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Mayo Clinic Licenses IP from Qiagen to Develop PCR Test for TB Speciation

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Mayo Clinic said this week that it has licensed patent rights from Qiagen that will enable Mayo Medical Laboratories to offer a molecular complex speciation test for tuberculosis.

Under the agreement, Mayo has obtained the rights to US Patent No. 7,749,696, entitled "Method and kit for the specific detection of M. tuberculosis," which was issued to Qiagen in July 2010.

As described in the patent's abstract, the invention relates to a method and system for specifically detecting M. tuberculosis in a biological sample; and in particular using a SNP in a narGHJI promoter to differentiate between M. tuberculosis and other elements of M. tuberculosis complex such as M. bovis, M. bovis BCG, M. africanum, and M. microti.

In an email to PCR Insider, Nancy Wengenack, director of the Mycobacteriology Laboratory in Mayo's Department of Laboratory Medicine and Pathology, said that the new test will be based on real-time PCR using fluorescence resonance energy transfer probes for detection.

The new test will also expand Mayo Medical Labs' current offering for TB testing, which includes M. tuberculosis complex culture, molecular identification, and drug susceptibility. In addition, MML offers PCR detection of M. tuberculosis complex directly from specimens and molecular detection of resistance markers for the drugs isoniazid and pyrazinamide.

Mayo said that MML currently routinely identifies M. tuberculosis complex in the laboratory using nucleic acid hybridization probes approved by the US Food and Drug Administration; however, this approach cannot distinguish between M. tuberculosis and the species that are covered by the Qiagen technology.

Additional terms of the licensing agreement were not disclosed.

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