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Devices Diagnostics FDA

 News Release - January 28, 2020

Beckman Coulter's Access PCT Procalcitonin Assay Receives U.S. FDA 510(k) Clearance

The Access PCT strengthens industry's most extensive portfolio of in-vitro diagnostic testing for sepsis identification and management

BREA, Calif., Jan. 28, 2020 -- (Healthcare Sales & Marketing Network) -- Beckman Coulter, a global leader in clinical diagnostics, today announced that its Access PCT assay has received FDA 510(k) clearance and is now available for sale in the United States. The sensitivity of the Access PCT assay helps physicians assess critically ill patients in danger of progression to severe sepsis or septic shockówith test results available in under 20 minutes.

"When it comes to sepsis, every minute counts. Bringing the Access PCT Assay into our core laboratory automated workflow makes it possible to streamline procalcitonin testing into our routine service to clinical teams," said Dr. Bernard C. Cook, Ph.D., Chemistry Division Head and Director of Automated Core Laboratory Operations at Henry Ford Hospital in Detroit, Michigan. "In addition, our early evaluations confirmed that the assay has the accuracy and low-end sensitivity needed to help clinicians determine the best treatment options for patients with sepsis and other infections."

Despite advances in modern medicine, sepsis remains the primary cause of death from infection, affecting more than 30 million people worldwide each year1.

"Procalcitonin levels in blood have been found to correlate with the severity of bacterial infections, and also with the probability of a positive blood culture, making it a clinically useful marker in the assessment of patients with possible sepsis or at risk of progressing to septic shock. The ability to rapidly diagnose suspected sepsis patients and determine care and treatment is critical, as earlier administration of appropriate antibiotics is highly correlated with increased patient survival," said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter.

The Access PCT assay enables healthcare providers to integrate procalcitonin testing analysis into their routine sepsis workups on core laboratory analyzers, as a primary or reflex test programmed though Beckman Coulter's REMISOL Advance middleware. Such integration simplifies laboratory workflow and optimizes institutional sepsis management protocols while reducing the operational expense of maintaining costly dedicated instrumentation.

"Laboratories count on Beckman Coulter to provide a broad menu of solutions to help treat the most prevalent and costly health conditions," said Kathleen Orland, senior vice president and general manager for Beckman Coulter's chemistry and immunoassay business. "We are proud to offer the industry's most extensive portfolio of in-vitro diagnostic solutions for sepsis identification and management across multiple disciplines, including the Early Sepsis Indicator, the only hematology-based biomarker FDA cleared specifically for augmenting the diagnosis of sepsis. In the fight against sepsis, every minute counts. Our Access PCT assay is a key component in sepsis identification and treatment, and underscores our ongoing commitment to developing the solutions physicians need to know sooner to act faster."

Access PCT is available for use on Beckman Coulter's Access Family of Immunoassay Systems including the Access 2, UniCel DxI 600 and UniCel DxI 800. For more information regarding the Access PCT assay or Beckman Coulter's full suite of solutions for sepsis diagnosis and management, www.BeckmanCoulter.com/Sepsis.

About Beckman Coulter

Beckman Coulter is committed to advancing healthcare for every person by applying the power of science, technology and the passion and creativity of our teams to enhance the diagnostic laboratory's role in improving healthcare outcomes. Our diagnostic systems are used in complex biomedical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. Beckman Coulter offers a unique combination of people, processes and solutions designed to elevate the performance of clinical laboratories and healthcare networks. We do this by accelerating care with a menu that matters, bringing the benefit of automation to all, delivering greater insights through clinical informatics and unlocking hidden value through performance partnership. An operating company of Danaher Corporation since 2011, Beckman Coulter is headquartered in Brea, Calif., and has more than 11,000 global associates working diligently to make the world a healthier place.

1 Sepsis Alliance. "Fact Sheet.2018." Sepsis.org. Accessed 6 Mar. 2019.

REMISOL Advance is a trademark or registered trademark of Normand-Info SAS in the United States and other countries. Used under license.

© 2020 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.


Source: Beckman Coulter

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