SBIR-STTR Award

A test system for rapid screening of patients prior to initiation of thrombolytic therapy will be developed. This system will be based on a novel dry reagent assay technology which recently has been applied successfully to PT and activated PTT tests. Introduction of a rapid convenient test of patient (or clot) lytic potential for use on a decentralized basis could provide early indication of likelihood of success with streptokinase sooner than existing laboratory methods and could serve as an important diagnostic guide in thrombolytic therapy.We will develop this test system and to assess its potential using a combination of laboratory studies and clinical sample studies. Application to early determination of clot lysis response in patients prior to thrombolytic therapy will be explored. This work will be performed in conjunction with investigators at University of North Carolina at Chapel Hill. Phase I support would fund assay optimization activities and clinical sample feasibility studies.Awardee's statement of the potential commercial applications of the research:This research has the potential to provide new diagnostic products for improvement of thrombolytic therapy.National Heart, Lung and Blood Institute (NHLBI)

A Phase I SBIR program has been completed to develop an assay system for monitoring functional fibrinogen in patients undergoing thrombolytic therapy. This prototype system can measure STAT fibrinogen with a disposable dry chemistry test card and portable analyzer using a single drop of freshly drawn whole blood sample. The study extended previous work of the past 3 years with earlier prototype fibrinogen assays. The new assay has demonstrated potential for rapid test turnaround time, greater convenience, and consequently improved diagnostic capability. Preliminary performance characteristics of the assay, potential influencing factors, and application to early determination of low fibrinogen levels in thrombolytic therapy were explored. Further development during the Phase II program will focus on: finalizing the dry chemistry test card for pilot production; calibration, standardization and translation of assay results to clinically meaningful fibrinogen values; completing the analyzer software; performing clinical comparison studies with a reference method on samples from thrombolytic therapy patients; extending comparison studies to patients with a variety of disorders; and utilizing the assay for decentralized testing by non- laboratory trained personnel in multiple test sites. Testing in clinical environments will be performed in conjunction with Research Triangle Area Medical Centers.