American Biogenetic Sciences (ABS; Copiague, New York) has entered into a research and non-exclusive license agreement with Biosite Diagnostics (San Diego, California) to validate the use of ABS' thrombus precursor protein (TpP) diagnostic marker and antibodies for potential use with Biosite's rapid, quantitative Triage Meter testing platform. Biosite will conduct an evaluation of the TpP assay as part of its discovery program aimed at the identification of diagnostic markers for cardiovascular and cerebrovascular diseases. If Biosite commercializes any products containing ABS' monoclonal antibodies, it will purchase those antibodies and pay milestone fees and royalties. The TpP assay is based on ABS' MH-1 monoclonal antibody, a product of its patented Antigen-Free antibody generation technology. The diagnostic is approved for use in aiding in the risk assessment of thrombosis and the monitoring of heparin therapy. Biosite's Triage Meter was first commercialized as the testing platform for the Triage Cardiac System, which provides measurements of cardiac markers.
CardioDynamics International (San Diego, California), a developer of impedance cardiography (ICG), and Spacelabs Medical (Redmond, Washington), a provider of integrated medical information systems and instrumentation, have agreed to develop a universal flexport interface to integrate CardioDynamics' BioZ technology with Spacelabs' Ultraview Care Network monitoring system. This will allow BioZ's noninvasive ICG measurements (cardiac output, stroke volume, systemic vascular resistance, and fluid status) to be displayed on Spacelabs monitors. With the universal flexport interface, ICG patient data is integrated on a single screen to provide clinical information, and the data also becomes part of the monitoring system and can be communicated over the network to other locations.
Magna-Lab (Syosset, New York) has retained Eminent Research Systems, a clinical and marketing development management organization, to develop post-clearance marketing information for the company's Cardiac View product. The instrument is a transesophageal magnetic resonance imaging (MRI) receiver coil that is placed, without surgery, directly behind the heart via the nasal passages or esophagus and is intended to aid in the production of MRI images of the heart and coronary vessels. Magna-Lab filed a 510(k) notification with the FDA for the product in February. A focus group of physicians will develop the clinical information needed by physicians to facilitate adoption of the technology in their practices, followed by establishment of clinical protocols for the product to assist in commercialization.