SBIR-STTR Award

VitaMe Technologies Inc. and Cornell University will develop the FePhone - a point-of-care diagnostic system for iron status determination. The FePhone comprises of (1) a test cartridge which accepts the blood sample and performs the test, (2) a TidBit reader a custom portable hardware system developed by Cornell which operates the test, and (3) a mobile app which provides step-by-step instructions for performing the test, communicates with the TidBit, interprets the test outcomes, and provides the desired OK, Iron Deficiency, or Iron Deficiency Anemia result to the operator. The FePhone system builds on our existing NutriPhone platform which is a point of care system which serves to diagnose micronutrient deficiencies in 10 minutes from a finger stick of blood and has already been validated for in human trials for cholesterol, vitamin D, and vitamin B12. We have also already accomplished preliminary validation of an iron status test comprising of a multiplexed sTfR, serum ferritin, and CRP. The proposed work will be split between Cornell and VitaMe with Cornell focusing on assay development and final validation and VitaMe performing the fabrication for high-volume chip production, constructing a second generation reader system, app development, and preparing for FDA approval.

VitaMe Technologies Inc. (doing business as VitaScan) and Cornell University will develop the Iron.Scan - a point-of-care system for iron deficiency and anemia diagnosis in about 10 minutes from a finger stick of blood. The system comprises of (1) an Iron.Scan test cartridge that analyzes 4 key biomarkers associated with anemia and iron deficiency and (2) a VitaScan reader that provides quantitative results as well as iron status OK, Iron Deficiency, or Iron Deficiency Anemia interpretation based on a proprietary algorithm we have developed. The Iron.Scan system builds on our Phase I accomplishments in: proposing, developing and validating the novel multiplexed biomarker assay and creating the first generation VitaScan instrument and software. In the initial stages of the Phase II effort VitaScan will finalize development of the Iron.Scan assay and diagnostic system and begin to pursue FDA 510(k) approval. To complement these efforts Cornell will perform arms length unbiased human validation studies of the system by analyzing recruited female student athletes. Once human validation is complete, VitaScan will work with the DoD to deploy and test its system at an Air Education Training Command military installation to assess usability in a military health care setting.