Medical diagnostics company bioMerieux has received clearance from the FDA for a new clinical diagnostic tool it is developing for cardio-pulmonary diseases.

The tool is known as Vidas D-Dimer New, which is an extended range D-dimer assay to exclude the presence of suspected deep vein thrombosis (DVT) and aid in the diagnosis of pulmonary embolism (PE) in outpatients.

A French company, bioMerieux has its U.S. headquarters in Durham, where it employs 1,500 people.

The FDA clearance elevates Vidas D-Dimer New as a new tool benefiting clinicians, laboratories and the more than 6 million patients per year in North America presenting with symptoms of DVT and PE.

According to the American Heart Association, an estimated two million Americans are affected by DVT and of those, about 60,000 die of PE. These conditions are classified as venous thrombo-embolism (VTE).

Nearly 75 percent of patients suspected of VTE do not have the condition. These patients may be subjected to a series of painful, expensive and potentially risky tests, or may undergo unnecessary treatment, because the condition is difficult to diagnose.

Now, bioMerieux says its Vidas D-Dimer New, coupled with a pretest probability assessment, provides a safer, cost-effective and time-sensitive method to rule out DVT without these other tests.

“Our company is dedicated to providing timely, accurate solutions for laboratories and clinicians to improve patient outcomes while controlling costs,” stated Philipe Sans, president and chief executive officer of bioMerieux USA. “Vidas D-Dimer New provides a timely, safe, and reliable result and is the only — test on the market cleared for use in exclusion of DVT.”