INTELLIGENT OPTICAL SYSTEMS, INC. — Department of Health and Human Services SBIR Phase II: NIDCR

Description

DESCRIPTION provided by applicant Bone is a dynamic tissue that continually undergoes new bone formation by osteoblasts and old bone resorption by osteoclasts their rates are in balance throughout all life stages but a gradual loss of bone density occurs with aging In some people an abnormal balance of bone loss occurs osteoporosis with a lifetime risk of fracture of the hip spine or forearm of in white women and in white men age andgt years Osteoporosis is a systemic disease and andquot silent epidemicandquot that is usually diagnosed at a late stage frequently after a fracture Bone mineral density BMD loss associated with osteoporosis can be measured reliably by dual photon absorptiometry DPA quantitative computed tomography QCT or dual energy X ray absorptiometry DEXA Although these diagnostic methods measure BMD accurately they are expensive and time and energy intensive compared to point of care tests moreover the hardware is not amenable to miniaturization Similarly biomarkers excreted in serum or urine usually assessed by enzyme linked immunoassay ELISA laboratory testing are not offered for routine screening and treatment follow up for time and cost reasons To address these limitations and as a simple noninvasive easy to use cost effective and routine means of diagnosing bone turnover Intelligent Optical Systems IOS is developing a platform based on a simple lateral flow assay LFTA technique developed previously by IOS for monitoring salivary markers of bone turnover This will enable clinicians to perform routine noninvasive screening for osteoporosis in a point of care POC setting The simple LFA platform immobilized with specific reagents sensitive to multiple bone loss salivary biomarkers is designed to target clinically relevant detection limits n less than min with the required level of sensitivity and specificity for non invasive reliabl screening The gold standard for validating the study will be absolute and relative BMD as measured by QCT imaging analysis of the lumbar spine L L using a phantom with known quantities of hydroxyapatite The Phase I research effort established assay platforms for salivary bone loss markers OC and DPD The assays exhibited sensitivity that is relevant to clinical requirements showing a high degree of correlation with patient diagnosis A prospective clinical study confirmed excellent correlation of OC with both bone mineral density BMD and the gold standard ELISA biomarker measurement kits for saliva and blood samples In Phase II we will expand the clinical testing of the established marker detection to include an extensive human prospective study to determine the statistical reliability and the effects of race age and diet in a larger population PUBLIC HEALTH RELEVANCE A new non invasive salivary based bone loss marker detection platform is proposed for routine screening of bone loss biomarkers via an inexpensive non invasive method that can be employed in point of care POC testing Routine screening will result in earlier detection of bone loss which in turn will result in more effective treatmen options improving the quality of life of osteoporotic patients The simplicity of the assay technique and its noninvasiveness speed reliability and low cost will enable us to position this technology for a number of clinical applications including prognostic tools for patients unde therapeutic treatment