SBIR-STTR Award

Of the risk factors associated with coronary artery disease, the most important is inherited dyslipoproteinemia, including elevated LDL. VAP, Inc. 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. Commercial viability will depend upon the accuracy and reliability of a VAP-II test and its cost. Phase I: To develop VAP-II to the point that it is a commercially viable product, two specific aims are proposed in phase I: I) Complete the validation of the basic VAP-II system. 2) Develop the valve assembly and the meniscus detection components of a more automated VAP-II (AutoVAP-II). AutoVAP-II is of great important for developing a competitive cost structure for VAPII; a properly designed AutoVAP-II can reduce technician time by one- half to one-third, the major cost associated with the procedure. Phase II: To complete the development of the AutoVAP-II system, three specific aims are proposed: 1) Develop an automated centrifuge tube loading and puncturing system, 2) package the entire AutoVAP-II system into a single box, and 3) validate the finished product.

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.