bioMerieux Receives FDA Approval for Infection Risk Test
bioMerieux, a French pharmaceutical firm with a major operation in Durham, has received U.S. Food and Drug Administration approval to sell its infection risk test in the U.S.
The product, called VIDAS B R A H M S PCT, is an automated test measuring biological markers that indicate bacterial infections that lead to sepsis and septic shock. The test will be used for critically ill patients who are admitted to intensive care units. It will help care providers assess the patients’ risk of developing sever sepsis and septic shock.
bioMerieux is the first company in the U.S. to offer the automated test. It was launched in Europe in March.
The bioMerieux VIDAS platform also offers measurements of other potential problems such as cardiac necrosis.
"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," said Stéphane Bancel, chief executive officer at bioMérieux. "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.”...
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