Gen-Probe Inc. announced that its Amplified MycobacteriumTuberculosis Direct Test (MTD) has been approved for marketing inJapan. The test has already been cleared for marketing in Europe,and the company said it hopes to have it on the market in the U.S. inmid-1994.
The test combines proprietary Gen-Probe technologies involvingribosomal RNA targets, transcription-mediated amplification and ahomogenous assay-detection format known as the hybridizationprotection assay. The company said the test can be carried out withina four-hour period in a single test tube without thermal cycling. Astudy recently published in The Journal of Clinical Microbiologyconcluded that the test is more sensitive and specific thanpolymerase chain reaction (see BioWorld, Jan. 14).
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