Beckman Coulter Diagnostics Receives CE Mark and Expands Chemistry Menu to include Procalcitonin (PCT)

Automated chemistry assay offers a tool for the diagnosis and management of life-threatening bacterial sepsis

BREA, Calif. — (April 20, 2017) — Beckman Coulter Diagnostics announced a partnership with Diazyme Laboratories that allows customers access to a procalcitonin (PCT) assay, an important marker for the detection and management of bacterial infections and sepsis. The high-quality, fully automated PCT assay is available for use with Beckman Coulter AU analyzers, models 480, 680 and 5800.

Sepsis begins outside of the hospital for nearly 80% of patients. A Centers for Disease Control and Prevention evaluation found seven in ten patients with sepsis had recently used health care services or had chronic diseases requiring frequent medical care.

“Fast diagnosis and treatment is 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 detecting and 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.”

This assay is the first homogenous PCT assay for use on current Beckman Coulter AU model chemistry analyzers eliminating the need for costly dedicated instrumentation. The assay features a latex-enhanced immunoturbidimetric methodology, which uses multiple monoclonal antibodies for enhanced assay sensitivity and specificity.

“Healthcare providers face challenges in timely diagnosis of bacterial infections and sepsis,” said Jack Zakowski, PhD, FACB, director of scientific affairs at Beckman Coulter. “Our AU analyzers are known for high performance, speed and accuracy. Combining our chemistry systems with this PCT assay results in fast turnaround times, and enables rapid assessment of patients in these critical situations.”

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.

Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. For over 80 years, Beckman Coulter has been the partner of choice for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers' mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.