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LumiraDx Gets Emergency Use Approval In India For COVID-19 Antigen Test; Stock Surges

LumiraDx (LMDX) said that it has received emergency use approval by India's Central Drugs Standard Control Organisation for its SARS-CoV-2 Antigen test for use in India.

In Wednesday pre-market trade, LMDX was trading at $13.50 up $5.07 or 60.14%.

The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application.

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.

In clinical studies, 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, making it one of the fastest, and most sensitive antigen point of care tests currently commercially available.

The company noted that it currently has five tests on the market including its 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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