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LumiraDx Announces Commercial Shipment of its Point of Care NT-proBNP Test in Europe, Supporting Heart Health Checks in UK

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LumiraDx Limited (Nasdaq: LMDX) has announced the commercial launch of its fingerstick NT-proBNP test, designed for rapid diagnosis of congestive heart failure (CHF). This innovative test, which provides lab-comparable results in just 12 minutes, is the first of its kind available for near-patient testing. The launch is supported by a partnership with Medtronic and local healthcare trusts in the UK through the 'Your Heart Matters Bus' initiative, offering free heart health checks. The company aims to enhance community-based healthcare by facilitating easier access to critical diagnostics.

Positive
  • Launch of the NT-proBNP test enhances diagnostic capabilities for CHF.
  • Partnership with Medtronic for community health initiative may improve public health outreach.
Negative
  • None.
  • Run on the highly portable LumiraDx Platform, the LumiraDx NT-proBNP test is a quantitative, fingerstick blood assay designed for near-patient testing with lab-comparable results in 12 minutes. It is the only fingerstick NT-proBNP test currently commercially available.
  • The LumiraDx NT-proBNP test is a rapid microfluidic immunofluorescence assay that can aid in the diagnosis of congestive heart failure (CHF).
  • Available on the same point of care (POC) Platform as LumiraDx’s high sensitivity SARS-CoV-2 antigen, HbA1c, D-Dimer, INR, CRP, Flu A/B, RSV, SARS-CoV-2 antibody, SARS-CoV-2 antigen pool, SARS-CoV-2 Ag Ultra and Ultra Pool tests.*
  • LumiraDx is partnering with Medtronic and a number of local healthcare trusts and charities in the UK to launch the Your Heart Matters Bus initiative where members of the public will be offered free heart health checks, LumiraDx NT-proBNP test results as indicated and medical information through a mobile walk-on service.

LONDON, Jan. 31, 2023 (GLOBE NEWSWIRE) -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced it has commenced commercial shipment of its point of care NT-proBNP test to aid in the diagnosis of CHF across Europe.

The LumiraDx NT-proBNP direct fingerstick assay monitors levels of peptides elevated in the majority forms of heart failure and provides results in twelve minutes from sample application. It is designed to provide lab comparable performance in community-based healthcare settings to quickly and accurately aid in the diagnosis of individuals suspected of having congestive heart failure.

The LumiraDx NT-proBNP test is currently the only quantitative direct fingerstick NT-proBNP assay commercially available, which can enable access to NT-proBNP testing in the community.

To illustrate how the LumiraDx Platform is helping to transform community-based healthcare, LumiraDx is partnering with Medtronic and a number of local healthcare trusts and charities in the UK to launch the Your Heart Matters Bus initiative where members of the public will be offered free heart health checks through a mobile walk-on service. The initiative launches on February 1st and, as part of the initiative, the LumiraDx NT-proBNP point of care test will be used with the members of public who are recommended a test by the healthcare professional at the walk-on service.

Ron Zwanziger, CEO of LumiraDx explains, “As the disease burden of heart failure continues to grow across developed countries, there is a push to optimise diagnosis and care for patients in the community. POC testing is fast and accessible, making implementation in primary care more efficient than laboratory testing. The innovative fingerstick application of the LumiraDx NT-proBNP test will greatly facilitate the switch to NT-proBNP testing in the community, with the potential to transform the diagnosis of heart failure with earlier detection and intervention. The Your Heart Matters Bus initiative is a perfect example of how the LumiraDx technology can truly bring lab comparable diagnostics to the community.”

About LumiraDx

LumiraDx Limited (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Its actively controlled microfluidic technology provides fast, high performance and accessible diagnostic solutions wherever the patient is for nearly any testing scenario, creating unique testing options at the point of need.

The company offers a broad menu of lab comparable tests on a single portable Platform, with more than 30 assays on the market and in the pipeline, covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders. The company also supports high-complexity laboratory testing in an accessible high-throughput format to leverage current molecular laboratory operations.

Founded in 2014 and based in the UK, LumiraDx's diagnostic testing solutions are being deployed globally by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to help screen, diagnose, and monitor wellness as well as disease. More information on LumiraDx 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 benefits and performance of the LumiraDx NT-proBNP 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; changes in interest rates, inflation rates and global and domestic market conditions; the effect of COVID-19 on LumiraDx's business and financial results; obtaining or maintaining regulatory approval, authorization or clearance for our tests; and those factors discussed under the header "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2021, which was filed with the Securities and Exchange Commission, or SEC on April 13, 2022, in our report on Form 6-K that was filed with the SEC on August 16, 2022, and in other filings that we make 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.


FAQ

What is the LumiraDx NT-proBNP test?

The LumiraDx NT-proBNP test is a fingerstick blood assay for rapid diagnosis of congestive heart failure, providing results in 12 minutes.

When was the LumiraDx NT-proBNP test launched?

The commercial shipment of the LumiraDx NT-proBNP test commenced on January 31, 2023.

How does the NT-proBNP test benefit patient care?

The test provides rapid, lab-comparable results, enabling quicker diagnosis and potential earlier intervention for patients suspected of heart failure.

What is the 'Your Heart Matters Bus' initiative?

It is a partnership initiative by LumiraDx and Medtronic offering free heart health checks to the public through a mobile service.

Where is the LumiraDx NT-proBNP test available?

The test is currently available across Europe, particularly through community healthcare settings.

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