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BD and Lab21 Collaborate to Develop Aspergillus Assay for New BD MAX™ Molecular Testing System

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BD Diagnostics, and Lab21 have announced a collaboration to develop a molecular diagnostic assay to detect the life-threatening Aspergillus fungus using the new fully automated BD MAX™ Molecular Testing System.

“The potential to detect Aspergillus in blood using real-time polymerase chain reaction is a topic of great interest to clinicians since it offers faster, more sensitive and more accurate diagnostic and screening strategies for the early and definitive detection of aspergillosis,” said Graham Mullis, CEO of Lab21.

Infection caused by Aspergillus is a leading cause of infectious death in immunocompromised patients, with an estimated 10 million people at risk globally each year.

Studies have shown that diagnosis of Aspergillus infection followed by antifungal treatment within the first 10 days of infection reduces mortality from 90 percent to 40 percent - highlighting the need for rapid, accurate testing.

Real-time polymerase chain reaction may offer significant advantages in sensitivity and specificity over the current culture techniques.

“This agreement with Lab21 is designed to add an innovative molecular test to the BD MAX System’s growing test menu that will empower clinicians and laboratory professionals with rapid, accurate information on which to base important treatment decisions,” said Tom Polen, President, BD Diagnostics - Diagnostic Systems.

Polen continued, “By collaborating with best-in-class in vitro diagnostics developers such as Lab21, our goal is to make the BD MAX System an indispensible tool in clinical laboratories by providing them with an ever-expanding test menu on a fully automated platform.”

According to Polen, BD plans to bring new assays to the BD MAX System in a broad range of disease categories. With this announcement, there are now more than 14 assays in the BD MAX System’s content-rich menu pipeline.

Combined with open capability, full automation and standardized workflow, BD MAX System will enable laboratories to consolidate and standardize their molecular tests to build programs that meet both their current and future clinical needs.