LumiraDx Limited (NASDAQ:LMDX), a next-generation point of care diagnostics company, today announced that it has achieved CE Mark for the Amira System, its new testing system that provides low-cost, highly sensitive COVID-19 testing. The Amira Analyzer reads the included Amira SARS-CoV-2 Ag test strips and returns a result in just 15 minutes. The Amira Analyzer condenses technology from large laboratory analyzers into a portable instrument, comparable in size and weight to a deck of playing cards, that delivers high performing testing in minutes. The initial CE Mark for the Amira System covers professional use at the point of care. However, the company plans to seek additional regulatory approvals and authorizations for the Amira System, including those required for non-professional, over the counter use, to provide value for home, events, workplace, and travel testing.
The microfluidic technology in the Amira SARS-CoV-2 Ag test delivers excellent testing performance. The test has a positive percent agreement of 90.00% and a negative percent agreement of 99.31% versus RT-PCR in symptomatic individuals, based on clinical data collected 0-10 days since symptom onset. Within this cohort, the Amira SARS-CoV-2 Ag test showed sensitivity of 95.6% up to a CT of 30 indicating high coverage of potentially infectious individuals.
Ron Zwanziger, LumiraDx's Chief Executive Officer commented, "The Amira System brings a unique combination of features to the market. It is one of the only COVID-19 testing solutions on the market that can offer highly accurate, objectively read results with the rapid turnaround time and low price of many lateral flow tests. Frequent testing has become a part of many of our lives in order to limit the spread of the virus. However, without trusted results, many testing protocols do not accurately protect patients, employees, and families."
The Amira System will be commercially available in Europe shortly as a starter kit with one analyzer and 200 Amira SARS CoV-2 Ag test strips.