Nuclea has developed an in situ hybridization assay for the rapid and accurate identification of the major bcr/abl (Mbcr/abl) gene fusion and c-kit (CD117) amplification status in
patients having or suspected of having a lymphoproliferative disorder characterized by the presence of the Mbcr/abl gene fusion and c-kit (CD117) expression. Nuclea's assay simultaneously detects both the presence of Mbcr/abl gene fusion and c-kit (CD 117) amplification in a single biological sample of patients having or suspected of having CML or another lymphoproliferative disorder.
Preliminary data suggests that Nuclea's assay may be highly specific for lymphoproliferative disorders characterized by the presence of the Ph chromosome and c-kit (CD 117), including CML, AML and ALL, and thus may be used for the differential diagnosis and monitoring of disease progression, as well as for predicting the efficacy of certain therapeutic agents. Nuclea's assay may be highly predictive of the efficacy of therapeutic agents which are inhibitors of tyrosine kinase, the BCR/ABL fusion protein and c-kit (CD117), such as imatinib mesylate ( Gleevec® ), dasatinib ( Sprycel® ) or nilotinib.