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BD Diagnostics, Lab21 Developing Aspergillus MDx for BD Max Platform

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This article was originally published on Aug. 3.

BD Diagnostics and Lab21 said today that they will collaborate to develop a molecular diagnostic assay to detect Aspergillus fungal infections using the new BD Max Open system.

Under the agreement, BD Diagnostics, a segment of Becton Dickinson, and Cambridge, UK-based Lab 21 will develop the real-time PCR-based test as an in vitro diagnostic product for both the European Union and North American markets, a BD Diagnostics spokesperson said. Financial terms of the agreement were not disclosed.

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," Tom Polen, president of diagnostic systems at BD Diagnostics, said in a statement.

BD Diagnostics said that after striking this agreement with Lab21, there are now "more than 14 assays" in development for the BD Max Open, which the company launched in early May in Europe (PCR Insider 5/12/11) and later that month in the US (PCR Insider 5/26/11).

The BD Max Open is a six-color version of the company's legacy BD Max system, a fully automated, benchtop molecular system that performs cell lysis, nucleic acid extraction, and PCR set-up, amplification and detection. Unlike its predecessor, which itself started out as the HandyLab Jaguar system, the BD Max Open is designed to accommodate molecular diagnostic assays from third-party developers.

Concurrent to the platform's European launch in May, BD Diagnostics said that it was partnering with Diagenode to develop several CE-Marked molecular diagnostic assays for the platform in the area of respiratory, enteric, and central nervous system pathogens.

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, the company said.

BD said in May that it is planning a late-2011 European launch for several CE-IVD-cleared assays it has developed internally, including tests for methicillin-resistant Staphylococcus aureus, Clostridium difficile, and Group B Streptococcus.

Lab21, which is based in Cambridge and has offices in South Carolina, provides diagnostic products and services in the area of blood bank screening, medical diagnostics, and drug discovery.

In May, Lab21 acquired fungal molecular diagnostic firm Myconostica for an undisclosed amount. Myconostica, based in Manchester, UK, had already developed a process for extracting fungal DNA from human samples and a molecular test for Aspergillus, which will presumably now be ported to the BD Max platform.

Aspergillus is a leading cause of death from infectious agents in immunocompromised patients, with an estimated 10 million people at risk globally each year, according to Lab21 and BD Diagnostics.

Studies have shown that diagnosing Aspergillus infections 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 PCR-based testing may offer significant advantages in sensitivity and specificity over current culture techniques, the companies said.

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