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The Diagnostic Utility of the in-vitro "Provoked" D dimer test in patients with suspected pulmonary embolism

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL145842-01
Agency Tracking Number: R41HL145842
Amount: $148,864.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA18-575
Solicitation Year: 2018
Award Year: 2019
Award Start Date (Proposal Award Date): 2019-09-20
Award End Date (Contract End Date): 2020-08-31
Small Business Information
3504 TURNBERRY LANE, Martinez, GA, 30907-9541
DUNS: 080773201
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: Y
Principal Investigator
 (706) 721-2592
Business Contact
Phone: (706) 495-5436
Research Institution
 1120 15TH STREET
AUGUSTA, GA, 30912-0004
 Nonprofit college or university
Project SummaryThe D Dimer assay is the current diagnostic standard to exclude patients of VTE due to its high sensitivityHoweverD Dimer levels are commonly elevated in patients without thromboembolismleading to poor specificity and poor positive predictive valuePPVDue to the lack of a robust diagnostic tool for VTEwe propose a novel advancement upon current DDimer testing which improves specificity through the addition of thrombolytics in vitro to increase the degradation of fibrin multimers present from the incomplete digestion of the in vivo fibrin rich clotThis increases the D Dimer signal in instances of a true clotThe elevation in theprovokedD DimerPDDsignal in comparison to the baselineor Standard D DimerSDDcan be used to improve the specificity and PPV of the D Dimer assayOur patented D Dimer test appears to move the field towards these goals but requires further study aimed at understanding the characteristic and efficacy of commercially available thrombolyticsThe PDD assay is a simplerapidand economical detection method for thromboembolism which improves specificity and PPV while maintaining high SDD sensitivityOur PDD assay has U Sand Europe patents which coverof the $billion worldwide market and we are currently seeking to commercialize our discoveryOur discussions with hemostasis diagnosis companies has lead us to two top prioritiesDetermine optimal incubation time and concentration needed for commercially available thrombolytics to establish their role in performing the provoked D dimer methodologyTo evaluate the test characteristics of all commercially available thrombolytic agents in effecting the new provoked D dimer methodology so that the most durable and effective agent can be utilizedTo accomplish thiswe are applying for the Small Business Technology TransferSTTRPhaseaward to stimulate clinical application of our patented technological innovationDrRobinson is from an underrepresented minorityAfrican Americanwhere the STTR mission is to foster and encourage participation in innovation and entrepreneurship in this groupClinicallywe anticipate with our PDD a true screening test will now be developed for patients with potential thromboembolismThe potential areas which will be impacted in the future are cryptogenic strokeatrial fibrillation risk stratificationscreening of immobile individualsand defining thromboembolic risk in cardiomyopathic patientsProject Narrative Venous ThromboembolismVTEis a major cause of disability and death in the United StatesWe plan to optimize a new blood test which promises to simplify the diagnosis of VTE in humansIf goals of our project are achievedit will result in reduced death and morbidity from venous thromboembolic diseases

* Information listed above is at the time of submission. *

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