New Immodiagnostic Product for Saliva Proteins

The objective is to design and test components of a novel device for the collection and measurementproteins of saliva. The device is composed of a porous outer membrane to remove particles and mucousenvelope there are beads or membrane coated with antibodies to salivary proteins of interest. A coloto quantitate proteins after transfer of solid phase to a simple detector. The model product developglycated and non-glycated albumin using highly sensitive monoclonal antibodies and an enzyme-linkeddetection protocol easily performed in a medical office. The product will be used in noninvasive moncontrol, and is intended for point-of-care and for home-use. The new device will allow development iother proteins in saliva, including IgA, IgG, apoB subunit of LDL, and can be expanded to viruses anthe upper GI and respiratory tracts. Our commercial goal is to have a range of saliva collection devand market capabilities beyond the current generation SalivaSac¿ which permits capture and quantitat(<12kDa) obtained in an ultrafiltrate of saliva. Phase I is focused on design of a saliva protein codevelopment of solid-phase immunoassays for albumins. Phase I will also test a sample prototype andnormal and diabetic individuals with emphasis on comparison of serum and salivary immunoassayable glnonglycated albumins. Phase II will be concerned with manufacture of a prototype, with enlarging theassayed and with commercialization. Target markets (and analytes) have been selected in response todemands and to provide technologically innovative solutions to clinical research goals of the NIH.