LumiraDx has obtained CE mark for its new NT-proBNP test, a rapid and easy to use microfluidic immunofluorescence assay, which is used for diagnosing congestive heart failure (CHF).
The device has been designed for measuring the NT-proBNP levels in human capillary, venous whole blood and plasma samples.
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It provides results in 12 minutes from sample application and helps in monitoring the peptide levels that are raised during many majority forms of heart failure.
The direct fingerstick assay is intended to be used in community-based healthcare settings for accurately and rapidly diagnosing individuals who are suspected of having CHF.
Additionally, the company obtained an updated CE mark for its D-Dimer test which will now include detection of venous thromboembolism (VTE) in symptomatic patients.
The LumiraDx D-Dimer Test is a fluorescence immunoassay which has been designed for measuring D-Dimer levels in human whole blood and plasma at a point of care (POC) setting.
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By GlobalDataThe expanded CE marking will now allow the test to be used, together with a clinical pre-test probability assessment model, for detecting VTE in symptomatic patients.
LumiraDx stated that a prospective clinical trial (EMBOL) was conducted in the UK and Germany, in 618 symptomatic patients.
Findings showed that the LumiraDx D-Dimer test has strong correlation with the laboratory reference method, with 99.5% negative predictive value at the 500ug/L cut off, when used together with a pretest probability score.
LumiraDx CEO Ron Zwanziger said: “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.
“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.”
