project: cardiodx

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Product Development Approach

CardioDx begins the product development cycle by identifying where there is an unmet patient need and an opportunity for genomic information to improve the quality of patient care. Multidisciplinary teams at CardioDx, in consultation with external advisors and the broader physician expert community, study and identify critical clinical questions, that if solved, would have the potential to significantly change and improve patient care. Upon identifying a key clinical question, the company designates product specifications and then applies a phased approach to discovery, product development, and clinical validation. By starting with the clinical question, we ensure that our clinical studies, and the genomic tests we develop, have direct relevance to clinicians and can impact patients in real-world clinical practice.

2 0 Diagnostic Programs Overview

From Discovery to Validation

Our experienced clinical and scientific research teams apply multiple "omics" approaches—genomics (genetics and gene expression), proteomics, and/or metabolomics—to the discovery of molecular signals for the defined clinical questions. This typically involves a combination of empirical and hypothesis-driven approaches using the latest available technologies.

For genetics, genome-wide association studies may be used along with candidate gene sequencing. For gene expression profiling, microarrays and whole transcriptome sequencing are employed. The initial discovery work may take advantage of existing retrospective cohorts obtained through collaboration with thought-leading academic centers.

Once leads have been identified, candidate targeted assays are created using technologies such as RT-qPCR that are compatible with rapid translation into clinical practice. Where existing cohort archives are not available, prospective CardioDx-run clinical studies may be designed and implemented. A key feature of these studies is their specific focus on the clinical question at hand, obtainment of suitable samples (for genetics, gene expression, and proteomics) under optimal conditions, and use of core laboratories to define the clinical state of the patient in the most reproducible and accurate way possible.

CardioDx has the research and development infrastructure to effectively manage concurrent, prospective, multicenter clinical programs from discovery to development to validation. Our studies incorporate rigorous scientific and clinical research methods that involve prospectively defined endpoints, independent ongoing data review, and adjudication similar to clinical study methodologies used by medical device and biopharmaceutical companies.