VerifyNow System

The assay device consists of the following components:

• Finger Grip: Each assay device has a handle with which the user can insert or remove the assay device from the assay device port.
• Staging Well: The blood sample is held in this area for temperature stabilization prior to analysis.
• Assay Device Spot Code: Each assay device is labeled with a unique spot code. Upon insertion of the assay device into the assay device port, the instrument automatically scans the spot code and determines which assay is being performed, records the lot number, and verifies that the assay device has not expired.
• Sample Well: The sample well is the area of the assay device where the blood collection tube is inserted. The well contains a Blood Collection Tube Spike for sampling directly from a closed blood collection tube. A protective sheath is removed from the assay device spike before use.
• Humidity Indicator: Each assay device has a humidity sensor to determine whether the assay device has been exposed to excess humidity.
• Mixing Chamber/Detection Wells: The wells contain all necessary reagents for the specific assays.

The GP IIb/IIIa inhibitor class of intravenous antiplatelet agents, has demonstrated benefit in treating patients undergoing coronary interventions (e.g. PTCA and stent placement) and acute coronary syndromes. Currently available drugs in this class include ReoPro (Centocor), Integrilin (Millenium Pharmaceuticals) and Aggrastat(Merck & Co.). Accumetrics estimates that over 2.5 million patients annually are candidates for intravenous antiplatelet therapy. Data from clinical trials suggest that both the safety and efficacy of these agents are dependent on achieving a specific level of receptor blockade. Since there are individual variations in the response to these agents, Accumetrics' first product is targeted to address this unmet medical need.

Aspirin, the most commonly used antithrombotic medication in the world, prevents heart attack, stroke, and other vascular events by causing platelet dysfunction, so that platelets will not aggregate. Over 20 million people in the U.S. alone take aspirin daily to prevent platelets from clotting. Clinical data shows that not all patients receive the full benefits of aspirin, therefore it is important to ensure that patients are receiving the expected anti-platelet benefits. Accumetrics second product is designed to address this important medical need.