Test for Sepsis Ready for U.S. Market
BioMerieux received FDA clearance for their new sepsis test used to assess infections in both tissue and blood specimens, the VIDAS BRAHMS. The approval was announced with a press release.
The intent of the test is to evaluate patients upon admission to the intensive care setting. The test is utilized to evaluate the likelihood that patients will progress from severe sepsis to septic shock.
This is the first U.S. launch of an automated test that measures the level of procalcitonin (PCT). PCT is a biomarker of bacterial infections and can help identify patients with sepsis. The test has already been used extensively across Europe.
The VIDAS BRAHMS is particularly useful as a means to support efforts for early intervention. Earlier detection of disease allows commencement of treatment at the earliest stage of disease, which ensures the best outcomes for patients. Early intervention particularly improves the likelihood of survival following sepsis.
The laboratory test system provides rapid results that can be delivered within 20 minutes. BioMerieux has an existing panel of tests utilized emergently, the VIDAS BRAHMS is added to those. Other emergent tests include assessment of markers for venous thromboembolism, the VIDAS D-DIMER Exclusion, and cardiac necrosis, the VIDAS Troponin I CK-MB.
Sepsis is the leading cause of death in non-cardiac intensive care settings. The mortality rate is 32 percent for severe sepsis and 54 percent for septic shock. Over 750,000 people develop sepsis every year.
October 22, 2007 Related topics: Laboratory, Infectious Diseases, Product Approval & Certification, Diagnostic