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To the max
September 2011
by David Hutton  |  Email the author


BALTIMORE, Md.—BD Diagnostics has unveiled a collaboration with Lab21 on the development of a new molecular diagnostic assay to detect the deadly aspergillus fungus.
Aspergillus has been identified as a leading cause of infectious death in immunocompromised patients, threatening some 10 million people annually. Early diagnosis can help to greatly reduce fatality rates.
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 (PCR) may offer significant advantages in sensitivity and specificity over the current culture techniques.
Steve Clark, director of marketing at BD Diagnostics, explains that the BD MAX System is a fully automated, benchtop, walk-away system designed to perform lysis through PCR detection for different sample types in different assays within a single run of one to 24 samples.
The 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. The state-of-the-art device being created for the BD MAX molecular testing system adds to a pipeline of assay products that now contains more than 14 offerings. A specific timeline for development and commercialization has not been announced.
"Our goal is to make the BD MAX System an indispensable tool in clinical laboratories by providing them with an ever-expanding test menu on a fully automated platform," says Tom Polen, president of diagnostic systems at BD Diagnostics.   Real-time PCR principles on which the new BD/Lab21 assay will be based are thought to offer numerous sensitivity and specificity benefits compared to current culture techniques.
"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," says Graham Mullis, CEO of Lab21.
Lab21 brings to the collaboration the intellectual property and development capability needed to expedite the specific requirements for the BD MAX system.
"Lab21's marketing and distribution strategy is to identify partners to help distribute its world-class assays, products and technology," Mullis notes.
Mullis adds that assay development under the collaboration has commenced, and Lab21 will work closely with BD Diagnostics for the necessary regulatory filings. He noted that both parties "will measure the success of this collaboration based upon the level of sales generated."
Clark adds that short-term success will be represented by successfully porting the current assay to the BD MAX, achieving performance goals and entering clinical trials.
"Long-term success will be measured by the establishment of this assay and other molecular-based assays becoming standard of practice for rapid, sensitive detection of fungal pathogens in clinical practice," he says.
Mullis says BD Diagnostics is proactively looking for molecular diagnostic assays and future content partners in order to expedite and to extend its menu offering for the new BD MAX System.
BD plans to bring new assays to the BD MAX System in a broad range of disease categories Polen notes that combined with open capability, full automation and standardized workflow, the 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.
Code: E091116



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