Diagnostic maker Cellex has announced plans to develop a rapid coronavirus infection test that people can fully perform at home, from sample collection to result—with 15-minute readings double-checked by a personal smartphone app.
The company is partnering up with Gauss, a developer of machine vision-based healthcare programs, to help digitize the results of its upcoming COVID-19 antigen test.
Cellex said it is currently working to validate its diagnostic, which has previously shown a false negative rate of about 10% while returning no false positive results, through clinical trials.
Meanwhile, the smartphone app from Gauss aims to provide step-by-step video instructions on how to self-collect a nasal swab sample and perform the test. After 15 minutes, the app prompts the user to scan the result using the smartphone’s camera, which reads the image and confirms whether it is positive or negative.
“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,” said James Li, founder and CEO of Cellex, which previously received the FDA’s first emergency authorization for a rapid COVID-19 antibody blood test in April.
The app will also help automatically report results to public health authorities to aid in contact tracing while giving users who have tested negative a mobile pass showing the result. Outside of the home, when used by healthcare professionals, the app can send results to a patient’s electronic health record.
“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,” Gauss founder and CEO Siddarth Satish said.
Cellex and Gauss said they aim to have the antigen test and companion app authorized by the FDA this fall.