bioMérieux received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market VIDAS® NT-proBNP, a test that aids in the diagnosis of suspected congestive heart failure.
Heart failure is a major healthcare issue, whose frequency is expected to continue to rise in the coming years due to the worldwide aging population and increased survival rate from acute coronary events. It is the leading cause of hospitalization in people over 65 years of age, affecting up to 17 million people worldwide.
In the U.S., five million people suffer from
heart failure, and 550,000 new cases are
diagnosed each year1.
VIDAS NT-proBNP (N-terminal fragment of B-type natriuretic peptide) is a quantitative marker of heart stress with the potential to detect all stages of heart failure, even the early stages, which can be difficult to detect. The test provides objective diagnostic information that helps clinicians distinguish heart failure from other disease states with similar clinical symptoms, such as lung diseases or pulmonary embolism. VIDAS NT-proBNP is a proven marker for heart failure and will provide clinicians with a powerful tool for the management of life-threatening cardiac pathologies.
NT-proBNP can also be used to assess the prognosis of patients with established heart failure or acute coronary syndrome. Its measurement is cost-effective and leads to important healthcare cost-savings as shown by analysis from a study at Harvard Medical School’s Brigham and Women’s Hospital in Boston2 and a pivotal randomized multi-center study in Canada3. The latter study reported a reduction in direct medical costs of 15 percent (USD $949 per patient) when NT-proBNP testing was part of routine assessment of emergency department patients with dyspnea (shortness of breath).
bioMérieux Receives FDA Clearance for VIDAS® C. difficile Toxin A&B Assay
bioMérieux is broadening its infectious disease testing panel following clearance from the U.S.
Food & Drug Administration (FDA) for C. difficile Toxin A&B (CDAB), used with the automated
VIDAS® system.
The VIDAS C. difficile Toxin A&B assay offers rapid detection of the C. difficile bacterium, which is the most common cause of antibiotic-associated diarrhea in hospitals. In recent years, the incidence of C. difficile has increased and evolving strains can result in pseudomembranous colitis, sepsis and even death.
The VIDAS C. difficile Toxin A&B test provides results in 75 minutes, enabling physicians to administer proper treatment and prevent unnecessary patient isolation
and outbreaks.
bioMérieux’s VIDAS C. difficile Toxin A&B Assay is the only automated test on the market today, making bioMérieux the first company to offer a complete solution for managing C. difficile infections, including identification with the
API® 20A strip, antibiogram with the ATB™
Anaerobic strip, and bacterial genotyping
with the DiversiLab® system.
bioMérieux receives FDA clearance for VIDAS® Troponin I Ultra Assay
bioMérieux received FDA clearance for Troponin I Ultra Assay, a new emergency panel assay for the VIDAS system. Due to its high sensitivity, VIDAS Troponin I Ultra can aid in the diagnosis of myocardial infarction accurately, even at a very early stage.
The VIDAS Troponin I Ultra enables physicians to diagnose and therefore initiate treatment without delay in patients presenting to emergency departments with symptoms of acute coronary syndrome. Furthermore, the VIDAS Troponin I Ultra is one of the first to comply with the National Institute of Standards and Technology (NIST)’s new Standard Reference Materials (SRM) 2921 (human cardiac troponin complex), which will facilitate the interpretation of results for biologists and
medical practitioners.
The VIDAS Troponin I Ultra assay offers the following benefits:
Easy to use: just load and go
Cost effective single test format
Tests run individually or batched
Gold standard ELISA methodology
Highly reliable: Mean Time Between Failure (MTBF) > two years
FDA Clears bioMérieux’s VIDAS® NT-proBNP Assay
bioMérieux receives FDA clearance for VIDAS® Troponin I Ultra Assay
