Vysis files 510(k)s for CML, bone marrow transplant tests, lands broad FISH patent.
This article was originally published in The Gray Sheet
Executive Summary
VYSIS 510(K)s FOR CEP CML, BONE MARROW TRANSPLANT MONITORING TESTS utilizing fluorescence in situ hybridization technology were submitted to FDA July 31 and Aug. 31, respectively, the company says. Both products are chromosome enumeration probes designed to evaluate and count specific chromosomes in metaphases and interphase nuclei. CEP 8, the prognostic indicator and monitoring probe for chronic myelogenous leukemia, detects copies of chromosome 8; the presence of a third copy indicates a poor prognosis. CEP XY monitors sex chromosomes in the blood of a patient following a bone marrow transplant from a patient of the opposite sex.