Heart Failure Test Approved
bioMerieux received 501(k) clearance from the Food and Drug Administration for a new diagnostic test for heart failure. A press release was posted on the company’s website describing the approval.
The Vidas NT-proBNP (N-terminal pro-B type natriuretic peptide) test provides a quantitative assessment of heart stress. The test is further capable of detecting heart failure at all stages, even during early disease. Early stage disease can be difficult to detect and this new modality provides an additional means to evaluate such. The assay can be completed 24 hours a day in the emergency room setting.
Information provided by the test aids clinicians in diagnosis of this condition and can distinguish heart failure from other disease states. Other conditions that may fall into a differential diagnosis with heart failure that need to be ruled out or include pulmonary embolism and lung disease.
The Vidas test also provides clinicians with prognostic information for those patients who are diagnosed with either acute coronary syndrome or heart failure. Data indicates that this test is cost-effective and can provides important cost savings in the healthcare industry.
Cost-effectiveness data is based on studies completed by Brigham and Women’s Hospital and a trial completed in Canada. Direct medical reports indicate a 15 percent reduction in costs when the Vidas NT-proBNP was included in initial assessment of patients that presented to the emergency room with dyspnea.
Other tests available from bioMerieux used in the emergency room to evaluate patients are included in the company’s Vidas Emergency Panel. Tests included are the Vidas Triponin I, which measures cardiac necrosis, the Vidas D-Dimer Exclusion for venous thromboembolism, and the Vidas Brahms PCT, which is used to evaluate patients for bacterial infection.
Heart failure is the main cause of hospitalization in the United States for people over age 65. Over 17 million people across the world have heart failure and 5 million people in the U.S. have this condition. Over half a million new cases are diagnosed every year.
March 27, 2008 Related topics: Product Approval & Certification, Diagnostic