To the max

BALTIMORE, Md.—BD Diagnostics has unveiled a collaboration with Lab21 onthe development of a new molecular diagnostic assay to detect the deadly aspergillusfungus.

Aspergillus has been identified as a leading cause of infectiousdeath in immunocompromised patients, threatening some 10 million peopleannually. 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, reducesmortality from 90 percent to 40 percent—highlighting the need for rapid,accurate testing. Real-time polymerase chain reaction (PCR) may offersignificant advantages in sensitivity and specificity over the current culturetechniques.

Steve Clark, director of marketing at BD Diagnostics, explains that theBD MAX System is a fully automated, benchtop, walk-away system designed to performlysis through PCR detection for different sample types in different assayswithin a single run of one to 24 samples.

The agreement with Lab21 is designed to add an innovative molecular testto the BD MAX System's growing test menu that will empower clinicians andlaboratory professionals with rapid, accurate information on which to baseimportant treatment decisions. The state-of-the-art device being created forthe BD MAX molecular testing system adds to a pipeline of assay products thatnow contains more than 14 offerings. A specific timeline for development andcommercialization has not been announced.

"Our goal is to make the BD MAX System an indispensable tool in clinicallaboratories by providing them with an ever-expanding test menu on a fully automatedplatform," says Tom Polen, president of diagnostic systems at BD Diagnostics.

Real-time PCR principles on which the new BD/Lab21 assay will be basedare thought to offer numerous sensitivity and specificity benefits compared tocurrent culture techniques.

"The potential to detect aspergillusin blood using real-time polymerase chain reaction is a topic of great interestto clinicians since it offers faster, more sensitive and more accuratediagnostic and screening strategies for the early and definitive detection ofaspergillosis," says Graham Mullis, CEO of Lab21.

Lab21 brings to the collaboration the intellectual property anddevelopment capability needed to expedite the specific requirements for the BDMAX system.

"Lab21's marketing and distribution strategy is to identify partners tohelp distribute its world-class assays, products and technology," Mullis notes.

Mullis adds that assay development under the collaboration hascommenced, and Lab21 will work closely with BD Diagnostics for the necessaryregulatory filings. He noted that both parties "will measure the success ofthis collaboration based upon the level of sales generated."

Clark adds that short-term success will be represented by successfullyporting the current assay to the BD MAX, achieving performance goals andentering clinical trials.

"Long-term success will be measured by the establishment of this assayand 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 moleculardiagnostic assays and future content partners in order to expedite and toextend its menu offering for the new BD MAX System.

BD plans to bring new assays to the BD MAX System in a broad range ofdisease categories Polen notes that combined with open capability, fullautomation and standardized workflow, the BD MAX System will enablelaboratories to consolidate and standardize their molecular tests to buildprograms that meet both their current and future clinical needs.