NEW YORK — Cellex has partnered with medical software firm Gauss to launch a SARS-CoV-2 antigen test for at-home and point-of-care use, the companies said on Wednesday.
Cellex is developing a test to detect the SARS-CoV-2 nucleocapsid protein in nasal swab samples. According to the firm, the test has shown almost 90 percent sensitivity and 100 percent specificity in early clinical testing. The companies said they will integrate this test with a mobile phone application developed by Menlo Park, California-based Gauss that provides instructions on how to collect a nasal swab specimen and perform the test, then analyzes the sample to provide results within 15 minutes.
The app can also facilitate the automatic reporting of test results to health authorities, as well as electronic health record and laboratory information systems, the companies added.
The test is expected to be submitted to the US Food and Drug Administration for Emergency Use Authorization later this year.
"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," Gauss Founder and CEO Siddarth Satish said in a statement. "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."
In April, Research Triangle Park, North Carolina-based Cellex became the first company to receive EUA from the FDA for a SARS-CoV-2 serology test.