Roche Amplicor PCR tuberculosis test set for U.S. market launch in January.
This article was originally published in The Gray Sheet
Executive Summary
ROCHE AMPLICOR PCR TUBERCULOSIS TEST U.S. LAUNCH slated for the beginning of January at a price of $25 per test, the company says. Roche Diagnostic Systems gained approval for the test on Nov. 26 for detection of mycobacterium tuberculosis (MTB) in patients who have acid fast bacilli (AFB) positive smear results. The assay is the second gene amplification test approved by FDA for the detection of TB.