Mayo Clinic Licenses Patent Rights for M. tuberculosis Complex Speciation

Mayo Clinic has licensed patent rights from QIAGEN to enable Mayo Medical Laboratories to offer an M. tuberculosis complex speciation test. The test expands Mayo Medical Laboratories’ current offering for tuberculosis testing, which already includes M. tuberculosis complex culture, molecular identification and drug susceptibility testing. In addition, Mayo Medical Laboratories offers polymerase chain reaction (PCR) detection of M. tuberculosis complex directly from specimens and molecular detection of drug resistance markers for the drugs isoniazid and pyrazinamide.

Tuberculosis (TB) is a disease caused by M. tuberculosis complex. The bacteria usually attack the lungs, but also can attack other parts of the body such as the kidney, spine and brain. If not treated properly, TB disease can be fatal. Tuberculosis once was the leading cause of death in the United States. If left untreated, it can kill over 50 percent of its victims.

Mayo Medical Laboratories routinely identifies M. tuberculosis complex in the laboratory using Food and Drug Administration (FDA)-approved nucleic acid hybridization probes. This approach is appropriate when the physician wants to confirm that the patient is infected with M. tuberculosis complex but cannot tell the physician if the culprit is the species M. tuberculosis or another species member of the complex, such as M. bovis, M. bovis BCG and M. africanum.

“When the clinical history of a patient suggests that it might be one of these other members of the complex, the physician will ask for speciation to know which species, usually M. tuberculosis, M. bovis, or M. bovis BCG, is causing the patient’s disease. The treatment plan and the public health contact investigation associated with TB disease may differ depending on which species has been identified,” explains Nancy Wengenack, Ph.D., director of the Mycobacteriology Laboratory, Mayo Clinic Department of Laboratory Medicine and Pathology.