Gen-Probe Inc.'s amplified test to rapidly diagnosistuberculosis was approved by the FDA.
The Gen-Probe Amplified Mycobacterium TuberculosisDirect Test, indicated for smear-positive previouslyuntreated patients, takes only four to five hours to getresults. Current methods take two to eight weeks inculture.
The test targets ribosomal RNA rather than DNA, whichthe company said makes the test more specific andreliable. Transcription mediated amplification is anothertechnology used to develop the test, which has asensitivity of 95.5 percent and specificity of 100 percent.The technology also includes a hybridization protectionassay and a chemiluminescent label to identify only M.tuberculosis gene sequences that have bound to geneticprobes, helping avoid false positives.
"This is definitely a medical breakthrough," said BruceHuebner, vice president, sales and marketing, for SanDiego-based Gen-Probe. "It will allow the physician tohave a result that says whether TB is present or not withinfour to five hours after the sample is submitted."
Gen-Probe, which is expecting more than $72 million in1995 diagnostic sales, will sell the product through itsdirect sales organization. The company, a wholly ownedsubsidiary of Tokyo-based Chugai Pharmaceutical Co.Ltd., is expecting "several million dollars" in first-yearsales and, in five years, more than $20 million in sales forthis type of product, Huebner said.
The company said there are about 10 million Americansinfected with the tuberculosis bacterium, 10 percent ofwhom will develop active tuberculosis. n
-- Jim Shrine
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