Science
Core CapabilitiesDGx is uniquely positioned to develop highly accurate diagnostic tests based on its well-established technology platform which provides highly correlative gene signatures for healthcare events of interest. DGx uses state-of-the-art genomics technologies and sophisticated biostatistics to quickly identify and validate gene signatures that form the groundwork for the development of critically needed molecular diagnostic assays and improve patient management for difficult-to-manage diseases likeMS. This is possible due to the unique set of assets DGx has at its disposal. These assets include the experience of the DGx management team in identifying and validating gene signatures as clinical biomarkers; access to BioExpress®; and access to an extensive clinical network of thought leaders.
DGx' experience and capabilities provide a clear competitive advantage, having been in the business of providing such high quality results to its partners for years. This fidelity and reproducibility are driven by the quality control measures found at critical points in DGx multi-step, multi-technology, product development process. This well-established system was key to the discovery and qualification of a unique and patentable multiplex MS biomarker set as illustrated below:
Click image for larger, more detailed version (GIF 300 kb)
Once sentinel marker sets are found, DGx continues to utilize its deep understanding of human biology to uncover the molecular mechanisms that are driven by specific dysregulated genes associated with key biological pathways involved in the early stages of MS. Connection of the “biological dots” is extremely important as DGx continues to select the best discriminating markers for a given test.
The Practice of Neurology & MS
DGx’ primary market research suggests that the current MS diagnostic process is invasive, inaccurate, time consuming and expensive. Unfortunately, current MS diagnostic tests, even when accurate, fail to adequately inform treatment decisions or provide prognostic information about disease severity (see Appendix 2). In fact, the current diagnostic schema (Figure 1) is driven by the inaccuracy of individual Dx tests.
Figure 1 – Multiple Opportunities to Improve MS Healthcare
The current standard of care requires the use of a series of invasive tests (e.g., MRI, LP-based CSF tests and EVP tests) that rely on the skill and experience of the practitioner to interpret data from disparate assays only to provide an estimate as to the likelihood a patient has MS. The patient must then make a critical healthcare decision; either proactively start aggressive injectable immunomodulating therapy or forgo therapy and continue diagnostic monitoring for months or years before receiving a definitive diagnosis. DGx is confident that it can fill this significant unmet need by providing the patient and practitioner with accurate, personalized information to help reduce the anxiety and improve the patient’s healthcare.
DioGenix's Capabilities Can Be Applied to Many Diseases
DGx’s assets and capabilities are disease-agnostic, providing a foundation to quickly build a pipeline and intellectual property estate of molecular diagnostic opportunities lead by a battery of MS, thyroid cancer and Parkinson’s tests.
One of the critical elements that allows DGx to accelerate the development of its molecular diagnostic programs across such diverse disease states is its network of existing relationships with thought leaders in each of these clinical disciplines. These relationships are disease-centric partnerships which leverage the clinical experience and practice of key collaborators to:
• Identify appropriate disease targets with large market potential;
• Participate in the design of clinical studies;
• Assist in identification of key opinion leaders in the area;
• Provide critical patient samples for analysis;
• Assist in the identification and validation of marker sets; and
• Act as alpha- and beta-test sites for DGx’s MDx assays.
DGx retains all commercial rights to the resultant molecular diagnostics products while sharing in a more robust understanding of disease biology with its collaborators, allowing for publications and grant work that is an off-shoot of our diagnostic programs.
