Headquartered in Somerset, Premier Medical Corp. said April 7 it plans to submit its Sure Status COVID-19 Antigen Card Test to U.S. Food and Drug Administration (FDA) for inclusion in the Emergency Use Authorization program for distribution and use in the U.S. this month.
This comes after the test was included by the World Health Organization (WHO) in its Emergency Use Listing worldwide.
The test was entirely developed and manufactured at PMC’s facility in India. Distribution in the U.S., will originate from its location in Somerset by Premier Medical USA Corp.
The test is performed by taking a sample from your 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%. This makes it possible to quickly and conveniently test people in a variety of settings, including schools, workplaces and doctor’s offices without the need for additional equipment.
The company is also currently 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.
PMC is a worldwide leader in developing cost-effective point-of-care rapid tests. The company currently employs seven people at its New Jersey research and development facility, along with more than 500 people at its manufacturing facility in the State of Gujarat, India.