Procalcitonin (PCT) Immunoassay is Sustained on VIDAS® Instruments
Marcy l'Etoile, France and Hennigsdorf, Germany – bioMérieux and Thermo Fisher Scientific Inc., the world leader in serving science, today announced they have renewed their non-exclusive, long-term, royalty-bearing agreement for Procalcitonin (PCT) testing. This agreement extends a long-standing relationship between the companies for biomarker testing using Thermo Fisher’s PCT product on bioMérieux’s VIDAS® and mini VIDAS® immunoassay platforms, and now also includes the new-generation VIDAS® products.
The PCT biomarker test is the gold standard for the early detection of sepsis in critically ill patients. In Europe, the test helps doctors make an early determination whether an infection is bacterial or viral and provides information on the severity of a patient’s condition for appropriate treatment. In the United States, the PCT test is marketed for use on the first day of ICU admission, and, combined with other laboratory tests and clinical assessment, aids in risk assessment of critically ill patients for progression to severe sepsis and septic shock. Broader availability of PCT testing for diagnosing sepsis will lead to improved hospital management and patient care.
“The continuation of our close collaboration with bioMérieux and the installed base of VIDAS® equipment worldwide significantly strengthen our ability to make PCT testing available to a broader patient population,” said Marc Tremblay, president of Thermo Fisher Scientific’s Clinical Diagnostics business. “Earlier detection of sepsis improves patient care and reduces treatment costs. It will also provide a much needed boost to hospitals struggling to maintain service levels and remain competitive.”
“As the world leader in microbiology, bioMérieux has a long-standing commitment to the prevention and management of sepsis through dedicated diagnostic solutions and educational initiatives,” added Jean-Luc Belingard, chairman and CEO of bioMérieux. “Thermo Scientific’s B·R·A·H·M·S PCT biomarker has represented a breakthrough in the field of sepsis and we are pleased to continue to work with them to make their high medical value biomarker available to a greater number of clinicians on our VIDAS® system.”
VIDAS® B·R·A·H·M·S PCT is available worldwide, and bioMérieux received 510(k) clearance from the U.S. Food and Drug Administration for the assay in 2007. The VIDAS® platform has the largest installed base worldwide in immunoassay laboratories and is well-suited to emergency situations.
Severe sepsis strikes more than 750,000 Americans each year, and between 28 to 50 percent of patients affected die within the first month of diagnosis. Hospital costs to treat severe sepsis in the U.S. are estimated at $16 billion dollars annually1. Much of this cost is attributed to misdiagnosis or delayed diagnosis, making rapid, more reliable detection a national, if not global, imperative. Research published in Critical Care Medicine showed that each hour of delay in therapy can decrease chances of patient survival by 7.6 percent 2.
References
[1] Angus DC, Linde-Zwirble WT,; Crit Care Med. 2001 Jul;29(7):1303-10
[2] Kumar A, Roberts D,; Crit Care Med. 2006 Jun;34(6):1589-96.
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