LumiraDx gets approval for its COVID-19 Antigen Test in India

Test combines sensitivity with speed and is designed to be used in health care settings to aid with rapid diagnosis of COVID-19

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LumiraDxDiagnostics testing company LumiraDx has received emergency use approval by India’s Central Drugs Standard Control Organisation 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.

LumiraDx SARS-CoV-2 Antigen test demonstrated a 97.6% positive agreement and 96.6% negative agreement with the PCR test for patients within the first twelve days of symptom in clinical studies. With this, it stands as 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 U.S. Food and Drug Administration (FDA) in August 2020 and having obtained CE Mark in September 2020 respectively.

LumiraDx SARS-CoV-2 Antigen test

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, standardized workflow; and seamless, secure digital connectivity to the cloud and hospital IT systems.

David Walton, LumiraDx Chief Commercial Officer, said, “Our launch in India with our SARS-CoV-2 Antigen test is an important step. 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.”

Yogesh Singh, LumiraDx General Manger, India stated, “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.”

The company currently has five tests on the market including its comprehensive portfolio of COVID-19 testing solutions, as well as its INR and D-Dimer tests which are both commercially available in Europe. It is currently developing tests for Covid/Flu, CRP, HbA1c, high sensitivity troponin I, and Tuberculosis (TB) – all with the aim of consolidating multiple POC platforms onto a single next-generation POC platform.

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