Complications of T2D represent one third of the total cost of US$174Bn in USA, according to the American Diabetes Society. Current methods for assessing the risk of complications of T2D rely on traditional biological and clinical biomarkers that altogether have a generally a limited predictive value of less than 70%.
We propose that the combined use of traditional biomarkers and genomic markers developed by Prognomix will yield to a significant increase of the predictive value and, consequently, to an increased adherence of clinicians to available preventive measures leading to a significant reduction in the health care costs associated with complications of T2D. The products and services offered by Prognomix will also benefit to the pharmaceutical industry by helping selection of patients to be included in clinical trials and providing means to better target drug treatments.
Prognomix currently has under development four products, all indicated for use in T2D patients:
PGX IR01: Individual Risk Product
PGx IR01 is an in vitro molecular predictive test for assessing the risk of complications in patients with T2D. PGx IR01 combines a set SNP (and eventually CNV) markers with established biological and clinical markers to produce, using a proprietary algorithm, a risk score predictive of clinically significant and preventable complications in diabetic patients, such as coronary artery disease, stroke or renal insufficiency. SNPs were identified by Genome-Wide Association Studies (GWAS) performed in T2D patients from the ADVANCE trial. The GWAS was run as a case-control study where cases were subjects with complications of T2D while subjects without complications recruited into ADVANCE trial for longer diabetes duration and/or older age were used as controls.
PGx GR01: Group Risk Product
PGx GR01 is an in vitro molecular screening test designed for selection of diabetic patients at higher risk of cardiovascular events, to aid in safety outcome trials to be conducted during the development of therapeutic products for T2D by reducing sample size and/or trial duration. PGx GR01 is a Research Use Only tool, designed in alignment with the FDA Guidance for Industry for Diabetes Mellitus-Evaluating cardiovascular risks in new antidiabetic therapies to treat type 2 diabetes (Center for Drug Evaluation and Research, December 2008), requiring a demonstration that a new antidiabetic therapy is not associated with an unacceptable increase in cardiovascular risk. PGx GR01 combines a set of SNP (and eventually CNV) markers with established biological and clinical markers to select, using a proprietary algorithm, subjects at higher risk of cardiovascular events, such as Major Adverse Cardiovascular Events (MACE), in diabetic patients.
PGx CD01: Companion Diagnostic Product
PGx CD01 is an in vitro molecular companion diagnostics to be developed in parallel with new drugs or indications for prevention (including primary prevention) of cardiovascular and/or renal complications of T2D. The drugs will be used as a preventive intervention aimed at avoiding complications in a high risk diabetes subset population identified by the diagnostic test. The test may also comprise drug specific efficacy biomarkers. PGx CD01 combines a set of SNP (and eventually/ CNV) markers with established biological and clinical markers to identify, using a proprietary algorithm, T2D subjects in whom the drug administration confers the possibility of pre-symptomatic prevention of complications.
PGx CD01 is meant to be part of pharmaceutical product life cycle management, to extend the indication of drugs to primary prevention using a genetic test to identify a risk population.
PGx IR02: Individual Risk Product
Since SNPs and copy number variants (CNVs) are non-modifiable DNA markers, their determination will be performed only once for each patient using PGX IR01 product. However, time and environment-dependent changes in DNA, including telomere shortening and epigenetic changes such as methylation pattern are becoming clinically relevant. PGx IR02 will be developed to include these DNA age/time modifiable parameters as well as other non-genomic biomarkers subject to variation.