Qiagen (Hilden, Germany) will collaborate with the Max Planck Institute for Infection Biology's (MPIIB; Berlin, Germany) department of immunology to develop a molecular diagnostic test for tuberculosis. The partners will develop a test aimed at assessing the risk of an individual with latent TB developing active TB disease during his lifetime. Financial terms of the alliance were not disclosed.

Both collaborators will cooperate in collecting, analyzing, and assessing data to identify genetic markers that indicate later development of active TB. Qiagen will be responsible for assay design and manufacturing, while MPIIB will provide access to its marker sets and develop new biosignatures.

Qiagen noted that as a follow-up to those who test positive for latent TB, the new test would be designed to enable early treatment before reactivation of the TB disease, when it becomes contagious and causes life-threatening respiratory illnesses and other diseases.

The assay, based on research conducted at MPIIB, is expected to be polymerase chain reaction (PCR)-based and target multiple biomarkers, said Qiagen. It will run on Qiagen's QIAsymphony platform and serve as a reflex test following Qiagen's QuantiFeron-TB Gold test for detection of latent TB. Qiagen will strengthen its infectious disease portfolio with development of the DNA-/RNA-based test that complements its QuantiFERON-TB Gold test for latent TB.

Resulting kits, which are not expected to be available before 2013, will be marketed by Qiagen.

"We believe that the combination of ‘pre-molecular’ and DNA-/RNA-based molecular testing technologies is the next-generation solution for screening and identifying infected individuals before they develop active TB disease," James Rothel, VP and head of scientific affairs at Qiagen, said in a statement. "This initiative has the potential to reduce the spread of infectious diseases significantly and also to generate cost savings by treating individuals before development of active TB."

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Max Planck Institute for Infection Biology