LumiraDx receives CDSCO approval for COVID-19 antigen test use in India
LumiraDx’s microfluidic technology and innovative POC Platform supports a broad menu of tests with lab-comparable performance, at a low cost, with results available in minutes
LumiraDx, a next-generation point of care diagnostics testing company, has received emergency use approval by India’s Central Drugs Standard Control Organisation (CDSCO) for its SARS-CoV-2 Antigen test for use in India. The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.
In clinical studies, LumiraDx SARS-CoV-2 Antigen test demonstrated a 97.6 per cent positive agreement and 96.6 per cent negative agreement with the PCR test for patients within the first 12 days of symptom, making it one of the fastest, and most sensitive antigen point of care tests currently commercially available. The test has been available in the US and Europe after receiving Emergency Use Authorization (EUA) granted by the US Food and Drug Administration (FDA) in August 2020 and has obtained CE Mark in September 2020 respectively.
The LumiraDx SARS-CoV-2 Antigen test is a microfluidic test run on the LumiraDx point of care Platform which scales down and integrates techniques used in laboratory analyzers to provide lab-comparable diagnostic tests on a single point of care instrument. The Platform consists of a small, portable instrument; microfluidic test strip; simple, standardised workflow; and seamless, secure digital connectivity to the cloud and hospital IT systems.
“The mission of LumiraDx is to transform community-based healthcare through POC diagnostics and make lab-comparable tests accessible to all,” stated David Walton, LumiraDx Chief Commercial Officer.
Yogesh Singh, GM India, LumiraDx explained, “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.”
