Biomarkers & Diagnostics Pipeline
CDI is taking advantage of the power of its cutting edge discovery tools and workflows. At CDI we not only empower the biomarker discovery projects of our clients, but we also engage in partnerships and projects to discover novel biomarkers with diagnostic and prognostic potential. We plan to take all of our internal discoveries to market via various commercialization channels, including strategic collaborations and licensing. CDI is working with global leaders in the several fields in which our discoveries bring new levels of precise diagnosis and prognosis, thus impacting precision medical treatment. Please contact us to discuss potential projects or collaborations.
Current CDI R&D Initiatives
|IN ADVANCE STAGES OF DEVELOPMENT:|
|Lung cancer biomarkers
|IN THE PIPELINE:|
|Diagnostic biomarkers for endometrial cancer||Completed||Completed|
|Predictive biomarkers for toxicity & outcome in
anti-CTLA-4 and anti-PD-1 immune
|Novel SLE (Lupus) biomarkers for
Biomarker Development/Patient Screening
Immune Checkpoint Inhibitors:
With over 20,000 protein reactions tested for each blood sample, patient screening is another high-growth market which CDI has identified for its protein microarray technology platform. CDI, in collaboration with a leading medical research university, has already identified promising biomarker candidates that can be utilized to screen out patients likely to suffer toxic side effects of immune checkpoint inhibitor therapies such as anti-PD-1, anti-CTLA-4, anti-PD-L1 etc.
The project is currently expanding the patient cohorts being tested for a thorough validation of the discovered panels with clinical-grade microarrays available within the next 12-18 months. Upon validation, CDI expects that the Company’s screening tests will be rapidly incorporated into the testing regime of ongoing immune checkpoint inhibitor therapy clinical trials, which use will not require FDA approval.
Nonetheless, the company also expects to find a strategic partner to seek FDA approval of the CDI biomarker screening, in order to market these tests as part of the medical criteria for the immune checkpoint therapies.
Even as research tools, however, CDI’s screening tests will result in more successful clinical trials and a better standard of care for the patient in the development of new drug therapies. This first commercial biomarker panel will also spur new discovery partnerships with CDI to identify and market new biomarker panels for the several hundred immune checkpoint inhibitor therapies currently under development.
In another collaborative effort with a major proteomic researcher, CDI has identified a promising biomarker panel for the early detection of lung cancer with excellent sensitivity and specificity results to date. As a low cost, non-invasive alternative to current diagnostic tools, CDI believes that this proteomic test has the potential for rapid adoption, as it can become part of the yearly checkup for smokers and ex-smokers.
To date, the results of CDI’s diagnostic test show that it can detect all variants of lung cancer at much earlier stages than the competing technologies. With an 18-36 month development timeline, the Company is actively looking for partners in order to accelerate the development of this research program into the validation and commercialization stages.
CDI has established research collaborations and active programs to identify biomarker panels and create tests in areas such as rheumatoid arthritis (RA) therapy response prediction, precise systemic lupus erythematosus (SLE) diagnosis & patient stratification, non-invasive endometriosis diagnosis. These biomarker tests will allow more precise diagnosis (lupus, endometriosis), and cost-effective treatments (RA).