LumiraDx Receives Approval for its COVID-19 Antigen Test for use 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
• LumiraDx’s microfluidic technology and innovative Point of Care (POC) Platform supports a broad menu of tests with lab-comparable performance, at a low cost, with results available in minutes

Today, LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics testing company announced 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. 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% 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 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.

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.

The company currently has five tests on the market including its comprehensive portfolio of fast, accurate, and cost-efficient 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.

“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. “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.”

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

The LumiraDx platform is being used globally including by the National Health Service (NHS) and Boots in the UK, CVS Pharmacy in the US, a significant number of accident and emergency rooms in Italy and other parts of Europe, hospital systems in Japan and across South America, and is being deployed in partnership with the Bill & Melinda Gates Foundation in a growing number of African countries where access to high-quality diagnostics is limited.

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