Monday, July 18, 2011
ROCHESTER, Minn. — 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.
The Department of Laboratory Medicine and Pathology at Mayo Clinic maintains an active diagnostic test development program. This program incorporates Mayo discoveries and expertise and also discoveries from other diagnostic and biotechnology companies and leading academic and research organizations. Mayo utilizes these proven diagnostic technologies in the care of its patients and offers them to more than 5,000 health care institutions around the world through Mayo Medical Laboratories. Revenue from testing is used to support medical education and research at Mayo Clinic.
QIAGEN N.V., a Netherlands holding company, is the leading global provider of sample and assay technologies. Sample technologies are used to isolate and process DNA, RNA and proteins from biological samples such as blood or tissue. Assay technologies are used to make such isolated bio-molecules visible. QIAGEN has developed and markets more than 500 sample and assay products as well as automated solutions for such consumables. The company provides its products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN's assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV Test, which is regarded as a "gold standard" in testing for high-risk types of human papillomavirus (HPV), the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. QIAGEN employs nearly 3,600 people in over 30 locations worldwide. U.S. patent 7,749,696 issued July 6, 2010, entitled "Method and kit for the specific detection of M. Tuberculosis" by inventor Franz-Christoph Bange, Assignee Qiagen Diagnostics GmbH.
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