Beckman Coulter Diagnostics along with partner Diazyme Laboratories announced FDA clearance of a new procalcitonin (PCT) assay for the management of bacterial infections and sepsis.
Sepsis is the leading cause of death in U.S. hospitals, according to the Sepsis Alliance. More than 1.6 million people in the U.S. are diagnosed with sepsis annually. Sepsis is the number one cost of hospitalization in the U.S. consuming more than $24 billion each year as well as ranking as the top cause for readmissions to the hospital.
"Fast diagnosis and treatment are critical for patients who have become septic," said Mike Samoszuk, M.D., vice president and chief medical officer at Beckman Coulter Diagnostics. "Adding PCT to our chemistry menu offers a tool for managing bacterial infections and sepsis, which should, inform the course and prognosis of the disease and facilitate therapeutic decisions. This addition is a result of our commitment to providing disease-state-management solutions."
The assay features a latex-enhanced immunoturbidimetric methodology, which uses multiple monoclonal antibodies for enhanced assay sensitivity and specificity.
Beckman Coulter has partnered with Diazyme Laboratories to distribute the PCT assay to ensure delivery of the broadest range of solutions for clinical laboratories. Diazyme Laboratories is a cGMP and ISO 13485 certified medical device manufacturer, utilizing proprietary enzyme and immunoassay technologies to develop diagnostic reagents in user-friendly formats.