LumiraDx HbA1c Test Achieves CE Mark, Addresses Growing Global Need for Diabetes Screening and Monitoring with its Next-Generation Point of Care Diagnostic Platform

Rhea-AI Summary

LumiraDx Limited (Nasdaq: LMDX) announced that its HbA1c test has received CE Marking, enabling rapid monitoring for diabetes. The automated fingerstick assay, part of the LumiraDx Platform, delivers results in under seven minutes, addressing the increasing need for accessible HbA1c testing in community healthcare. With global diabetes-related healthcare expenditures soaring to USD 966 billion in 2021, this test aims to improve patient management and streamline testing processes for clinicians. The platform also includes tests for various conditions, ensuring comprehensive healthcare solutions.

Positive

• CE Marking for the HbA1c test expands the product offering.
• Rapid results in under seven minutes enhance patient care.
• Addresses the growing global demand for diabetes screening and monitoring.

Negative

• Market competition may affect adoption of the new test.
• Reliance on maintaining CE marking for commercialization.

• Rapid microfluidic immunofluorescence assay intended for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes
• The automated, quantitative fingerstick assay is run on the highly portable LumiraDx Platform and designed for near-patient testing with connected results in under seven minutes
• Rising global rates of diabetes presents growing need for broader access and an easier, more connected solution for HbA1c testing in community-based healthcare settings such as primary care and retail pharmacy
• Available on the same Point of Care (POC) Platform as LumiraDx's high sensitivity SARS-CoV-2 Antigen, Flu A/B, RSV, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool, SARS-CoV-2 Ag Ultra as well as INR, D-Dimer and CRP tests*

LONDON, May 26, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its HbA1c test has achieved CE Marking. Used with the LumiraDx Platform, the test provides results in under seven minutes from sample application for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes, all at the point of care.

The addition of HbA1c to the LumiraDx test menu, enables the consolidation of multiple instruments to a single, next generation POC Platform with a common workflow. The LumiraDx HbA1c test has a reportable range of 20 - 130 mmol/mol HbA1c (4.0 - 14.0% HbA1c). In an external, multi-site clinical study, the test achieved precision, expressed as mean paired replicate %CV, of ≤2.50% in both capillary and venous whole blood. The LumiraDx HbA1c test is designed to address the growing clinical need for accessible and reliable HbA1c testing in the community healthcare setting.

Ron Zwanziger, LumiraDx's Chief Executive Officer commented, "With our growing test menu, the LumiraDx Platform is able to quickly and accurately support clinicians with a variety of diagnostic and treatment decisions at the point of care. HbA1c is an important addition to our Platform not only for our existing pharmacy and primary care customers, but for new customers looking to consolidate their current testing needs into one centralized and streamlined, connected Platform that delivers lab comparable performance."

The increase in global health expenditure due to diabetes has been considerable in recent years, growing from USD 232 billion in 2007 to USD 966 billion in 2021 for adults aged 20–79 years – an increase of 316% over the last 15 years¹. By offering both broader access and an easier, more connected solution for HbA1c testing, patients who might be at risk of developing diabetes may begin to manage their condition sooner, potentially leading to less strain on healthcare systems.

About LumiraDx

LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. LumiraDx has, on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 testing solutions from the lab to point of need.

LumiraDx is based in the UK with more than 1600 employees worldwide. Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding the performance and benefits of the LumiraDx HbA1c 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 the information expressed or implied by these forward-looking statements, including, among others, general economic, political and business conditions; regulatory changes; the ability of LumiraDx to maintain CE marking for its HbA1c test; and those factors discussed under the header "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 you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain. 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 additional detail on product availability please visit www.lumiradx.com.

1. IDF Diabetes Atlas, 10^th Edition - 2021

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

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SOURCE LumiraDx

FAQ

What is the LumiraDx HbA1c test and its significance for LMDX?

The LumiraDx HbA1c test, which achieved CE Marking, allows for rapid diabetes monitoring and has the potential to improve patient management in community healthcare settings.

How does the LumiraDx Platform improve diabetes testing?

The LumiraDx Platform offers an automated, quantitative fingerstick assay that delivers results in under seven minutes, streamlining the HbA1c testing process.

What are the implications of CE Marking for LMDX's HbA1c test?

Achieving CE Marking enables LumiraDx to market the HbA1c test in Europe, potentially increasing its reach and revenue in the healthcare diagnostics market.

What is the current market demand for diabetes testing solutions from LMDX?

With global diabetes healthcare expenditures reaching USD 966 billion in 2021, there is a significant demand for accessible HbA1c testing solutions.

What types of tests are available on the LumiraDx Platform?

The LumiraDx Platform includes a variety of tests such as SARS-CoV-2 Antigen, Flu A/B, and others alongside the new HbA1c test.