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STUDY FINDS GEN-PROBE'S AMPLIFIED MYCOBACTERIUM TUBERCULOSIS TEST MORE SENSITIVE THAN PCR IN DETECTING M. TUBERCULOSIS

 SAN DIEGO, Jan. 13 /PRNewswire/ -- A study completed by Japanese researchers and published in the December 1993 edition of The Journal of Clinical Microbiology reported that Gen-Probe's Amplified Mycobacterium Tuberculosis Direct Test (MTD) is more sensitive and specific than the Polymerase Chain Reaction (PCR) in detecting the presence or absence of Mycobacterium tuberculosis in samples taken directly from patients.
 Tuberculosis (TB) has re-emerged as an important public health concern in the United States. The increasing incidence of AIDS, drug abuse, homelessness and immigration coupled with incorrect or incomplete administration of antibiotics to infected individuals is associated with the rise in cases of tuberculosis, especially those cases involving drug-resistant strains of the bacteria. An estimated 10 million to 15 million Americans are infected with TB, and about 10 percent will develop the disease this year. Worldwide, 1.7 billion -- or nearly one- third of the world's population -- are infected with TB, and the number of new cases exceeds 8 million per year.
 The study was performed using 135 specimens taken from patients admitted to Fukujuji Hospital. The specimens were divided for use in comparing Gen-Probe's MTD test with PCR and to compare both tests to culture, the gold standard for Mycobacterium testing. The two tests were also compared to direct smear testing which, although rapid, cannot distinguish between different species of Mycobacterium. Smear testing also requires a relatively large number of bacteria to be present in the sample.
 Culture is highly accurate but takes weeks or months to complete. Rapid diagnosis of tuberculosis is important to prevent spread of the disease and reduce the high cost of patient isolation. In comparison, the MTD and PCR tests are extremely rapid and provide results in only a few hours, according to the study.
 The authors of the paper were: Chiyoji Abe, Kazue Hirano, Masako Wada, Yuko Kazumi, Mitsuyoshi Takahashi and Yutaka Fukasawa from The Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Kiyose shi, Tokyo; Tadashi Yoshimura, Chieko Miyagi and Susumu Goto from Diagnostic Research Laboratory, Chugai Pharmaceutical Co. Ltd., Toshima- ku, Tokyo.
 In the study, MTD and PCR were assessed to determine their ability to specifically detect M. tuberculosis when the organism was present in extremely small quantities.
 The results of the study demonstrated that although both tests had good performance, Gen-Probe's MTD test was better able to determine the presence or absence of the specific bacteria being targeted, especially when very few organisms were found in the specimen. After resolution of discrepant results, the MTD system exhibited a sensitivity and specificity of 91.9 percent and 100 percent, respectively. After similar resolution, PCR demonstrated a sensitivity of 84.2 percent and a specificity of 100 percent. In comparison, smear examination and culture of the specimens gave sensitivities of 71.9 percent and 96.9 percent, respectively.
 The scientists involved in this study noted Gen-Probe's MTD test had several important advantages over PCR in detecting as many infected patients as possible. In the study, MTD, which tests for the presence of ribosomal RNA (present by the thousands of copies in each bacterial cell), was found to be more sensitive than PCR, which tests for DNA strands that are found in much lower quantities. The MTD test was also described as a much simpler, enclosed procedure which greatly reduced the likelihood of false positive results, while providing rapid generation of the target sequence present in the sample. Furthermore, PCR requires expensive thermal cycling equipment, while the MTD test uses only simple heat blocks.
 With tuberculosis on the rise, Gen-Probe hopes to provide its MTD test as an effective and rapid alternative to traditional diagnostics, thereby reducing TB-related fatalities and treatment costs for those infected.
 Gen-Probe Inc. is based in San Diego. It is the recognized world leader in the development, manufacture and commercialization of diagnostic products based on its patented genetic probe technologies.
 -0- 1/13/94
 /CONTACT: Tom Gable or Kris Lichter, Gable/Versaggi Biocommunications, 619-234-1300/


CO: Gen-Probe Inc. ST: California IN: MTC SU:

MF-LS -- SD005 -- 1674 01/13/94 08:31 EST
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Date:Jan 13, 1994
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