PraediCare Dx is a first-in-class Laboratory Diagnostic Test that is predictive of patients’ response to apoptosis-inducing therapies.
Comforming to regulatory standards:Only commercially available, CLIA-validated apoptosis phenotyping platform with functional readout for hematological malignancies
In clinical use Currently in use in biomarker driven FDA accelerated clinical trial for a CDK9-inhibitor regimen in AML
Applicable to a wide range of therapies,including
Our AML flow cytometry based assay is designed for testing readily available peripheral blood or bone marrow biopsy samples, which are typically obtained during patient diagnosis. Individual tests for several treatment options have been developed and validated in our CLIA-certified laboratory. Results from clinical studies have been published i`n high impact, medical journals. Larger scale verification studies are underway with pharma and academic collaborators.
For CLL patient samples, a fluorescent plate based version of the assay is used for testing patient samples. Initial clinical studies have identified new predictive biomarker biomarker algorithms that predict patient response to those treatments and that forecast on onset of certain adverse events in those patients. Larger verification studies are underway with pharma and academic collaborators to support reimbursement.
For MM patient samples, a fluorescent plate-based version of the assay is used for testing patient samples. Some preliminary clinical studies have identified new predictive biomarker algorithms thatpredict patient response to treatments and that forecast overall survival in those patients. Larger verification studies are underway with pharma and academic collaborators to support reimbursement.