Gen-Probe regulatory update

Gen-Probe, a subsidiary of Chugai Pharmaceutical Co. Ltd., received FDA approval for its Amplified Mycobacterium Tuberculosis (MTD) diagnostic test. The test provides results in four to five hours with a sensitivity of 95.5 percent and a specificity of 100 percent on smear-positive samples by identifying as few as one TB cell, Gen-Probe said. The test, which was approved in Europe and Japan in 1993 and 1994 respectively, and Canada in 1995, will cost laboratories $25-$30. ...