LumiraDx Five-Minute SARS-CoV-2 Ag Ultra Test Earns CE Mark

  • Results are obtained in just 5 minutes from sample application, aiding rapid clinical decision making at the point of care (POC), helping to inform treatment decisions and prevent the spread of infection, while which increases test performance
  • The innovative strip design of the Ultra Test, running on the LumiraDx multi-assay platform, is based on the company’s microfluidic immunofluorescence technology and enables faster reaction times without sacrificing sensitivity.
  • Available on the same POC platform as LumiraDx’s highly sensitive SARS-CoV-2 Antigen, Flu A/B, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool, as well as INR, D-Dimer, and CRP* ​​tests

LONDON, May 19, 2022 /PRNewswire/ — LumiraDx Limited (Nasdaq: LMDX), a next-generation point-of-care diagnostics company, today announced that its SARS-CoV-2 Ag Ultra Test has achieved the CE mark. The Ultra test provides digital and connected results in just five minutes with high sensitivity, making it one of the fastest and most sensitive COVID-19 antigen tests available. The time reduction allows clinicians to treat patients much faster, and increases the throughput of the LumiraDx platform, now allowing users to complete up to 80 SARS-CoV-2 antigen tests per eight-hour day, or up to 10 per hour, on a single LumiraDx instrument.

The advances made with the Ultra test strip design reflect the company’s continued innovation in its microfluidic immunofluorescence technology, which allows higher sample volumes to enter the test strip chambers to increase detection levels, achieve faster reaction times and even greater accuracy. This new technology runs on the existing LumiraDx platform and can be applied to future platform tests.


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The LumiraDx SARS-CoV-2 Ag Ultra test has the same high performance as the LumiraDx SARS-CoV-2 Ag 12 min test. The test has a positive percent agreement of 92.7% and a negative percent agreement of 100% versus RT-PCR in symptomatic individuals, based on clinical data collected 0 to 12 days from symptom onset. Within this cohort, the LumiraDx SARS-CoV-2 Ag Ultra test showed a high sensitivity of 97.4% up to a CT of 35, indicating high coverage of potentially infectious individuals.

In addition, the LumiraDx SARS-CoV-2 Ag Ultra test demonstrated a 95.7% positive agreement against RT-PCR in samples collected from asymptomatic individuals. Since the Omicron variant shows a much higher rate of asymptomatic carriage compared to other variants, the high sensitivity of the LumiraDx SARS-CoV-2 Ag Ultra test may be an important tool in breaking the chain of transmission.one

Ron Zwanziger, CEO of LumiraDx, explained, “Our SARS-CoV-2 Ag Ultra test exemplifies our mission to increase access to testing and provide rapid diagnostics without sacrificing accuracy. Now doctors, pharmacies and other providers can use a single platform and significantly scale everything up, making a profound impact on patient workflow supported by our Platform. This innovation and advancement of our microfluidic technology can also be applied to other tests on our Platform, which we look forward to launching in the coming year.”

The teacher Jean-Paul Cristol, Head of the Division of Biological Pathology at the University Hospital Center of Montpellier, commented: “The LumiraDx SARS-CoV-2 Ag test has been integrated into the testing strategy in the adult emergency departments, pediatrics, obstetrics and neurology of our institution from this January. Clinical precision allows us to detect symptomatic and asymptomatic patients and the traceability of the results is guaranteed by the connection with our middleware. In the emergency department, time is everything and being able to offer these results in a short time can be essential. A test with high sensitivity, good traceability and faster will be an optimal option to examine patients in the emergency departments”.

The proof SARS-CoV-2 Ag Ultra follows the successful launch of the LumiraDx SARS-CoV-2 Antigen test, which has been commercially available for nearly two years.

About LumiraDx

LumiraDx (Nasdaq: LMDX) is a next-generation point-of-care diagnostics company that is transforming community healthcare. Founded in 2014, LumiraDx manufactures and markets an innovative diagnostic platform that supports a broad menu of tests with performance comparable to that of the point-of-care laboratory. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions in laboratories, urgent care, doctor’s offices, pharmacies, schools and workplaces to assess, diagnose and monitor wellness and disease. LumiraDx has more than 30 tests on the market and under development covering infectious diseases, cardiovascular disease, diabetes and bleeding disorders, all on the LumiraDx platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-effective COVID-19 testing solutions from the lab to the point of need.

LumiraDx is based in the UK with more than 1,600 employees worldwide. For more information about LumiraDx and the LumiraDx Platform visit lumiradx.com

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements about the performance and benefits of the SARS-CoV-2 Ag Ultra test. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to be materially different from information expressed or implied by these forward-looking statements, including, without limitation, economic conditions, general political and business; the effect of COVID-19 on LumiraDx’s business and financial results; the maintenance of the CE mark for the SARS-CoV-2 Ag Ultra test and those factors that are discussed under the heading “Risk Factors” in the Annual Report on Form 20-F for the year ended December 31, 2021, which was filed by LumiraDx with the Securities and Exchange Commission (“SEC”) on April 13, 2022, and other filings made by LumiraDx with the SEC. Although LumiraDx believes that it has a reasonable basis for each forward-looking statement contained in this press release, LumiraDx cautions that these statements are based on a combination of facts and factors currently known to it and its forward-looking projections, on which it cannot rely. safe. LumiraDx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

*Not all tests are available in all countries and regions. For more details on product availability, visit lumiradx.com.

1 Garrett N, Tapley A, Andriesen J, et al. High Rate of Asymptomatic Carriage Associated with Variant Strain Omicron. Preprint. medRxiv. 2022;2021.12.20.21268130. Published January 14, 2022. doi:10.1101/2021.12.20.21268130

Media Contact:
Colleen McMillen
Colleen.McMillen@lumiradx.com

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