SBIR-STTR Award

A Global Test of Hemostatic Risk
Award last edited on: 4/5/19

Sponsored Program
STTR
Awarding Agency
NIH : NHLBI
Total Award Amount
$801,552
Award Phase
2
Solicitation Topic Code
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Principal Investigator
Richard Jenny

Company Information

Haematologic Technologies Inc (AKA: Haematologic Technologies LLC)

57 River Road Unit 1021
Essex Junction, VT 05452
   (802) 878-1777
   hti@haemtech.com
   www.haemtech.com

Research Institution

University of Vermont and St Agric College

Phase I

Contract Number: 1R41HL076904-01
Start Date: 8/16/04    Completed: 6/30/09
Phase I year
2004
Phase I Amount
$99,039
Although the vast majority of patients who suffer from venous or arterial thrombosis have haemostatic systems that fall within the "normal" range of routine screening tools such as PT, aPTT, and factor assays, thrombosis is the major cause of death in Western countries. In contrast, the propensity to bleed (i.e., hemophilia) is more easily diagnosed by traditional assay methodology yet the extent of the pathology and the clinical management of these individuals is not accurately portrayed by these same assays. Para vivo models of blood coagulation developed at the University of Vermont have clearly demonstrated a correlation between an individual's potential to generate thrombin and several haemostatic defects. The assay system utilized in these studies is based on a tissue factor initiated whole blood clotting technique in which thrombin generation is monitored via quantitation of thrombin-antithrombin m complex formation. We propose to modify and make clinically accessible this existing comprehensive method of monitoring the haemostatic competence of whole blood. In phase I of this proposal, we will conduct studies to demonstrate the feasibility of commercializing this research based assay. The successful completion of this Phase I proposal will demonstrate the feasibility of producing an easy to use, marketable global test in the arena of clinical hemostasis testing that is sensitive to antithrombotic drugs, bleeding disorders and thrombotic pathologies. This assay will offer significant cost advantages over current technologies by potentially replacing the need to perform multiple assays to determine an individual's haemostatic risk potential.

Thesaurus Terms:
blood coagulation, blood test, clotting factor, disease /disorder proneness /risk, hemostasis, technology /technique development, thrombosis antithrombin III, hemostatic, phospholipid, plasma, thrombin, thrombin receptor clinical research, enzyme linked immunosorbent assay, human tissue

Phase II

Contract Number: 2R42HL076904-02
Start Date: 00/00/00    Completed: 00/00/00
Phase II year
2007
(last award dollars: 2008)
Phase II Amount
$702,513

Phase I funding for this project supported successful studies that were aimed at demonstrating the feasibility of developing an easy to use, global test in the arena of clinical hemostasis that would be sensitive to antithrombotic drugs, bleeding disorders and thrombotic pathologies. This test comprises a measurement of the rate of thrombin generation and/or total thrombin potential in a non-perturbed, tissue factor-dependent system. Prior to the Phase I study, this test existed as a complicated ten-plus step research based assay that could only be performed by highly skilled and trained technicians. During the Phase I project period we simplified the assay by developing a blood collection tube containing the components necessary for the initiation of coagulation (relipidated tissue factor) and suppression of the contact phase of coagulation (corn trypsin inhibitor). The development of this tube reduces the complexity of the initial steps in the assay since issues of timing along with the formulation and rapid addition of reagents becomes irrelevant. Once the tube was prepared we were able to optimize assay conditions to yield reproducible results that compared nicely to those obtained with the original research-based assay. Additional accomplishments include the development of a stable quench solution, the design and manufacture of a prototype temperature-controlled assay chamber and the initial development of our own thrombin-antithrombin-III (TAT) ELISA. Collectively, the accomplishments associated with the Phase I project period demonstrate our ability to produce all elements necessary for the thrombin-generation assay (TGA). Phase II funding is being requested to support the efforts that are associated with the further refinement, assembly and validation of the complete assay system. This project is devoted to the development of a "Global Test of Hemostatic Risk" that could ultimately identify individuals in the apparently "normal" population who are at risk for the future development of hemostatic complications (thrombosis or bleeding disorders). Furthermore, this test may facilitate the administration and monitoring of individualized therapeutic treatment regimens in the thrombotic and hemorrhagic patient populations.

Thesaurus Terms:
antithrombin III, cardiovascular disorder risk, diagnostic test, enzyme linked immunosorbent assay, hemostasis, thrombin blood coagulation, blood coagulation disorder, diagnosis design /evaluation, hemostatic, reagent /indicator, technology /technique development, thrombosis clinical research, human tissue