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This article was originally published in The Gray Sheet

Executive Summary

Submits premarket approval application Oct. 3 for the in vitro diagnostic use of its chronic myelogenous leukemia (CML) Mbcr/abl genetic test system. The company says that in multi-center trials involving close to 350 patients, the Oncor test, when used alone, "was 96.1% sensitive and 99.3% specific in detecting CML, compared to the detection rates of a combination of the best presently available methods." The Gaithersburg, Maryland-based firm estimates that its test will cost "five times less than conventional methods"



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