LumiraDx Expands its Cardiovascular Testing Portfolio with CE Marking of its NT-proBNP Test and new Exclusion Claim for its D-Dimer Test

Rhea-AI Summary

LumiraDx Limited (Nasdaq: LMDX) has expanded its cardiovascular testing portfolio by receiving a CE Mark for its NT-proBNP test to assist in diagnosing congestive heart failure (CHF) and an updated CE Mark for its D-Dimer test, which now allows clinicians to rule out venous thromboembolism (VTE) in symptomatic patients. Both tests, designed for near-patient testing, provide rapid results—12 minutes for NT-proBNP and 6 minutes for D-Dimer—using a simple fingerstick sample. The D-Dimer test showcases a 99.5% negative predictive value when combined with a pre-test probability score.

Positive

• CE Marks received for NT-proBNP and D-Dimer tests enhance LumiraDx's testing portfolio.
• Rapid results of 12 minutes (NT-proBNP) and 6 minutes (D-Dimer) improve patient assessment efficiency.
• D-Dimer test demonstrates 99.5% negative predictive value, potentially streamlining VTE management.

Negative

• Dependence on regulatory approvals for continued market presence and commercialization.
• Market competition in cardiovascular testing may impact future sales and market share.

• The LumiraDx NT-proBNP and the LumiraDx D-Dimer tests are currently the only quantitative direct fingerstick assays produced for each test. Run on the highly portable LumiraDx Platform, they are designed for near-patient testing with connected results in 12 minutes and 6 minutes, respectively 
• The LumiraDx NT-proBNP test is a rapid microfluidic immunofluorescence assay for the quantitative measurement of NT-proBNP in human capillary, venous whole blood and plasma specimens. It is intended to be used as an aid in the diagnosis of congestive heart failure (CHF)
• With its new Exclusion Claim, the LumiraDx D-Dimer test may be used at the point of care (POC), in conjunction with a clinical pre-test probability assessment model, to allow clinicians to rule out venous thromboembolism (VTE) in symptomatic patients
• Available on the same 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 and Ultra Pool as well as HbA1c, INR, and CRP tests*

LONDON, June 2, 2022 /PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced it has expanded its cardiovascular offering with a CE Mark for its new NT-proBNP test to aid in the diagnosis of CHF and an updated CE Mark for its D-Dimer test to now rule out venous thromboembolism (VTE) in symptomatic patients. With these two additions, the LumiraDx Platform can further support clinicians in quickly and accurately assessing patient symptoms for both VTE and heart failure at the point of care.

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 for use in community-based healthcare settings to quickly and accurately aid in the diagnosis of individuals suspected of having congestive heart failure.

D-Dimer testing is widely accepted as the first step in the management of patients suspected of VTE. The LumiraDx D-Dimer test may now be used in conjunction with a clinical pre-test probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in symptomatic patients.¹A prospective clinical study (EMBOL) conducted in the UK and Germany with 618 symptomatic patients presenting in the Emergency department and Ambulatory clinic settings, demonstrated that the LumiraDx D-Dimer test has a strong correlation with the laboratory reference method with 99.5% negative predictive value at the 500 ug/L cut off, when used in combination with a pretest probability score. EMBOL is the first study to prospectively demonstrate the use of a quantitative fingerstick D-Dimer test at POC to rule out VTE in symptomatic patients, which has the opportunity to significantly improve primary care assessment by physicians and also potentially reduce the time of the patient's hospital visit, as well as follow up testing.

Ron Zwanziger, LumiraDx's Chief Executive Officer commented, "The new and updated CE Marks for our NT-proBNP and D-Dimer tests represent an important advancement in cardiovascular testing in the point of care space. Healthcare systems in Europe and globally are looking to shift care from centralized hospital settings to community settings. Our new tests deliver results in minutes from an easy-to-collect fingerstick sample, allowing fast and accurate management of cardiovascular conditions by first responders, primary care, urgent care, and the emergency department. Being able to do this at the point of care can improve patient pathways, reduce strains on health systems, specifically emergency departments and lead to improved patient outcomes." 

The LumiraDx D-Dimer test is commercially available across Europe. The LumiraDx NT-proBNP test is expected to begin commercialization later this year.

*  Not all tests are available in all countries and regions. For additional detail on product availability please visit www.lumiradx.com.

1. Rodger MA, Le Gal G, Wells P et al. Clinical decision rules and D-Dimer in venous thromboembolism: current controversies and future research priorities. Throm Res 2014; 134,4: 763-68

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 NT-proBNP and D-Dimer tests, and the expected commercialization timeline for 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; regulatory changes; the ability of LumiraDx to maintain CE marking for its NT-proBNP and D-Dimer tests; 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 in 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, except as required by applicable law.

Media Contact:
Colleen.McMillen@lumiradx.com 

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SOURCE LumiraDx

FAQ

What is the significance of the CE Mark for LumiraDx's NT-proBNP test?

The CE Mark indicates that the NT-proBNP test meets European health and safety standards, allowing it to be marketed in Europe for aiding in the diagnosis of congestive heart failure.

How does the D-Dimer test from LumiraDx work?

The D-Dimer test is a quantitative fingerstick assay used at the point of care to rule out venous thromboembolism in symptomatic patients when combined with a clinical pre-test probability assessment.

What are the expected impacts of LumiraDx's new tests on patient care?

The new tests enable faster and more accurate diagnostics at the point of care, potentially improving patient outcomes and reducing the strain on healthcare systems.

When is the LumiraDx NT-proBNP test expected to be commercially available?

The NT-proBNP test is anticipated to begin commercialization later this year.

What clinical study supports the D-Dimer test's effectiveness?

The EMBOL study conducted in the UK and Germany showed a high correlation with laboratory reference methods, establishing the D-Dimer test's negative predictive value.