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Diagnostics FDA

 News Release - October 18, 2007

FDA Clears bioMerieux's VIDAS(R) B.R.A.H.M.S PCT(R) Assay

A First Indication for Sepsis Risk Assessment in the ICU

MARCY L'ETOILE, France--(HSMN NewsFeed)--bioMérieux (Paris:BIM ), a world leader in the field of in vitro diagnostics, has received 510(k) clearance from the U.S. Food and Drug Administration to market VIDAS® B.R.A.H.M.S PCT®. The test will be used with critically ill patients on their first day of admission to the Intensive Care Unit (ICU) as an aid to assess their risk for progression to severe sepsis and septic shock.

bioMérieux is the first company in the U.S. to launch an automated test measuring procalcitonin (PCT), a biological marker for bacterial infections. As the progression of severe bacterial infections is affected by how early the patient receives appropriate treatment, measuring PCT levels is valuable in ICUs where sepsis represents a major health challenge. PCT is well-known in Europe, where it is used in numerous hospitals and healthcare settings. VIDAS® B.R.A.H.M.S PCT® was launched in Europe in March of this year.

"Sepsis is a key area of focus for bioMérieux and we are pleased to make this high medical value test available to a great number of clinicians on our widely installed VIDAS® platform," stated Stéphane Bancel, bioMérieux Chief Executive Officer. "PCT testing can be used as an aid to provide an early indication of need for aggressive interventions and can potentially improve patient outcome and increase chances of survival," he added.

The VIDAS® platform is well-suited to emergency situations, with VIDAS® B.R.A.H.M.S PCT® providing test results in just 20 minutes. The new test completes the large VIDAS® Emergency Panel available in the U.S., which includes markers of cardiac necrosis (VIDAS® Troponin I, CK-MB) and Venous Thromboembolism (VIDAS® D-Dimer Exclusion™).

About Sepsis

Sepsis is a complex clinical syndrome that is defined as the systemic inflammatory response of the body to an infection. It is the most common underlying cause of death in non-coronary ICUs where the mortality rate can be as high as 32 percent or 54 percent in case of severe sepsis or septic shock, respectively (1). Every year, severe sepsis (i.e. sepsis complicated by organ dysfunction) strikes an estimated 751,000 people in the U.S. alone with a total cost to the healthcare system of USD 16.7 billion (2). Mainly as a result of the aging of the population, the incidence of severe sepsis in the U.S. is expected to rise to close to 1 million by the end of the decade (2). Early recognition of sepsis and timely initiation of appropriate therapy is key for survival from this potentially devastating condition (3).

About Procalcitonin (PCT)

PCT is the prohormone of calcitonin and is not normally present in the bloodstream of a healthy individual. PCT is released from multiple organs when there is a systemic bacterial infection. The blood plasma level of PCT is a reflection of the severity of bacterial infection, ranging from slightly elevated concentrations in infections with minor systemic inflammatory response to very high values in cases of severe sepsis and septic shock. Since the first report in 1993 on the association of serum PCT levels with bacterial infection (4) there is a solid body of evidence in the literature on its utility for early diagnosis and prognosis, monitoring the clinical course as well as its utility to guide therapy (5).

References

1. Vincent J-L, Sakr Y, Sprung CL, et al. Sepsis in European intensive care units: Results of the SOAP study. Crit Care Med 2006; 34: 344-355.

2. Angus DC, Linde-Zwirble WT, Lidicker J, et al. Epidemiology of severe sepsis in the United States: Analysis of incidence, outcome, and associated costs of care. Crit Care Med 2001; 29: 1303-1310.

3. Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for the management of severe sepsis and septic shock. Crit Care Med 2004; 32: 858-873.

4. Assicot M, Gendrel D, Garsin H, et al. High serum procalcitonin concentrations in patients with sepsis and infection. Lancet 1993; 341: 515-518.

5. Christ-Crain M, Müller B. Procalcitonin in bacterial infections – hype, hope or more or less? Swiss Med Wkly 2005; 135: 451-460.

About bioMérieux

Advancing Diagnostics to Improve Public Health

A world leader in the field of in vitro diagnostics for over 40 years, bioMérieux is present in more than 150 countries through 35 subsidiaries and a large network of distributors. In 2006, revenues reached €1.037 billion with 83% of sales outside of France.

bioMérieux provides diagnostic solutions (reagents, instruments, software) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Our products are used for diagnosing infectious diseases and providing high medical value results for cardiovascular emergencies and cancer screening and monitoring. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products. bioMérieux is listed on Eurolist by Euronext.

For more information, visit: www.biomerieux.com.


Source: bioMerieux

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