Direct Single Test Analysis of Ldl and All Lipoproteins

Period of Performance: 03/01/1997 - 08/31/1998

Unknown

Phase 2 SBIR

Recipient Firm

Atherotech, Inc.
Birmingham, AL 35209
Principal Investigator

Abstract

Of the risk factors associated with coronary artery disease, the most important is inherited dyslipoproteinemia, including elevated LDL. Atherotech proposes to develop a nationwide network of referral laboratories for comprehensive lipoprotein testing based upon the VAP-II procedure. The goal is to provide a single test for diagnosis of abnormalities in the different lipoprotein classes, a test that will be cost effective enough for the physician to follow on a routine basis the effects of treatment on all lipoprotein classes. We have completed Phase I: 1) Validation of the basic VAP-II system has been completed. 2) A valve assembly and the meniscus detector of a more automated VAP-II (AutoVAP-II) has been completed and tested. Phase II: To complete the development of the AutoVAP-II system, five specific aims are proposed: 1) Miniaturize and modularize the Flow Control Sub-system. 2) Develop an automated centrifuge tube loading and puncturing system. 3) Modularize and package the entire AutoVAP-II system into a single box (AutoVAP-II). 4) Validate the finished product. Validation will involve three steps: a) alpha-testing, b) Beta-testing at two remote sites, and c) outcomes research (no funds requested). 5) Complete the development of the LDL VAP-II and HDL VAP-II systems to the point that they can be brought into the clinical laboratory. PROPOSED COMMERCIAL APPLICATION: VAP-II will provide a single test for early diagnosis and of abnormalities in the different lipoprotein classes. This procedure will be cost effective enough for Physicians to follow on a routine basis, the effects and treatment on all lipoprotein classes.