LumiraDx (NASDAQ: LMDX) has received emergency user approval for the SARS-CoV-2 Antigen test in India from the Central Drugs Standard Organisation. The diagnostic Antigen test is designed to detect antigen nucleocapsid protein from nasal swab, and results are available within 12 minutes of the sample application.
LumiraDx SARS-CoV-2 antigen test comparable to PCR test
The company’s SARS-CoV-2 antigen test shows 97.6% positive agreement and 96.6% negative agreement relative to the PCR test in clinical trials for patients within 12 days after symptoms start appearing. This makes it one of the most sensitive and quickest antigen point-of-care tests available. Following the EUA award from the US FDA in August 2020 and a CE Mark in September 2020, the test is now available in Europe and the US.
The SARS-CoV-2 Antigen test is a microfluidic test performed on the LumiraDx point-of-care Platform, which integrates lab analyzer techniques to give lab-comparable diagnostic tests on single point-of-care equipment. A tiny, portable instrument, a simple, standardized process, a microfluidic test strip, and seamless, secure digital communication to the cloud and hospital IT systems are all part of the Platform.
LumiraDx POC test accessible to all
LumiraDx Chief Commercial Officer David Walton said:
The mission of LumiraDx is to transform community-based healthcare through POC diagnostics and make lab-comparable tests accessible to all. Our launch in India with our SARS-CoV-2 Antigen test is an important step forward in this mission. We are proud to now have a presence in one of the world’s fastest-growing economies and have the opportunity to partner with local health systems and businesses across the country to provide highly accurate and rapid testing.
The company’s General Manager India, Yogesh Singh, said:
There is a significant need for high-quality, accurate point of care testing across India to meet not only the current demand with COVID-19, but also to provide testing for a number of health conditions beyond the pandemic. Launching the LumiraDx Platform and microfluidic technology, first with the SARS-CoV-2 Antigen test, will provide next generation POC testing for patients in rural, urban and semi-urban health settings in India enabling healthcare providers to reduce the impact of acute and chronic diseases across the country.
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