Test Development: Acute Myeloid Leukemia Example

Nodality's first validated clinical test is for the prediction of response to induction chemotherapy in Acute Myeloid Leukemia (AML). Nodality scientists discovered several novel biomarkers associated with clinical response to standard induction therapy. Nodes tested included growth factor responsive nodes, cytokine responsive nodes, and apoptosis-related nodes. Clinical development was completed in collaboration with the cooperative groups ECOG, COG, and SWOG. The unique algorithm was superior to standard diagnostic criteria such as age and cytogenetic testing results. Additionally, the test increased the predictive value when combined with traditional clinical factors such as age, cytogenetic status, and performance status. For additional information, please see the publications page. The test was designed to run in Nodality's CLIA-certified reference laboratory. The test was also developed according to FDA Design Control and related principles.

Nodality recommends that partners collect samples according to a standard cryopreservation procedure (PDF: 971K) which Nodality has determined to be optimal for SCNP. If you have any questions about this protocol or any of the global facilities that Nodality has qualified to perform this protocol for SCNP, please contact us.

Therapeutic Areas