Invitrox Technologies is an early stage diagnostic company based in Research Triangle Park, North Carolina. Invitrox Technologies utilizes its specialized expertise in the field of microparticle research and cell-surface assays to develop novel diagnostics and personalized drug monitoring.
The Company is focused on commercialization of our cell-based assay portfolio and providing lab services to pharma clients utilizing two proprietary technologies: ISADE™ and EQELS™. Both technology platforms are revolutionary laser light scattering techniques developed by Invitrox Technologies.
Both technologies have broad applicability across multiple disease states. To date our technologies have been utilized in various disease states including acute coronary syndrome, cancer, hepatology, and autoimmune diseases. These devices and the corresponding assays will offer pharma companies a competitive edge when dealing with the increasingly greater need
• Lead compound identification
• Lead compound optimization
• Rapid assay through-put
• Specific lead compound assay development
• Product differentiation (wide variety of methods)
• Improved protocol subject identification and selection
• Dose and schedule optimization
• Identification of potential side effects (especially hematologic)
• New drug indications
• Individual patient monitoring for dose (post FDA approval)
Our in vitro lab services to date have utilized these technologies to help pharma companies determine drug profiles such as pharmacodynamics, kinetics, etc. Outputs are used to develop companion diagnostics, optimize drug profiles for clinical development programs, detect diseases (such as Acute Coronary Syndrome and Minimal Residual Disease), and determine the presence of microparticles (in blood as well as in drug products such as freeze-dried plasma). Both ISADE and EQELS have usefulness throughout the drug development process from lead compound optimization to identification of specific patient populations to Phase 4 post-marketing trials to companion diagnostics.
ISADE (Invitrox Technologies Surface Antigen Detection Enumerator) is a light-scattering device with distinct microparticle detection and analysis capabilities; in initial trials, results appear to be more specific at lower level detection limits than flow cytometry! ISADE provides the ability to get more detailed results with greater specificity in a shorter timeframe.
The literature is filled with current research around the potential clinical and diagnostic importance of microparticles in many disease states. Cell activation and cell death (apoptosis) generate microparticles – cell fragments that are present in the bloodstream and mimic the surface characteristics of the activated or apoptotic cells of origin. Detection and accurate identification of the number and phenotype of microparticles can provide the earliest evidence of cell damage, which can be beneficial to clinical diagnostic procedures and therapeutic monitoring.
Acute Coronary Syndrome is typically initiated by plaque rupture. When this occurs, surrounding endothelial cells and platelets are activated. Activation of these cells generates microparticles that are released from the surface of these cells and carry with them biomarkers that can provide early clinical prognostic information useful in directing specific therapy that can minimize irreversible heart muscle damage. Microparticles bearing epitopes, such as CD144, CD146, CD31, CD54, CD62p, CD41, CD40, are postulated to identify patients that may need emergent cardiac catheterization and stent placement before sufficient ischemia to damage the heart has occurred. Of great significance is that microparticles bearing these phenotypes are present in blood before the usual biomarkers like troponins and CK-MB isoenzymes are elevated. Through the use of ISADE’s CardMI™ assay, the ability to reduce the time to stent placement is shortened, minimizing the severity of heart damage and subsequent patient disability, as well as providing significant cost savings to the healthcare system.
Since endothelial injury is involved in many different diseases, broader applications for microparticles derived from endothelium are clearly possible. It is known that microparticles are elevated in acute renal failure, renal graft rejection, preeclampsia, and other kidney diseases. Microparticles may be found in blood as well as urine in these conditions.
This technology has allowed us to help clients determine the activity of drugs, the impact of the drug on non-target cells, toxicity profiles, and drug binding capabilities. We have also worked with clients to help them meet FDA requirements for marketed compounds by showing the presence/absence of microparticles in injectables.
Medical College of Virginia
University of North Carolina
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