Cellex previously received FDA emergency use authorization for its rapid COVID-19 antibody test back in April. The company is now in advanced clinical trials with a rapid antigen test that targets the nucleocapsid protein on the SARS-CoV-2 virus, the press release stated.

In early trials, the antigen test has shown 90 percent sensitivity and 100 percent specificity.

When paired with Gauss’ artificial intelligence-powered application, which allows anyone to perform and interpret the test with a phone, the test can be expanded to assist in the rapid diagnosis of SARS-CoV-2 infections in both at-home and point-of-care settings, the companies said. 

AI technology minimizes inter-reader variability, which is caused by measurement differences from multiple users. Inter-reader variability is generally seen in the interpretation of antigen test results. 

Put together, the solution will deliver fast and reliable results on an encrypted, HIPAA-compliant, user-friendly app, the companies stated.

To correctly collect test samples, users will receive step-by-step instructions to perform the rapid test. Individuals can scan their rapid test with their smartphone within 15 minutes after testing.

Gauss’ AI app then informs the user if the test result is negative or positive for SARS-CoV-2 antigens within seconds. 

Additionally, the app can generate automatic reporting of data to health authorities and give users a mobile pass that will temporarily store their status. Clinical users are able to send data to electronic medical record and laboratory information systems as well. 

“The partnership between Gauss and Cellex is highly synergistic and natural,” said James Li, PhD, Cellex Founder and CEO.

“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.”

The Gauss-Cellex announcement comes as public health officials and healthcare stakeholders raise concerns about a widely accessible rapid antigen testing solution, which many believe is needed to decrease the public health threat from COVID-19.

An efficient at-home antigen test would significantly reduce virus transmission, specifically by asymptomatic and pre-symptomatic patients. It would also allow individuals who receive negative tests to continue with their everyday activities, including work and school, supports say. 

Many pharmaceutical and biomedical technology companies have been working on developing an effective at-home testing tool. 

At the beginning of the pandemic, for example, Alveo Technologies and Janssen Pharmaceuticals advanced an at-home testing platform that detects viral infections, such as COVID-19.

The be. well testing system includes analyzers, nasal swabs, and cartridges for the detection of viral infection diseases, including Respiratory Syncytial Virus (RSV) and SARS-CoV-2. The platform can be adapted to detect a wide range of diseases that threaten public health.

“Affordable access to real-time, at-home results will transform the way individuals, healthcare providers and public health professionals identify and manage disease outbreaks,” the company stated.

But the FDA has yet to approve an at-home COVID-19 test, leaving the market open for companies to innovate.