Application
IVDiagnostics is focused on creating highly sensitive and affordable cancer assays, molecular diagnostics, and minimally invasive approaches to diagnosing patients and determining the effectiveness or ineffectiveness of therapy.
The company is developing a portfolio of IVD CTC assays for those tumor types that have a high percentage of non-localized metastases. *These tumor types include the following based on data from the American Cancer Society and the National Institutes of Health.
- Breast Cancer: 209,060 projected new cases; 40,230 estimated deaths.
- Colon Cancer: 102,900 projected new cases; 51,370 estimated deaths.
- Kidney Cancer: 58,240 projected new cases; 13,040 estimated deaths.
- Leukemia: 43,050 projected new cases; 21,840 estimated deaths.
- Lung Cancer: 222,520 projected new cases; 157,300 estimated deaths.
- Ovarian Cancer: 21,880 projected new cases; 13,850 estimated deaths.
- Pancreatic Cancer: 43,140 projected new cases; 36,800 estimated deaths.
*The American Cancer Society’s most recently published data for 2010 illustrates the severity of ever-growing incidence projections based on rates from the North American Association of Central Cancer Registries (NAACCR) from 1995-2006, representing about 89% of the US population. Estimated deaths were based on data from US Mortality Data, 1969-2007, National Center for Health Statistics, Centers for Disease Control and Prevention, 2010.
In addition to IVD CTC Assays, the company is developing a medical device that will allow physicians to enumerate, isolate, and eradicate CTCs in vivo. Thus, the company is extending the clinical benefit of its platform to allow physicians a treatment option.
The ability to accurately detect CTCs in blood circulation of a cancer patient with our advanced technology represents a potential breakthrough in cancer disease management. IVDiagnostics is developing technology designed to detect, count, and characterize the CTCs that are shed into the blood and ultimately cause the cancer metastases that constitute 99% of the mortality among cancer patients. Our preclinical studies on metastatic cancer indicate that our products provide quantitative and reproducible results that give physicians predictive information to improve patient management. Our in vivo platform is truly an innovative technology that will allow physicians to diagnosis one liter of blood within 30-40 minutes without taking patient blood samples.
With additional research and development, IVDiagnostics will be able to use this platform for other types of blood borne diseases including infectious diseases, inflammatory diseases, and the monitoring of certain types of bacteria and proteins all with the objective of minimally or non-invasive approaches to determining what is happening with the body. If we can move toward this goal, the company will certainly make an impact on assisting physicians with the move toward personalized medicine.
Our approach is rapid development and prototyping, thus leading to preclinical studies that are driven by input from medical advisors. Utilizing this approach, the company has a well-defined path to regulatory approval.
In doing so, IVDiagnostics welcomes and encourages collaboration with several academic and institutional partners. By collaborating in such areas as the use and application of new biomarkers, we can create clinically sound assays and protocols that are relatively easy to follow. By working together with medical centers dedicated to improving clinical outcome, we believe that IVDiagnostics can make a significant impact on patient care.
