LumiraDx CRP Test Achieves CE Marking

Rhea-AI Summary

LumiraDx (Nasdaq: LMDX) announced that its C-reactive protein (CRP) Test has received CE Marking, allowing it to be marketed in the European Union. This portable, fully automated test provides results within four minutes, facilitating the diagnosis of infections and inflammation. Particularly useful in assessing respiratory infections, the test can help reduce unnecessary antibiotic use, addressing antimicrobial resistance concerns. Shipments are set to begin shortly, following the company's recent CE marking for its SARS-CoV-2 & Flu A/B Antigen Test.

Positive

• CE Marking approval for the LumiraDx CRP Test enhances marketability in the EU.
• The test provides quick results (within four minutes) for effective clinical decision-making.
• Addresses the pressing issue of antimicrobial resistance by reducing unnecessary antibiotic prescriptions.
• The integration of CRP testing with existing COVID-19 and Flu A/B tests on the LumiraDx Platform offers comprehensive patient assessment tools.

Negative

• None.

LONDON, Jan. 11, 2022 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its C-reactive protein (CRP) Test has achieved CE Marking. The LumiraDx CRP Test is a small, portable, fully automated, microfluidic immunoassay test used for the quantitative determination of C-reactive protein with results within four minutes. The measurement of CRP provides important information for the detection and evaluation of infection, and inflammation. In patients with respiratory infection symptoms, especially suspected pneumonia¹, significantly high CRP suggests the need for antibiotic treatment, whereas normal or low CRP levels suggest patients have viral or self-limiting infection that does not require antibiotics.

The LumiraDx CRP Test accurately measures direct fingerstick, venous whole blood, and plasma samples within a range of 5.0 - 250.0 mg/L. The assay is run on the LumiraDx Platform, which can be used at the patient side in primary and community care, patient homes and in hospital emergency care settings providing fast, reliable test results for timely decision making.

Clinicians can use the LumiraDx CRP test in the assessment of infection, tissue injury, and inflammatory conditions. Insights from the test can also provide valuable information to reduce unnecessary antibiotic prescribing, in an overall effort to fight antimicrobial resistance. In fact, while the consumption of antibiotics in England declined during the pandemic²,  recent studies have highlighted high rates of antibiotic prescribing among COVID-19 patients³ illustrating the unnecessary use of antibiotics and fear that antibiotic-resistant infections may return to pre-pandemic levels.²

"Antimicrobial resistance is a growing concern across the globe, and if left unaddressed will lead to a serious public health crisis. While the causes of antimicrobial resistance are complex, growing evidence suggests that improving the clinical diagnosis of respiratory infections in patients is a key component in tackling unnecessary antibiotic prescribing rates," says Professor Jonathan Cooke, visiting Professor in the Department of Surgery and Cancer, Faculty of Medicine at Imperial College London. "Having access to rapid CRP-POCT diagnostic tools has been shown to support healthcare providers when making prescribing decisions and helps improve the management of respiratory infections."

Ron Zwanziger, LumiraDx Chairman and CEO explained, "The addition of CRP onto the LumiraDx Platform will be critical this respiratory season to provide clinicians with a variety of tools to aid in the assessment of patients and their need for antibiotic treatment. Including the assay on the LumiraDx platform along with our COVID-19 and Flu A/B tests will enable clinicians to make important treatment decisions at the point of care."

Shipments of the LumiraDx CRP Test will begin shortly. The announcement comes on the heels of the company announcing the CE Mark for the LumiraDx SARS-CoV-2 & Flu A/B Antigen Test just last month.

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 CRP Test and LumiraDx Platform. 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; the effect of COVID-19 on LumiraDx's business and financial results; maintaining regulatory approval or clearance of tests; and those factors discussed under the header "Risk Factors" in the Proxy Statement and Prospectus filed pursuant to Rule 424B(3) with the Securities and Exchange Commission ("SEC") on September 10, 2021 and other filings 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.

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

References

1. Guidelines for the management of adult lower respiratory tract infections – Summary, Clinical Microbiology and Infection, 2011
2. English surveillance programme for antimicrobial utilisation and resistance (ESPAUR), Report 2020 to 2021
3. Westblade, LS et al. Bacterial Coinfections in Coronavirus Disease 2019. Trends in Microbiology, 2021, Vol. 29, No. 10

 

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SOURCE LumiraDx

FAQ

What is the significance of the CE Marking for LumiraDx's CRP Test?

The CE Marking allows LumiraDx's CRP Test to be sold within the European Union, significantly broadening its market potential.

How quickly does the LumiraDx CRP Test provide results?

The LumiraDx CRP Test provides results within four minutes, enabling rapid clinical decision-making.

What role does the LumiraDx CRP Test play in managing antibiotic prescriptions?

The CRP Test helps clinicians determine the need for antibiotics in respiratory infections, potentially reducing unnecessary prescriptions.

When will the LumiraDx CRP Test be available for shipment?

Shipments of the LumiraDx CRP Test are set to begin shortly after receiving CE Marking.

What other tests are available on the LumiraDx Platform?

In addition to the CRP Test, the LumiraDx Platform includes tests for COVID-19 and Flu A/B, among others.