LumiraDx has received a CE mark for its new rapid microfluidic immunofluorescence assay, dubbed LumiraDx NT-proBNP test, to aid the diagnosis of congestive heart failure (CHF).
It is designed to detect the levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human venous whole blood and plasma samples and provide results within 12 minutes from sample application.
The direct fingerstick assay is intended for use in community-based healthcare settings to rapidly and accurately diagnose individuals suspected of having CHF, said the company.
In addition, the diagnostics company has obtained an expanded CE mark approval for its D-Dimer test to include the detection of venous thromboembolism (VTE) in symptomatic patients.
D-Dimer is a protein fragment present in the blood after a blood clot is degraded by fibrinolysis, and its testing is the first step in the management of patients suspected of VTE.
With the expanded approval, the LumiraDx D-Dimer test is now allowed for use, together with a clinical pre-test probability assessment model, to detect VTE in symptomatic patients.
The point of care (POC) test runs on the same platform as the company’s 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.
The EMBOL trial, conducted in the UK and Germany, in 618 symptomatic patients showed that the LumiraDx D-Dimer test has a strong correlation with the laboratory reference method.
The test showed a 99.5% negative predictive value at the 500ug/L cut off when used in combination with a pretest probability score.
LumiraDx chief executive officer 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.”
LumiraDx is already commercialising its D-Dimer test across Europe, and its NT-proBNP test is expected to be available in Europe later this year.
Last month, the diagnostics company secured CE marking for its HbA1c test, and its five-minute SARS-CoV-2 antigen test, and received the Emergency Use Listing (EUL) from the World Health Organization (WHO) for its SARS-CoV-2 Ag Test.
