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LumiraDx Gets New, Expanded CE Marks for Point-of-Care Cardiovascular Disease Tests

NEW YORK – LumiraDx said on Thursday that it has received CE marking for its NT-proBNP test for diagnosing congestive heart failure (CHF), as well as an updated CE mark for its D-dimer test.

The LumiraDx NT-proBNP uses fingerstick blood samples to monitor levels of peptides that are elevated in most forms of CHF, providing results in 12 minutes, LumiraDx said. It is designed for use in community-based healthcare settings.

Lumira's CE-marked D-Dimer test is designed to quantify D-dimer levels in fingerstick blood and plasma samples at the point of care to help in the assessment and diagnosis of patients with suspected venous thromboembolism (VTE) including deep vein thrombosis (DVT) pulmonary embolism (PE). With the expanded CE marking, the test — which provides results within six minutes — may now be used in conjunction with a clinical pretest probability assessment model to exclude DVT and pulmonary embolism disease in symptomatic patients, LumiraDx said.

Both tests run on the London-based company's LumiraDx point-of-care platform.

"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," LumiraDx CEO Ron Zwanziger said in a statement. "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."

Last month, LumiraDx received CE marking for an HbA1c test.