Research & Development
Premier Medical Corporation's COVID-19 antigen test filed for FDA's EUA for distribution across the US
8 April 2021 -

Indian diagnostic company Premier Medical Corporation (PMC) revealed on Wednesday that it intends to file its COVID-19 Antigen rapid test with the US Food and Drug Administration (FDA) to quickly and conveniently test people in schools, workplaces and doctor's offices.

The company will submit the Sure Status COVID-19 Antigen Card Test to the US FDA for inclusion in the Emergency Use Authorization programme for distribution in the US upon inclusion in the World Health Organization's (WHO) Emergency Use Listing worldwide.

According to the company, the simple and affordable Sure Status COVID-19 Antigen Card test is based on the sample from the nose to determine if it contains viral genetic material, giving results in just about 15 minutes. The specificity is 100% and the sensitivity is 94.5%.

In addition, Premier is the third company in the world and the only Indian-based company to accomplish this feat. The test was entirely developed and manufactured in India. It will be distributed from Somerset, New Jersey by Premier Medical USA Corporation.

Currently, the company is in the process of developing a test for the detection of other variants of COVID-19 based on its patented platform technology and rapid saliva testing, which would be a key part of bringing the virus and its transmission under control.



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