MISAA/TacAssay

The seasoned scientists at IOS focus on creating & optimizing sensing at levels of competence not normally seen in industry.Their unique depth and breadth of scientific expertise has enabled IOS to solve challenging physical, chemical, biological, and optical challenges and convert them to extraordinary products. The scientists are driven to succeed by their shared passion for knowledge and growth, and the desire to apply that knowledge to remedy real-world problems, from healthcare to environmental sustainability. MISAA, LLC contains the IP for the TAC Assay and has an operating agreement with IOS to use its scientists, facilities, etc. At MISAA (Monitoring Immunosupressants Anywhere Anytime), our mission is to use our knowledge and experience to improve the health and well-being of the transplant community around the world. FDA 510(k) presub submitted with feedback from the FDA agreeing with our predicate and clearing a 510(k) path forward. The 501(k) is a FDA regulatory process for medical devices which allows them to be approved based on a demonstration of substantial equivalence to a predicate device that is already legally marketed. In other words, we believe we’ll be able to bring this product to market more quickly than a full FDA premarket approval.

Reuben Sandler, PhD CEO of IOS and of MISAA Dr. Sandler spent the early part of his career teaching as a professor of Mathematics at many of the world’s top universities. Then he worked in management consulting for over 10 years specializing in executive development and strategic planning. Then, from 1986 to the present time, he held positions of President, CEO and Chairman of many middle market companies in the information systems, pharmaceutical, medical software and optical sensing industries. Dr. Sandler has a Bachelor of Arts in Mathematics from Reed College and a Master of Science and Doctor of Philosophy from the University of Chicago in Mathematics. Rahul Ganguli, PhD Scientific Advisor to IOS and MISAA Entrepreneurial materials scientist with twenty years of experience in cutting edge R&D in materials science and product development. Possesses a deep understanding of the pressures and drivers for performing contract research, and the large gap that often exists between government funding and successful commercialization. Dr. Ganguli has been successful in bridging this gap through a relentless focus on the end user, and continuous communication between the major stakeholders. Trong Nguyen, PhD Principal Investigator for IOS DoD SBIRs and to MISAA Leads the team developing novel quantitative lateral flow assays for the detection and measurement of biomarkers and drugs in low-volume whole blood and saliva samples. Developed a proprietary optimal buffer formula for each assay and labeling technique based on DNA hybridization that enhances assay sensitivity to sub-nanogram per microliter or low-picogram per milliliter sensitivity levels. Maria Ortega, MS Scientist Assists in the development of rapid biomedical diagnostic assays using immunochemistry and enzymatic technology including optimizing assay conditions and experimental methods to achieve a working biomedical device for the detection and measurement of various biomarkers. Work includes analyzing data and planning experiments for the screening of material, formulating stability solutions for reagents to achieve an appropriate shelf-life, optimizing assay conditions to improve assay sensitivity and achieve measurements in relevant concentration range. Emily Vuu Scientist As a part of the team, optimizes lateral flow assay for detection of biomarkers (tacrolimus, interleukin-6, matrix metalloproteinase-3) in blood and saliva samples. Streamlines luminescent, biochemical fiber optic production for electronic blood pressure sensors.