SEARCHCardioDx®, a pioneer in the field of cardiovascular genomic diagnostics, is committed to improving the quality of care for patients with cardiovascular disease through the research, development, and validation of clinically important genomic tests that enable clinicians to better assess and individualize care for patients. The company is strategically focused on three cardiovascular disease areas: coronary artery disease (CAD), cardiac arrhythmia, and heart failure.
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 management decisions. Multidisciplinary teams at CardioDx, in consultation with external advisors and the broader cardiology community, study and identify critical clinical questions, the answers to which have the potential to significantly change and improve patient care. Upon identifying a key clinical question, the company develops a product specification and applies a phased approach to discovery, product development, and validation. By starting with the clinical questions first, we ensure that our clinical studies, and the genomic tests we develop, have direct relevance to clinicians and patients in real-world clinical practice.
Our experienced clinical and scientific research teams apply multiple genomics approaches (genetics, 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 techniques available.
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 from collaborators.
Once promising signals have been obtained, prospective CardioDx-run clinical studies are designed and implemented. A key feature of these studies is their specific focus on the clinical question at hand, obtainment of multiple 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, multi-center clinical programs from discovery to development to validation. Our studies incorporate rigorous scientific and clinical research methods that involve ongoing data review and adjudication, at a similar level to clinical study methodologies used by medical device and biopharmaceutical companies.
