The Eutropics PraediCare Dx? is an emerging clinical diagnostic assay that will be used to predict patient response to specific chemotherapies. Unlike existing assays, PraediCare Dx? predicts response to specific chemotherapies by direct evaluation of cancer cells potential to enter into an apoptotic state following exposure to therapy. PraediCare Dx? has the potential to provide actionable data for guiding the use of available treatment options in numerous cancers. The current iteration of the PraediCare Dx? test measures the functionality of the mitochondria. Mitochondria are the key energy providers within the cell and disruption in their function to signal impacts susceptibility to chemotherapy induced cell death. Our functional biomarker approach has proven predictive value in several blood cancers. The assay is currently being used as a stratification tool to guide clinical treatment in Acute Myelogenous Leukemia (AML). If successful the test will become a Cdx for that treatment and a partnership with the pharma company is now in place. In addition, the platform has been used in Chronic Lymphocytic Leukemia (CML) and Multiple myeloma (MM) clinical studies and will be used to guide treatment in those indications. The company is now in position to provide tailored algorithm readouts as stratifying tools for different clinical trials. Licensing agreements for each Cdx algorithm will provide near term revenues. In addition the clinical test for standard of care has been verified in two separate studies and is nearing commercial launch. Eutropics is also preparing related clinical tests as treatment specific biomarkers for prostate, breast, lung and pancreatic cancers. This next generation PraediCare Dx? platform is now in development and we are in discussions with several pharma companies about partnering the new format, initially for RUO use.
Given the large amount of phenotypic and genetic diversity in AML and MM, the need for predictive tests that can accurately guide use of the growing number of new treatment options is pronounced. The information held in the genetic makeup of the individual and the individual?s tumor holds enormous information, and new technologies have made mining that information practical and amenable to clinical application. There is clearly, though clinically relevant information about the non-genetic, epigenetic, physiologic state of the cancer cell that is available through measurements using various other methods. This information may prove to be additive to genetic measurements to improve sensitivity, or may provide better biomarkers. PraediCare DxTM assay determines the functional sensitivity of cancer cells to cell death to accomplish this goal. Functional characterization of individual patient cancer cells provides insights that can be used to then guide treatment by determining the likelihood that a patient will respond to specific therapies that are dependent on these cell death signals. This information can be used clinically to predict patient response, outcome, or risk for certain adverse events. This strategy can be used to ensure appropriate stratification of patients into biologically relevant subcategories to enable more patient-specific treatment selection.