Once authorized, the Gauss test will be available for purchase on Kroger.com. It will be the first rapid COVID-19 test that can be entirely performed using only a smartphone and a lateral flow assay, which is similar to an at-home pregnancy test. The test won’t require a lab, a telemedicine visit or any specialized electronics. Gauss in January produced its first 1.5 million tests, which it said would be available for immediate distribution once the FDA grants the emergency use authorization, and the company has the capability to product as many as 30 million tests per month.
"Since the start of the COVID-19 pandemic, Kroger Heath has remained committed to helping people live healthier lives by offering a variety of COVID-19 testing solutions supported by our multi-disciplinary team of licensed, trained and experienced healthcare providers," said Colleen Lindholz, president of Kroger Health. "We're proud to partner with Gauss to expand our COVIDCare+ suite with the forthcoming launch of this affordable, innovative solution."
To use the test, patients follow step-by-step video instructions in an app to properly collect the nasal swab and compete the rapid antigen test. After 15 minutes, the app prompts the patient to scan the rapid test, then uses artificial intelligence-based technology to provide patients with their results, helping minimize reader variability. The app also seamlessly shares secure, HIPAA-compliant results with appropriate public health agencies to fulfill legal reporting requirements.
"Public health leaders agree that people need access to on-demand, reliable, rapid testing in their own homes, and that's exactly what our test delivers," said Siddarth Satish, Gauss founder and CEO. "As a trusted resource for COVID-19 related solutions with a broad national footprint, Kroger Health is an ideal partner to dramatically expand access for millions of Americans through our smartphone-powered, at-home COVID-19 rapid antigen test."
Gauss developed the test with Cellex, a biotech company specializing in rapid diagnostics, and the app powering the test is encrypted and HIPAA compliant.