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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Chevron Corporation (CVX) reported fourth quarter profit of $5.1 billion or $2.63 per share, compared to a loss of $665 million or $0.33 per share, previous year. The company's U.S. upstream operations earned $2.97 billion, compared to $101 million, a year ago. The company said the improvement was primarily... While reporting financial results for the fourth quarter on Friday, Colgate-Palmolive Co. (CL) initiated its earnings and sales growth guidance for the full-year 2022. For fiscal 2022, the company now expects earnings per share to grow in double-digit percentage and adjusted earnings per share growth... Caterpillar Inc. (CAT), a manufacturer of mining and construction equipment, reported Friday that fourth-quarter net income more than doubled to $2.12 billion or $3.91 per share from $780 million or $1.42 per share in the prior-year quarter. Excluding special items, adjusted net income for the quarter...
Follow RTT