Premier Medical Corporation's COVID-19 Antigen Test to Seek Emergency Use Authorization in the U.S.

SOMERSET, N.J., April 7, 2021 /PRNewswire/ -- Premier Medical Corporation (PMC) – a leading manufacturer of COVID-19 Antigen and Antibody tests – plans to submit its COVID-19 Antigen rapid test for U.S. approval this month.

PMC is submitting the Sure Status COVID-19 Antigen Card Test to the Food and Drug Administration (FDA) for inclusion in the Emergency Use Authorization program for distribution and use in the U.S.

This comes after the test was included by the World Health Organization (WHO) in its Emergency Use Listing worldwide.

Premier Medical Corporation is just the third company in the world, and the only Indian-based company, to accomplish this feat.

The simple and affordable 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 test was entirely developed and manufactured in India. For distribution in the U.S., it will be distributed from Somerset, New Jersey by Premier Medical USA Corporation.

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.

Premier Medical Corporation is a global leader in developing, manufacturing and distributing diagnostic testing for infectious diseases, including for HIV, Malaria, Hepatitis and Syphilis. It has collaborated with leading universities and the Centers for Disease Control to develop novel tests for various infectious diseases.

Headquartered in Somerset, New Jersey, Premier Medical USA Corporation 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. 

For additional information, please contact: [email protected].

For press inquiries, please contact Natasha Alagarasan at [email protected].

SOURCE Premier Medical Corporation