O.N. DIAGNOSTICS, LLC — Department of Health and Human Services SBIR Phase II: NIAMS

Description

DESCRIPTION provided by applicant Osteoporosis is a major public health threat for over of the population over age with over million Americans estimated to have osteoporosis and another million at increased risk due to low bone mass Additionally over osteoporotic hip and spine fractures are reported annually in patients over age Despite the clinical importance of osteoporosis it is under diagnosed and under treated with only of those who need testing receiving it To rectify this O N Diagnostics has developed andquot ancillary BCTandquot for clinical use BCT combines image processing of CT scans bone biomechanics and finite element analysis to provide estimates of BMD and whole bone strength from patient CT scans The goal of this SBIR project is to develop the ability to provide these BMD and bone strength measures using a wide range of typical clinical CT exams in which the BCT analysis is performed as an andquot add onandquot analysis to a CT exam that was ordered for a non osteoporosis indication thereby enabling the identification of those patients at high risk o hip and spine fracture while removing the patient inconvenience of undergoing a dedicated osteoporosis scan and maximizing the cost effectiveness of pre existing imaging exams We estimate that up to million CT scans taken each year in the U S contain the hip or spine and would be technically suitable for ancillary BCT analysis Our plan is to offer ancillary BCT to those CT patients who meet the current clinical criteria to have a DXA exam but who have not yet had a DXA In Phase I of this project we successfully developed software VirtuOst to assess both bone strength and BMD using previously acquired clinical CT scans This Phase II project will focus on the remaining technical challenges to the full clinical implementation of ancillary BCT In Aim we will improve throughput and reliability by automating image processing steps and integrating automatic quality assurance testing into the analysis workflow eliminating the procedural overhead associated with an analysis and reducing the cost to no more than that of a DXA exam Utilizing existing image processing steps we will add vertebral facture assessment to add value to BCT In Aim we will optimize our phantomless calibration technique using patient specific estimates of x ray beam energy that will allow repeatable BCT result regardless of CT scanner or acquisition protocol We will extend BCT analysis to the of abdominal CT exams acquired with intravenous contrast and address monitoring guidelines for ancillary BCT Finally in Aim we will integrate all these advances into a clinical study featuring multiple CT scanners and exam types acquired from a large and demographically diverse patient population Focusing on clinical translation we will also perform a cost effectiveness analysis to determine the most efficient exam types to analyze and which patients would benefit most from ancillary BCT from a health economics perspective At the end of this SBIR study we will have expanded the scope and clinical utility of ancillary BCT analysis to at risk patients without DXA exams but with existing CT exams and determined which of these patients BCT will benefit most PUBLIC HEALTH RELEVANCE With a mortality rate up to one year after hip fracture and an economic burden exceeding $ billion annually osteoporotic fracture is a debilitating condition whose impact on our aging society is growing Early identification of those at risk for fracture can guide prevention and treatment and BCT will provide a means for such detection with improved fracture risk classification compared to DXA based bone densitometry The greater radiation exposure from CT however limits the market for such a diagnostic The proposed project will result in a robust diagnostic test that lowers radiation dose to the patient y using CT scans already ordered for other medical purposes Successful development of this product will broaden the pool of individuals who will benefit from an improved fracture risk prediction expand the market for O N Diagnosticsandapos business and result in an important advance in the preventative care and treatment of osteoporosis