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 direct sales, 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
|Zika-Dengue precise immuno-test||Completed||Completed|
|Predictive biomarkers for toxicity in anti-CTLA-4 and anti-PD-1 immune checkpoint therapy||Completed|
|Early diagnosis of lung cancer||Completed||Completed||Completed|
|RA therapeutic outcome prediction||Completed||Completed|
|Precise SLE diagnosis and patient stratification||Completed|
|Non-invasive diagnosis of endometriosis||Completed||Completed|
CDI is in the final stages of development and validation of a protein-based microarray immuno-test which will detect and differentiate a Zika virus infection from other flaviviruses, especially dengue virus, well beyond the viremic state (beyond 10 days post infection).
Current immunoassays can achieve only 70% specificity in differentiating Zika from a dengue infection. This specificity gap represents a major problem for expecting women who are diagnosed with Zika and are then faced with the potential side effects of the disease during pregnancy. In results to date, CDI’s proprietary Zika immunodiagnostic panel has achieved sensitivity and specificity ratios above 90%. Moreover, the test can be enhanced to simultaneously detect other viral infections with a similar clinical presentation, like Chikungunya. This Zika+ test will substantially accelerate and simplify the diagnosis of these co-existing infections. Upon its final validation, CDI will apply for emergency use authorization (EUA) for the test from the FDA and expects to have it on the market within the next 6-10 months.
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).