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BD Diagnostics to Add to BD Max Test Menu Pipeline with Transplant Patient Dx Pact

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BD Diagnostics and Italian biotech firm Biodiversity said today that they will collaborate to develop a comprehensive molecular diagnostic menu for testing immunocompromised patients on the BD Max system, adding to the pipeline of assay content for the recently launched platform.

Under the agreement, Biodiversity, based in Bescia, will develop a portfolio of molecular assays to detect infections in immunocompromised patients using the BD Max system's open architecture.

Assays developed through the collaboration will be CE marked for sale and distribution in Europe, with future expansion to additional regions, the companies said.

Following a transplant, patients are typically treated with immunosuppressants to prevent rejection, thus putting them at high risk for infection. Assays developed by Biodiversity for use on the BD Max will allow clinical laboratories to run assays on multiple samples and for multiple infectious agents simultaneously, potentially leading to earlier diagnosis and treatment for immunocompromised patients, the companies said.

BD Diagnostics launched its "open architecture" version of the BD Max in Europe in early May; and in the US two weeks later (PCR Insider 5/12/11 and 5/26/11).

The six-color, fully automated, bench-top system performs cell lysis, nucleic acid extraction, and PCR set-up, amplification, and detection; and is designed to accommodate a broad range of molecular tests — including in vitro diagnostic assays and laboratory-developed tests — as well as user-defined protocols and life science research applications.

BD has been working to secure partnerships with content providers. Concurrent to the European launch of BD Max, the company said it had signed an agreement with Belgium's Diagenode to develop seven CE-marked molecular diagnostic assays for the system focused on pathogens associated with respiratory, enteric, and central nervous system diseases.

Prior to the system's official launch, BD Diagnostics also inked an agreement with Swiss pharmaceutical firm Lonza to develop and commercialize molecular assays on the BD Max for pharmaceutical quality control (PCR Insider, 10/28/10). And earlier this month, BD Diagnostics and Lab 21 announced that they would co-develop a molecular diagnostic assay to detect Aspergillus fungal infections using the molecular testing platform (PCR Insider, 8/4/11).

In a statement this week, Tom Polen, president of BD Diagnostics, said that there are now more than 15 assays in the BD Max's menu pipeline, and that the company plans to bring many more new assays to the system in a broad range of disease categories.

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