Home 5 Articles 5 LumiraDx Gets CE Clearance for Five Different Products

LumiraDx Gets CE Clearance for Five Different Products

by | Jun 17, 2022 | Articles, News, Open Content

The UK-based diagnostics firm received CE marks for a diabetes test, CHF test, as well as an analyzer, and two COVID-19 tests.

UK-based diagnostics company LumiraDx has had a good several weeks so far in terms of receiving CE marks, gaining the designation for five different products in recent days. Here’s a quick summary:

May 26: Received CE designation for its diabetes blood test that measures hemoglobin (Hb) A1c levels. The point-of-care test, which aims to screen and identify those who may develop diabetes as well as monitor those who have diabetes, provides results in less than seven minutes.

June 2: Gained CE marking for its new NT-proBNP [N-terminal (NT)-pro hormone BNP] test for congestive heart failure (CHF). The rapid microfluidic immunofluorescence assay offers quantitative measurement of NT-proBNP in human plasma, venous whole blood, and human capillary specimens to help diagnose CHF.

June 8: Gains CE marking for two high-throughput molecular tests, one that tests for both the influenza and SARS-CoV-2 viruses as well as one that just detects SARS-CoV-2. The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay can simultaneously detect and differentiate between the influenza A and B viruses, as well as SARS-CoV-2. On the other hand, the Dual-Target SARS-CoV-2 STAR Complete molecular test identifies the presence of the COVID-19-causing virus through the detection of two gene markers. Both tests run on open RT-PCR instruments and provide results within 20 minutes.

June 9: Received CE marking for its portable COVID-19 testing instrument, the Amira Analyzer. The instrument reads Amira SARS-CoV-2 Ag test strips to detect SARS-CoV-2 antigens in about 15 minutes. Currently, the CE designation covers the use of the instrument by healthcare professionals at the point of care but the company says it plans to expand its use to the home and by non-professionals.

LumiraDx saw strong performance in the first quarter of 2022, with a Q1 revenue of $126.4 million compared to $106.9 million for the first quarter of 2021.